NDC 0904-5735

nicorelief

Nicotine Polacrilex

nicorelief is a Oral Gum, Chewing in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Nicotine.

Product ID0904-5735_1987b26a-a301-4550-81fb-85338127e281
NDC0904-5735
Product TypeHuman Otc Drug
Proprietary Namenicorelief
Generic NameNicotine Polacrilex
Dosage FormGum, Chewing
Route of AdministrationORAL
Marketing Start Date2005-04-12
Marketing End Date2019-11-30
Marketing CategoryANDA / ANDA
Application NumberANDA076789
Labeler NameMajor Pharmaceuticals
Substance NameNICOTINE
Active Ingredient Strength4 mg/1
NDC Exclude FlagN

Packaging

NDC 0904-5735-11

110 BLISTER PACK in 1 CARTON (0904-5735-11) > 1 GUM, CHEWING in 1 BLISTER PACK
Marketing Start Date2005-04-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-5735-51 [00904573551]

nicorelief GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076789
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2005-04-12
Marketing End Date2019-10-31

NDC 0904-5735-11 [00904573511]

nicorelief GUM, CHEWING
Marketing CategoryANDA
Application NumberANDA076789
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2005-04-12
Marketing End Date2019-11-30

Drug Details

Active Ingredients

IngredientStrength
NICOTINE4 mg/1

OpenFDA Data

SPL SET ID:e76395e1-0e30-4004-8287-a389b46625bf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311975
  • 605820

    • NDC Crossover Matching brand name "nicorelief" or generic name "Nicotine Polacrilex"

    NDCBrand NameGeneric Name
    0904-5734nicoreliefnicorelief
    0904-5737NicoreliefNicorelief
    0904-5736NicoreliefNicorelief
    0904-5735nicoreliefnicorelief
    17856-5734NicoreliefNicorelief
    17856-5736NicoreliefNicorelief
    50090-1145NicoreliefNicorelief
    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 [nicorelief]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NICORELIEF
    NICORELIEF
    78516195 3189960 Live/Registered
    Harvard Drug Group, LLC
    2004-11-12
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.