NDC 53113-557

Gadavyt Cough DM

Dextromethorphan Hydrobromide, Guaifenesin

Gadavyt Cough DM is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Gadal Laboratories Inc. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

Product ID53113-557_77ed1487-5de6-47c6-b4e1-abaf25512649
NDC53113-557
Product TypeHuman Otc Drug
Proprietary NameGadavyt Cough DM
Generic NameDextromethorphan Hydrobromide, Guaifenesin
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2012-12-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGadal Laboratories Inc
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active Ingredient Strength10 mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53113-557-04

118 mL in 1 BOTTLE (53113-557-04)
Marketing Start Date2012-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53113-557-04 [53113055704]

Gadavyt Cough DM LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-12-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL

OpenFDA Data

SPL SET ID:1906ab0e-42dc-4619-87a3-d7a30f432a95
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996520
    • UPC Code
  • 0854933105574

    • NDC Crossover Matching brand name "Gadavyt Cough DM" or generic name "Dextromethorphan Hydrobromide, Guaifenesin"

    NDCBrand NameGeneric Name
    53113-557Gadavyt Cough DMGadavyt Cough DM
    0363-1603adult tussin dmdextromethorphan hydrobromide, guaifenesin
    0280-0089Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizzdextromethorphan hydrobromide, guaifenesin
    0280-1660Alka-Seltzer Plus Maximum Strength Cough and Mucus DMDextromethorphan Hydrobromide, Guaifenesin
    0113-7419basic care mucus dmdextromethorphan hydrobromide, guaifenesin
    0536-1313Chest Congestion ReliefDextromethorphan Hydrobromide, Guaifenesin
    0904-7134Chest Congestion ReliefDextromethorphan Hydrobromide, Guaifenesin
    0904-7135Chest Congestion ReliefDextromethorphan Hydrobromide, Guaifenesin
    0031-8715Childrens Robitussin Cough and Chest Congestion DMdextromethorphan hydrobromide, guaifenesin
    0363-0419CoughDextromethorphan Hydrobromide, Guaifenesin
    0113-0419Good Sense Childrens Mucus Relief CoughDextromethorphan Hydrobromide, Guaifenesin
    0113-2219Good Sense Mucus DMdextromethorphan hydrobromide, guaifenesin
    0113-0359good sense tussin dmDextromethorphan Hydrobromide, Guaifenesin
    0113-1725good sense tussin dmdextromethorphan hydrobromide, guaifenesin
    0363-0505Mucus Relief DMdextromethorphan hydrobromide, guaifenesin
    0363-6812mucus relief dmdextromethorphan hydrobromide, guaifenesin
    0904-7223robafen dmdextromethorphan hydrobromide, guaifenesin
    0031-8765Robitussin Maximum Strength 12 Hour Cough and Mucus ReliefDextromethorphan Hydrobromide, Guaifenesin
    0031-8739ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DMdextromethorphan hydrobromide, guaifenesin
    0031-8759Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DMdextromethorphan hydrobromide, guaifenesin
    0536-1348rugby cough syrupdextromethorphan hydrobromide, guaifenesin
    0372-0050Scot-Tussin Senior SF DMEXPDextromethorphan Hydrobromide, Guaifenesin
    0067-8118TriaminicDextromethorphan Hydrobromide, Guaifenesin
    0363-1144tussin dm maxDextromethorphan Hydrobromide, Guaifenesin
    0904-5180Tussin Sugar Free CoughDextromethorphan Hydrobromide, GUAIFENESIN
    11673-235up and up maximum strength mucus relief dmdextromethorphan hydrobromide, guaifenesin
    0363-0359Wal TussinDextromethorphan Hydrobromide, Guaifenesin
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