NDC 53113-550

Gadavyt Cough

Guaifenesin

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

Product ID53113-550_4ef93a86-4d13-4465-bcb2-08367c587b23
NDC53113-550
Product TypeHuman Otc Drug
Proprietary NameGadavyt Cough
Generic NameGuaifenesin
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2012-12-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGadal Laboratories Inc
Substance NameGUAIFENESIN
Active Ingredient Strength100 mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53113-550-04

118 mL in 1 BOTTLE (53113-550-04)
Marketing Start Date2012-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53113-550-04 [53113055004]

Gadavyt Cough 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
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:9af38fc3-f6d2-462f-8835-f69905e74610
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310604
  • UPC Code
  • 0854933105505
  • NDC Crossover Matching brand name "Gadavyt Cough" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    53113-550Gadavyt CoughGadavyt Cough
    0363-0288childrens chest congestionGuaifenesin
    0113-0325Good Sense Mucus ERGuaifenesin
    0113-2023good sense mucus erguaifenesin
    0113-3650Good Sense Mucus ERGuaifenesin
    0113-0061good sense tussinGuaifenesin
    0121-0744GUAIFENESINGUAIFENESIN
    0121-1488GUAIFENESINGUAIFENESIN
    0121-1744GUAIFENESINGUAIFENESIN
    0121-2232GUAIFENESINGUAIFENESIN
    0363-0028GuaifenesinGuaifenesin
    0363-0033GuaifenesinGuaifenesin
    0363-0071MucusGuaifenesin
    0363-0074MucusGuaifenesin
    0363-0532Mucus ReliefGuaifenesin
    0363-0325mucus relief erGuaifenesin
    0031-9303Robitussin Direct Chest Congestionguaifenesin
    0031-8724Robitussin Mucus Plus Chest CongestionGuaifenesin
    0113-2061tussinGuaifenesin
    0363-0310wal tussinGuaifenesin

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