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Nicorette White Ice Prescribing Information

Package insert / product label
Generic name: nicotine polacrilex
Dosage form: gum, chewing
Drug class: Smoking cessation agents

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

Active ingredient (in each chewing piece)

Nicotine polacrilex (equal to 2 mg nicotine)

Nicotine polacrilex (equal to 4 mg nicotine)

Purpose

Stop smoking aid

Indications and Usage for Nicorette White Ice

  • reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider.

Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Ask a doctor before use if you have

  • a sodium-restricted diet
  • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
  • high blood pressure not controlled with medication. Nicotine can increase blood pressure.
  • stomach ulcer or diabetes
  • history of seizures

Ask a doctor or a pharmacist before use if you are

  • using a non-nicotine stop smoking drug
  • taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

  • mouth, teeth or jaw problems occur
  • irregular heartbeat or palpitations occur
  • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat
  • (For Cinnamon Surge)oral blistering occurs
  • you have symptoms of an allergic reaction (such as difficulty breathing or rash)

Keep out of reach of children and pets.

Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Nicorette White Ice Dosage and Administration

  • if you are under 18 years of age, ask a doctor before use
  • before using this product, read the enclosed User’s Guide for complete directions and other important information
  • begin using the gum on your quit day
  • if you smoke your first cigarette within 30 minutes of waking up,use 4 mg nicotine gum
  • if you smoke your first cigarette more than 30 minutes after waking up,use 2 mg nicotine gum according to the following 12 week schedule:

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 piece every 1 to 2 hours

1 piece every 2 to 4 hours

1 piece every 4 to 8 hours

  • nicotine gum is a medicine and must be used a certain way to get the best results
  • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
  • repeat this process until most of the tingle is gone (about 30 minutes)
  • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
  • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
  • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
  • do not use more than 24 pieces a day
  • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Nicorette White Ice Dosage and Administration

  • if you are under 18 years of age, ask a doctor before use
  • before using this product, read the enclosed User’s Guide for complete directions and other important information
  • begin using the gum on your quit day
  • if you smoke your first cigarette more than 30 minutes after waking up,use 2 mg nicotine gum
  • if you smoke your first cigarette within 30 minutes of waking up,use 4 mg nicotine gum according to the following 12 week schedule:

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 piece every 1 to 2 hours

1 piece every 2 to 4 hours

1 piece every 4 to 8 hours

  • nicotine gum is a medicine and must be used a certain way to get the best results
  • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.
  • repeat this process until most of the tingle is gone (about 30 minutes)
  • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece
  • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks
  • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.
  • do not use more than 24 pieces a day
  • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider

Other information (White Ice Mint)

  • (2 mg) each piece contains:calcium 94 mg, sodium 11 mg
  • (4 mg) each piece contains:calcium 94 mg, sodium 13 mg
  • store at 20 - 25 oC (68 - 77 oF)
  • protect from light

Other information (Original)

  • each piece contains:calcium 117 mg, sodium 13 mg
  • store at 20 - 25 oC (68 - 77 oF)
  • protect from light

Other information (Cinnamon Surge)

  • (2 mg) each piece contains:calcium 94 mg, sodium 11 mg
  • (4 mg) each piece contains:calcium 94 mg, sodium 13 mg
  • store at 20 - 25 oC (68 - 77 oF)
  • protect from light

Other information (Fresh Mint)

  • (2 mg) each piece contains:calcium 94 mg, sodium 11 mg
  • (4 mg) each piece contains:calcium 94 mg, sodium 13 mg
  • store at 20 - 25 oC (68 - 77 oF)
  • protect from light

Other information (Mint)

  • (2 mg) each piece contains:calcium 94 mg, sodium 13 mg
  • (4 mg) each piece contains:calcium 94 mg, sodium 14 mg
  • store at 20 - 25 oC (68 - 77 oF)
  • protect from light

Other information (Spearmint Burst)

  • (2 mg) each piece contains:calcium 94 mg, sodium 11 mg
  • (4 mg) each piece contains:calcium 94 mg, sodium 13 mg
  • store at 20 - 25 oC (68 - 77 oF)
  • protect from light

