Label: NICORETTE WHITE ICE MINT- nicotine polacrilex gum, chewing
NICORETTE ORIGINAL- nicotine polacrilex gum, chewing
NICORETTE CINNAMON SURGE- nicotine polacrilex gum, chewing
NICORETTE FRESH MINT- nicotine polacrilex gum, chewing
NICORETTE MINT- nicotine polacrilex gum, chewing
NICORETTE SPEARMINT BURST- nicotine polacrilex gum, chewing

  • NDC Code(s): 0135-0157-07, 0135-0157-10, 0135-0157-11, 0135-0157-12, view more
    0135-0158-07, 0135-0158-10, 0135-0158-11, 0135-0158-12, 0135-0225-02, 0135-0225-03, 0135-0225-08, 0135-0225-14, 0135-0225-15, 0135-0225-17, 0135-0226-02, 0135-0226-03, 0135-0226-08, 0135-0226-14, 0135-0226-15, 0135-0226-17, 0135-0229-03, 0135-0229-04, 0135-0229-05, 0135-0230-03, 0135-0230-04, 0135-0230-05, 0135-0355-03, 0135-0466-01, 0135-0466-02, 0135-0466-03, 0135-0466-05, 0135-0466-07, 0135-0466-08, 0135-0466-14, 0135-0467-01, 0135-0467-02, 0135-0467-05, 0135-0467-07, 0135-0467-08, 0135-0467-14, 0135-0474-01, 0135-0474-02, 0135-0474-05, 0135-0474-08, 0135-0474-14, 0135-0474-15, 0135-0474-17, 0135-0474-18, 0135-0474-19, 0135-0474-20, 0135-0475-01, 0135-0475-02, 0135-0475-03, 0135-0475-05, 0135-0475-08, 0135-0475-14, 0135-0475-15, 0135-0475-17, 0135-0475-18, 0135-0475-19, 0135-0475-20, 0135-0532-02, 0135-0532-03, 0135-0532-12, 0135-0532-13, 0135-0532-14, 0135-0533-02, 0135-0533-12, 0135-0533-13, 0135-0533-14
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 16, 2020

If you are a consumer or patient please visit this version.

  • Active ingredient (in each chewing piece)

    Nicotine polacrilex (equal to 2 mg nicotine)

    Nicotine polacrilex (equal to 4 mg nicotine)

  • Purpose

    Stop smoking aid

  • Use

    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.

  • Directions (2 mg)

    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.
  • Directions (4 mg)

    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 - 25oC (68 - 77oF)
    protect from light
  • Other information (Original)

    each piece contains: calcium 117 mg, sodium 13 mg
    store at 20 - 25oC (68 - 77oF)
    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 - 25oC (68 - 77oF)
    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 - 25oC (68 - 77oF)
    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 - 25oC (68 - 77oF)
    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 - 25oC (68 - 77oF)
    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 pieces of 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 program as 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

    GSK Consumer Healthcare

    Warren, NJ 07059

    Made in Sweden

    For more information and for a FREE individualized stop smoking program, please visit www.Nicorette.com or 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 WITHIN 30 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 THAN 30 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 WITHIN 30 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 THAN 30 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 WITHIN 30 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 THAN 30 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 MintTM

    2 mg

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

    If you smoke your first cigarette WITHIN 30 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 MintTM

    4 mg

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

    If you smoke your first cigarette MORE THAN 30 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 WITHIN 30 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 THAN 30 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 mg stop smoking aid

    Gum

    NEW FLAVOR

    Coated FOR BOLD FLAVOR

    Spearmint Burst with a hint of chamomile

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

    If you smoke your first cigarette WITHIN 30 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 Burst with a hint of chamomile

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

    If you smoke your first cigarette MORE THAN 30 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 Burst with a hint of chamomile

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

    If you smoke your first cigarette MORE THAN 30 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
  • INGREDIENTS AND APPEARANCE
    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 Code N2
    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 Code N4
    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 Code N2
    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 Code N4
    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 Code N2
    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 Code N4
    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 Code N2
    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 Code N4
    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 Code N4
    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 - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)