NDC 0904-6309

Robafen CF Cough and cold

Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

Robafen CF Cough and cold is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Guaifenesin; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID0904-6309_f9196370-2776-452e-bc5d-41bb4f6fcc7f
NDC0904-6309
Product TypeHuman Otc Drug
Proprietary NameRobafen CF Cough and cold
Generic NameGuaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2013-03-05
Marketing End Date2019-04-29
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMajor Pharmaceuticals
Substance NameGUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength100 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN

Packaging

NDC 0904-6309-20

1 BOTTLE in 1 CARTON (0904-6309-20) > 118 mL in 1 BOTTLE
Marketing Start Date2013-03-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6309-20 [00904630920]

Robafen CF Cough and cold SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2013-03-05
Marketing End Date2019-04-29

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:22bc53c2-e4b4-4821-b80d-8a783d77836a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1044949
  • NDC Crossover Matching brand name "Robafen CF Cough and cold" or generic name "Guaifenesin, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0904-6309Robafen CF Cough and coldGuaifenesin, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
    53809-250DOMETUSS-GGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    43913-403G-BRONCO-DGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
    75834-040Nivanex DMXGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

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