Inactive ingredients (White Ice Mint)

each 2 mg piece contains:acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, starch, sucralose, titanium dioxide, xylitol

each 4 mg piece contains:acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, starch, sucralose, titanium dioxide, xylitol

Inactive ingredients (Original)

each 2 mg piece contains:flavors, glycerin, gum base, sodium bicarbonate, sodium carbonate, sorbitol

each 4 mg piece contains:D&C yellow #10, flavors, glycerin, gum base, sodium carbonate, sorbitol

Inactive ingredients (Cinnamon Surge)

each 2 mg piece contains:acacia, acesulfame potassium, carnauba wax, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol

each 4 mg piece contains:acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

Inactive ingredients (Fresh Mint)

each 2 mg piece contains:acacia, acesulfame potassium, carnauba wax, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, titanium dioxide, xylitol

each 4 mg piece contains:acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, titanium dioxide, xylitol

Inactive ingredients (Mint)

each 2 mg piece contains:acesulfame potassium, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, xylitol

each 4 mg piece contains:acesulfame potassium, D&C yellow #10 Al. lake, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, xylitol

Inactive ingredients (Spearmint Burst)

each 2 mg piece contains:acacia, acesulfame potassium, carnauba wax, edible ink, flavors, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol

each 4 mg piece contains:acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavors, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

Questions and comments?

call toll-free 1-800-419-4766

Additional information found on packaging

TO INCREASE YOUR SUCCESS IN QUITTING:

  1. You must be motivated to quit.
  2. Use Enough– Chew at least 9 piecesof Nicorette gum per day during the first six weeks.
  3. Use Long Enough– Use Nicorette gum for the full 12 weeks.
  4. Use with a support programas directed in the enclosed User’s Guide.

To remove the gum, tear off single unit.

Peel off backing, starting at corner with loose edge.

Push gum through foil.

  • not for sale to those under 18 years of age
  • proof of age required
  • not for sale in vending machines or from any source where proof of age cannot be verified

This product is protected in sealed blisters. Do not use if individual blisters or printed backings are broken, open, or torn.

Distributed by

GSKConsumer Healthcare

Warren, NJ 07059

Made in Sweden

For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.comor see inside for more details.

Principal Display Panel

NDC 0135-0474-02

Nicorette ®

nicotine polacrilex gum, 2 mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

White Ice Mint ®

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette® 4 mg Gum

100 PIECES,2 mg EACH

©2016 GSK or its licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

30462XG

30462XG_Nicorette White Ice Mint 2 mg_ 100ct.JPG

Principal Display Panel

NDC 0135-0475-02

Nicorette ®

nicotine polacrilex gum, 4 mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

White Ice Mint ®

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette 2 mg Gum

100 PIECES,4 mg EACH

©2016 GSK or its licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

30463XG

30463XG_Nicorette White Ice Mint gum 4 mg_100 ct.JPG

Principal Display Panel

NDC 0135-0157-07

Nicorette ®

nicotine polacrilex gum, 2 mg • stop smoking aid

Gum

Original

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4mg Gum

110 PIECES,2 mg EACH

©2016 GSK group of companies or its licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

29545XG

29545XG_Nicorette original gum 2 mg_110 ct.JPG

Principal Display Panel

NDC 0135-0158-07

Nicorette ®

nicotine polacrilex gum, 4 mg • stop smoking aid

Gum

Original

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette® 2 mg Gum

110 PIECES,4mg EACH

©2015 GSK group of companies or its licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

29546XG

29546XG_Nicorette original gum 4 mg_110 ct.JPG

Principal Display Panel

NDC 0135-0466-02

Nicorette ®

nicotine polacrilex gum, 2 mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Cinnamon Surge™

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4mg Gum

100 PIECES,2 mg EACH

©2016 GSK group of companies or its licensor.

Trademarks are owned by or licensed o the GSK group of companies.

