NDC 0135-0533

Nicorette Spearmint Burst

Nicotine Polacrilex

Nicorette Spearmint Burst is a Oral Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Nicotine.

Product ID0135-0533_1107242e-6fb9-48c7-a01a-f299b1c90177
NDC0135-0533
Product TypeHuman Otc Drug
Proprietary NameNicorette Spearmint Burst
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationORAL
Marketing Start Date2017-09-13
Marketing CategoryNDA / NDA
Application NumberNDA020066
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NameNICOTINE
Active Ingredient Strength4 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0135-0533-02

10 BLISTER PACK in 1 CARTON (0135-0533-02) > 10 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2017-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0135-0533-12 [00135053312]

Nicorette Spearmint Burst GUM, CHEWING
Marketing CategoryNDA
Application NumberNDA020066
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-03-01
Inactivation Date2020-01-31

NDC 0135-0533-09 [00135053309]

Nicorette Spearmint Burst GUM, CHEWING
Marketing CategoryNDA
Application NumberNDA020066
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-13
Marketing End Date2014-11-21

NDC 0135-0533-14 [00135053314]

Nicorette Spearmint Burst GUM, CHEWING
Marketing CategoryNDA
Application NumberNDA020066
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-03
Inactivation Date2020-01-31

NDC 0135-0533-03 [00135053303]

Nicorette Spearmint Burst GUM, CHEWING
Marketing CategoryNDA
Application NumberNDA020066
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-13
Marketing End Date2014-11-21

NDC 0135-0533-04 [00135053304]

Nicorette Spearmint Burst GUM, CHEWING
Marketing CategoryNDA
Application NumberNDA020066
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-13
Marketing End Date2014-11-21

NDC 0135-0533-01 [00135053301]

Nicorette Spearmint Burst GUM, CHEWING
Marketing CategoryNDA
Application NumberNDA020066
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-13
Marketing End Date2014-11-21

NDC 0135-0533-10 [00135053310]

Nicorette Spearmint Burst GUM, CHEWING
Marketing CategoryNDA
Application NumberNDA020066
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-13
Marketing End Date2014-11-21

NDC 0135-0533-11 [00135053311]

Nicorette Spearmint Burst GUM, CHEWING
Marketing CategoryNDA
Application NumberNDA020066
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-13
Marketing End Date2014-11-21

NDC 0135-0533-13 [00135053313]

Nicorette Spearmint Burst GUM, CHEWING
Marketing CategoryNDA
Application NumberNDA020066
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-01
Inactivation Date2020-01-31

NDC 0135-0533-02 [00135053302]

Nicorette Spearmint Burst GUM, CHEWING
Marketing CategoryNDA
Application NumberNDA020066
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-09-13
Inactivation Date2020-01-31

NDC 0135-0533-08 [00135053308]

Nicorette Spearmint Burst GUM, CHEWING
Marketing CategoryNDA
Application NumberNDA020066
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-13
Marketing End Date2014-11-21

NDC 0135-0533-05 [00135053305]

Nicorette Spearmint Burst GUM, CHEWING
Marketing CategoryNDA
Application NumberNDA020066
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-13
Marketing End Date2014-11-21

Drug Details

Active Ingredients

IngredientStrength
NICOTINE4 mg/1

OpenFDA Data

SPL SET ID:673fd19f-69b3-4f73-b9b4-18b5f4cbf69c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311975
  • 209326
  • 314119
  • 105071

    • NDC Crossover Matching brand name "Nicorette Spearmint Burst" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    0135-0533Nicorette Spearmint BurstNicorette Spearmint Burst
    0135-0355Nicorette Spearmint BurstNicorette Spearmint Burst
    0135-0532Nicorette Spearmint BurstNicorette Spearmint Burst
    0113-0704basic care nicotineNicotine polacrilex
    0113-0713basic care nicotineNicotine Polacrilex
    0113-0749basic care nicotineNicotine Polacrilex
    0113-0761basic care nicotineNicotine Polacrilex
    0113-7007basic care nicotineNicotine Polacrilex
    0113-7008basic care nicotinenicotine polacrilex
    0113-7029basic care nicotineNicotine Polacrilex
    0113-0029Good Sense NicotineNicotine Polacrilex
    0113-0053Good Sense NicotineNicotine Polacrilex
    0113-0170Good Sense NicotineNicotine Polacrilex
    0113-0206good sense nicotineNicotine Polacrilex
    0113-0344Good Sense NicotineNicotine Polacrilex
    0113-0422Good Sense NicotineNicotine Polacrilex
    0113-0456Good Sense NicotineNicotine Polacrilex
    0113-0532Good Sense NicotineNicotine Polacrilex
    0113-0734Good Sense NicotineNicotine Polacrilex
    0113-0854Good Sense NicotineNicotine polacrilex
    0113-0873good sense nicotineNicotine Polacrilex
    0113-0957Good Sense NicotineNicotine Polacrilex
    0113-1125Good Sense NicotineNicotine Polacrilex
    0113-1190good sense nicotineNicotine Polacrilex
    0113-1352good sense nicotineNicotine Polacrilex
    0113-6000Tru Relief NicotineNicotine Polacrilex
    0113-6001Tru Relief NicotineNicotine Polacrilex

    Trademark Results [Nicorette]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NICORETTE
    NICORETTE
    97148669 not registered Live/Pending
    GlaxoSmithKline Consumer Healthcare, L.P.
    2021-11-30
    NICORETTE
    NICORETTE
    97148654 not registered Live/Pending
    GlaxoSmithKline Consumer Healthcare, L.P.
    2021-11-30
    NICORETTE
    NICORETTE
    97076449 not registered Live/Pending
    GlaxoSmithKline Consumer Healthcare, L.P.
    2021-10-15
    NICORETTE
    NICORETTE
    78026844 2670277 Dead/Cancelled
    GLAXOSMITHKLINE CONSUMER HEALTHCARE L.P.
    2000-09-20
    NICORETTE
    NICORETTE
    77006854 3509141 Live/Registered
    GlaxoSmithKline Consumer Healthcare L.P.
    2006-09-25
    NICORETTE
    NICORETTE
    75185006 2103431 Dead/Cancelled
    SmithKline Beecham Consumer Healthcare,L.P.
    1996-10-17
    NICORETTE
    NICORETTE
    75185005 2103430 Dead/Cancelled
    SmithKline Beecham Consumer Healthcare,L.P.
    1996-10-17
    NICORETTE
    NICORETTE
    73264072 1186363 Live/Registered
    AB Leo
    1980-05-29
    NICORETTE
    NICORETTE
    72464064 0992648 Live/Registered
    WARNER-LAMBERT COMPANY
    1973-07-27
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