NDC 53217-024

ROBAFEN COUGH FORMULA

Guaifenesin

ROBAFEN COUGH FORMULA is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Guaifenesin.

Product ID53217-024_0b3cb041-1d4b-486d-937b-95e06b0b9882
NDC53217-024
Product TypeHuman Otc Drug
Proprietary NameROBAFEN COUGH FORMULA
Generic NameGuaifenesin
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2012-08-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAidarex Pharmaceuticals LLC
Substance NameGUAIFENESIN
Active Ingredient Strength100 mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53217-024-01

118 mL in 1 BOTTLE, PLASTIC (53217-024-01)
Marketing Start Date2012-08-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-024-01 [53217002401]

ROBAFEN COUGH FORMULA SYRUP
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-08-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:a925e169-a63d-4614-925e-e556daef9ec5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310604
  • 213155

    • NDC Crossover Matching brand name "ROBAFEN COUGH FORMULA" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    68071-3020ROBAFEN COUGH FORMULAROBAFEN COUGH FORMULA
    50090-2711ROBAFEN COUGH FORMULAROBAFEN COUGH FORMULA
    53217-024ROBAFEN COUGH FORMULAROBAFEN COUGH FORMULA
    61786-963ROBAFEN COUGH FORMULAROBAFEN COUGH FORMULA
    0904-0061ROBAFEN COUGH FORMULAROBAFEN COUGH FORMULA
    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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