30214XG

30214XG_Nicorette Cinnamon Surge 2 mg_100 ct.JPG

Principal Display Panel

NDC 0135-0467-02

Nicorette ®

nicotine polacrilex gum, 4 mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Cinnamon Surge™

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette 2 mg Gum

100 PIECES,4 mg EACH

©2016 GSK group of companies or its licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

30215XG

30215XG_Nicorette Cinnamon Surge 4 mg_100 ct.JPG

Principal Display Panel

NDC 0135-0225-02

Nicorette ®

nicotine polacrilex gum, 2 mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Fresh Mint TM

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Gum

100 PIECES,2 mg EACH

©2016 GSK group of companies or its licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

29547XI

29547XI_Nicorette Fresh Mint gum_100 ct.JPG

Principal Display Panel

NDC 0135-0226-02

Nicorette ®

nicotine polacrilex gum, 4 mg • stop smoking aid

Gum

Coated

FOR BOLD FLAVOR

Fresh Mint TM

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette® 2 mg Gum

100 PIECES,4 mg EACH

©2016 GSK group of companies or tis licensor. All rights reserved.

Trademarks are owned by or licensed to the GSK group of companies.

29548XI

29548XI_Nicorette Fresh Mint gum 4 mg_100ct.JPG

Principal Display Panel

NDC 0135-0229-04

Nicorette ®

nicotine polacrilex gum, 2mg • stop smoking aid

Gum

Mint

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4mg Gum

110 PIECES,2mg EACH

©2014 GSK

NICORETTE and the NICORETTE sunburst design are registered trademarks of the GSK group of companies.

29552XG

Nicorette Mint gum 2mg 110 count carton

Principal Display Panel

NDC 0135-0230-04

Nicorette ®

nicotine polacrilex gum, 4mg • stop smoking aid

Gum

Mint

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette 2mg Gum

110 PIECES,4mg EACH

©2014 GSK

NICORETTE and the NICORETTE sunburst design are registered trademarks of the GSK group of companies.

29553XG

Nicorette Mint Gum 4mg 110 count carton

Principal Display Panel

NDC 0135-0532-02

Nicorette

nicotine polacrilex gum, 2 mgstop smoking aid

Gum

NEW FLAVOR

Coated FOR BOLD FLAVOR

Spearmint Burstwith a hint of chamomile

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Gum

100 PIECES, 2 mg EACH

Trademarks are owned by or licensed to the GSK group of companies.

©2017 GSK group of companies or its licensor. All rights reserved.

101782XC

101782XC_Nicorette Spearmint Burst gum 2 mg_100 ct.JPG

Principal Display Panel

NDC 0135-0533-02

Nicorette

nicotine polacrilex gum, 4 mgstop smoking aid

Gum

Coated FOR BOLD FLAVOR

Spearmint Burstwith a hint of chamomile

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette 2 mg Gum

100 PIECES, 4 mg EACH

Trademarks are owned by or licensed to the GSK group of companies.

©2017 GSK group of companies or its licensor. All rights reserved.

101781XC

101781XC_Nicorette Spearmint Burst 4 mg_100 ct.JPG

Principal Display Panel

NDC 0135-0355-03

Nicorette

nicotine polacrilex gum, 4 mgstop smoking aid

Gum

Coated FOR BOLD FLAVOR

Spearmint Burstwith a hint of chamomile

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette 2 mg Gum

160 PIECES, 4 mg EACH

Trademarks are owned by or licensed to the GSK group of companies.

©2017 GSK group of companies or its licensor. All rights reserved.

