NDC 52083-400

ZYNCOF

Dextromethorphan Hbr And Guaifenesin

ZYNCOF is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID52083-400_0ce3d63e-43c0-43d9-a1ff-cb48da835eee
NDC52083-400
Product TypeHuman Otc Drug
Proprietary NameZYNCOF
Generic NameDextromethorphan Hbr And Guaifenesin
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2011-06-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameKramer Novis
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength20 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52083-400-01

30 mL in 1 BOTTLE, PLASTIC (52083-400-01)
Marketing Start Date2011-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-400-04 [52083040004]

ZYNCOF SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-06-01

NDC 52083-400-01 [52083040001]

ZYNCOF SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2011-06-01

NDC 52083-400-16 [52083040016]

ZYNCOF SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2013-01-23

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/5mL

OpenFDA Data

SPL SET ID:cffd6d5f-0cb2-4d38-bdb0-6a21120418cc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1113368
    • UPC Code
  • 0352083400049

    • NDC Crossover Matching brand name "ZYNCOF" or generic name "Dextromethorphan Hbr And Guaifenesin"

    NDCBrand NameGeneric Name
    52083-400ZYNCOFDextromethorphan HBr and Guaifenesin
    52083-410ZYNCOFDextromethorphan Hydrobromide, Guaifenesin
    50090-3251Dextromethorphan HBr and GuaifenesinDextromethorphan HBr and Guaifenesin
    50383-062Dextromethorphan HBr and GuaifenesinDextromethorphan HBr and Guaifenesin
    52083-600G-ZYNCOFDextromethorphan HBr and Guaifenesin
    41250-748Meijer Mucus Relief DMDextromethorphan HBr and Guaifenesin
    50844-733Mucus Relief CoughDextromethorphan HBr and Guaifenesin
    0363-7390Mucus Relief DMDextromethorphan HBr and Guaifenesin
    41250-533Mucus Relief DMDextromethorphan HBr and Guaifenesin
    55301-533Mucus Relief DMDextromethorphan HBr and Guaifenesin
    55319-533Mucus Relief DMDextromethorphan HBr and Guaifenesin
    67091-342Mucus Relief DMDextromethorphan HBr and Guaifenesin
    21695-737Q Tussin DMDextromethorphan HBr and Guaifenesin
    63187-040Q Tussin DMDextromethorphan HBr and Guaifenesin
    55758-013SanaTos Children Cough and Congestion CherryDEXTROMETHORPHAN HBr and GUAIFENESIN
    50066-806Tukol For DiabeticsDextromethorphan HBr and Guaifenesin
    37000-959Vicks JarabeDextromethorphan HBr and Guaifenesin
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.