105941XB

105941XB_Nicorette Spearmint Burst 4 mg_160 ct.JPG
NICORETTE WHITE ICE MINT
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0474
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
ColorwhiteScoreno score
ShapeSQUARESize15mm
FlavorMINT (White Ice Mint) Imprint CodeN2
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0474-011 in 1 CARTON06/29/2009
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0474-021 in 1 CARTON06/29/2009
2100 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0474-051 in 1 CARTON06/29/2009
3160 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0135-0474-0820 in 1 CARTON; Type 0: Not a Combination Product06/29/2009
5NDC:0135-0474-1425 in 1 CARTON; Type 0: Not a Combination Product06/29/200908/01/2018
6NDC:0135-0474-158 in 1 PACKAGE06/29/200908/01/2018
625 in 1 CARTON; Type 0: Not a Combination Product
7NDC:0135-0474-171 in 1 CARTON06/29/2009
710 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC:0135-0474-182 in 1 PACKAGE08/01/2014
810 in 1 CARTON
810 in 1 BLISTER PACK; Type 0: Not a Combination Product
9NDC:0135-0474-1912 in 1 CARTON09/01/2018
910 in 1 BLISTER PACK; Type 0: Not a Combination Product
10NDC:0135-0474-2018 in 1 CARTON12/03/2018
1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01861206/29/2009
NICORETTE WHITE ICE MINT
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0475
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
Colorwhite (cream) Scoreno score
ShapeSQUARESize15mm
FlavorMINT (White Ice Mint) Imprint CodeN4
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0475-011 in 1 CARTON06/29/2009
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0475-021 in 1 CARTON06/29/2009
2100 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0475-031 in 1 CARTON06/29/200908/01/2019
3190 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0135-0475-051 in 1 CARTON06/29/2009
4160 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:0135-0475-0820 in 1 CARTON; Type 0: Not a Combination Product06/29/2009
6NDC:0135-0475-1425 in 1 CARTON; Type 0: Not a Combination Product06/29/200908/01/2018
7NDC:0135-0475-158 in 1 PACKAGE06/29/200908/01/2018
725 in 1 CARTON; Type 0: Not a Combination Product
8NDC:0135-0475-171 in 1 CARTON06/29/2009
810 in 1 BLISTER PACK; Type 0: Not a Combination Product
9NDC:0135-0475-182 in 1 PACKAGE08/01/2014
910 in 1 CARTON
910 in 1 BLISTER PACK; Type 0: Not a Combination Product
10NDC:0135-0475-1912 in 1 CARTON09/01/2018
1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
11NDC:0135-0475-2018 in 1 CARTON12/03/2018
1110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006606/29/2009
NICORETTE ORIGINAL
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0157
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
SORBITOL (UNII: 506T60A25R)
Product Characteristics
Colorwhite (beige) Scoreno score
ShapeSQUARESize14mm
FlavorImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0157-071 in 1 CARTON06/29/2009
1110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0157-101 in 1 CARTON06/29/2009
2170 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0157-111 in 1 CARTON06/29/2009
3200 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0135-0157-121 in 1 CARTON06/29/200908/01/2019
4220 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01861206/29/2009
NICORETTE ORIGINAL
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0158
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CARBONATE (UNII: 45P3261C7T)
SORBITOL (UNII: 506T60A25R)
Product Characteristics
Colorwhite (beige) Scoreno score
ShapeSQUARESize14mm
FlavorImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0158-071 in 1 CARTON06/29/2009
1110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0158-101 in 1 CARTON06/29/2009
2170 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0158-111 in 1 CARTON06/29/2009
3200 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0135-0158-121 in 1 CARTON06/29/200908/01/2019
4220 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006606/29/2009
NICORETTE CINNAMON SURGE
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0466
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
ColorwhiteScoreno score
ShapeSQUARESize15mm
FlavorCINNAMONImprint CodeN2
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0466-011 in 1 CARTON06/29/2009
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0466-021 in 1 CARTON06/29/2009
2100 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0466-031 in 1 CARTON06/29/2009
3190 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0135-0466-051 in 1 CARTON06/29/2009
4160 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:0135-0466-071 in 1 CARTON06/29/2009
540 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:0135-0466-0820 in 1 CARTON; Type 0: Not a Combination Product06/29/2009
7NDC:0135-0466-1425 in 1 CARTON; Type 0: Not a Combination Product06/29/200908/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01861206/29/2009
NICORETTE CINNAMON SURGE
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0467
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
Colorwhite (cream) Scoreno score
ShapeSQUARESize15mm
FlavorCINNAMONImprint CodeN4
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0467-011 in 1 CARTON06/29/2009
120 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0467-021 in 1 CARTON06/29/2009
2100 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0467-051 in 1 CARTON06/29/2009
3160 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0135-0467-071 in 1 CARTON06/29/2009
440 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:0135-0467-0820 in 1 CARTON; Type 0: Not a Combination Product06/29/2009
6NDC:0135-0467-1425 in 1 CARTON; Type 0: Not a Combination Product06/29/200908/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006606/29/2009
NICORETTE FRESH MINT
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0225
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
ColorwhiteScoreno score
ShapeSQUARESize15mm
FlavorMINT (Fresh Mint) Imprint CodeN2
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0225-021 in 1 CARTON06/29/2009
1100 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0225-031 in 1 CARTON06/29/200908/01/2019
2190 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0225-0820 in 1 CARTON; Type 0: Not a Combination Product06/29/200908/01/2019
4NDC:0135-0225-1425 in 1 CARTON; Type 0: Not a Combination Product06/29/200908/01/2018
5NDC:0135-0225-158 in 1 PACKAGE06/29/200908/01/2018
525 in 1 CARTON; Type 0: Not a Combination Product
6NDC:0135-0225-172 in 1 PACKAGE08/01/2014
610 in 1 CARTON
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01861206/29/2009
NICORETTE FRESH MINT
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0226
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM CARBONATE (UNII: 45P3261C7T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
Colorwhite (light cream) Scoreno score
ShapeSQUARESize15mm
FlavorMINT (Fresh Mint) Imprint CodeN4
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0226-021 in 1 CARTON06/29/2009
1100 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0226-031 in 1 CARTON06/29/200908/01/2019
2190 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0226-0820 in 1 CARTON; Type 0: Not a Combination Product06/29/200908/01/2019
4NDC:0135-0226-1425 in 1 CARTON; Type 0: Not a Combination Product06/29/200908/01/2018
5NDC:0135-0226-158 in 1 PACKAGE06/29/200908/01/2018
525 in 1 CARTON; Type 0: Not a Combination Product
6NDC:0135-0226-172 in 1 PACKAGE08/01/2014
610 in 1 CARTON
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006606/29/2009
NICORETTE MINT
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0229
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
Colorbrown (beige) Scoreno score
ShapeSQUARESize14mm
FlavorMINTImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0229-031 in 1 CARTON06/29/200908/01/2019
150 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0229-041 in 1 CARTON06/29/200908/01/2019
2110 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0229-051 in 1 CARTON06/29/2009
3170 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01861206/29/2009
NICORETTE MINT
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0230
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM CARBONATE (UNII: 45P3261C7T)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
Colorbrown (beige) Scoreno score
ShapeSQUARESize14mm
FlavorMINTImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0230-031 in 1 CARTON06/29/2009
150 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0230-041 in 1 CARTON06/29/200908/01/2019
2110 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0230-051 in 1 CARTON06/29/2009
3170 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006606/29/2009
NICORETTE SPEARMINT BURST
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0532
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE2 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
Colorwhite (beige) Scoreno score
ShapeSQUARESize15mm
FlavorSPEARMINTImprint CodeN2
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0532-0210 in 1 CARTON09/13/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0532-0316 in 1 CARTON09/13/2017
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0532-122 in 1 PACKAGE03/01/2018
310 in 1 CARTON
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0135-0532-1312 in 1 CARTON09/01/2018
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:0135-0532-1418 in 1 CARTON12/03/2018
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01861209/13/2017
NICORETTE SPEARMINT BURST
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0533
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
ColoryellowScoreno score
ShapeSQUARESize15mm
FlavorSPEARMINTImprint CodeN4
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0533-0210 in 1 CARTON09/13/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0135-0533-122 in 1 PACKAGE03/01/2018
210 in 1 CARTON
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0135-0533-1312 in 1 CARTON09/01/2018
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:0135-0533-1418 in 1 CARTON12/03/2018
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006609/13/2017
NICORETTE SPEARMINT BURST
nicotine polacrilex gum, chewing
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0355
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NICOTINE (UNII: 6M3C89ZY6R) (NICOTINE - UNII:6M3C89ZY6R) NICOTINE4 mg
Inactive Ingredients
Ingredient NameStrength
POLACRILIN (UNII: RCZ785HI7S)
ACACIA (UNII: 5C5403N26O)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CARNAUBA WAX (UNII: R12CBM0EIZ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CARBONATE (UNII: 45P3261C7T)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
ColoryellowScoreno score
ShapeSQUARESize15mm
FlavorSPEARMINTImprint CodeN4
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0355-0316 in 1 CARTON09/13/2017
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02006609/13/2017
Labeler - Haleon US Holdings LLC (079944263)

Frequently asked questions