NDC 0904-0053

Rabofen DM

Guaifenesin And Dextromethorphan Hydrobromide

Rabofen DM 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.

Product ID0904-0053_7f71b64b-801d-2d1f-e053-2991aa0a4dc7
NDC0904-0053
Product TypeHuman Otc Drug
Proprietary NameRabofen DM
Generic NameGuaifenesin And Dextromethorphan Hydrobromide
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2004-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameMajor Pharmaceuticals
Substance NameGUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength100 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-0053-16

473 mL in 1 BOTTLE (0904-0053-16)
Marketing Start Date2004-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-0053-20 [00904005320]

Rabofen DM SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2009-01-07
Marketing End Date2016-10-20

NDC 0904-0053-09 [00904005309]

Rabofen DM SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2004-01-01
Marketing End Date2020-08-31

NDC 0904-0053-00 [00904005300]

Rabofen DM SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2004-01-01
Marketing End Date2021-01-31

NDC 0904-0053-16 [00904005316]

Rabofen DM SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2004-01-01
Marketing End Date2020-10-31

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:5d52a150-6793-469f-bace-596ee91b2045
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1245454
  • 996520

    • NDC Crossover Matching brand name "Rabofen DM" or generic name "Guaifenesin And Dextromethorphan Hydrobromide"

    NDCBrand NameGeneric Name
    0904-0053Rabofen DMGuaifenesin and Dextromethorphan Hydrobromide
    68071-4143Rabofen DMRabofen DM
    68788-0841Rabofen DMRabofen DM
    50090-2657Rabofen DMRabofen DM
    0536-0970Extra action CoughGuaifenesin and DEXTROMETHORPHAN HYDROBROMIDE
    48433-221GUAIFENESIN AND DEXTROMETHORPHAN HBrguaifenesin and dextromethorphan hydrobromide
    0363-0076Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    11822-7156Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    24451-133Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    24689-123Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    30142-706Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    49035-077Guaifenesin and Dextromethorphan HydrobromideGuaifenesin and Dextromethorphan Hydrobromide
    11822-9996Guaifenesin and Dextromethorphan Hydrobromide HBRguaifenesin and dextromethorphan hydrobromide
    43063-801Guaifenesin DMGuaifenesin and Dextromethorphan Hydrobromide
    17856-0056Mucinex DMGuaifenesin and Dextromethorphan Hydrobromide
    50090-1077Mucinex DMGuaifenesin and Dextromethorphan Hydrobromide
    50090-1078Mucinex DMGuaifenesin and Dextromethorphan Hydrobromide
    50090-2298Mucinex DMGuaifenesin and Dextromethorphan Hydrobromide
    0363-9013MUCUS RELIEF DMGUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE
    0363-9891MUCUS RELIEF DMGUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE
    0363-9897MUCUS RELIEF DMGUAIFENESIN and DEXTROMETHORPHAN HYDROBROMIDE
    30142-991Mucus Relief ER DMGuaifenesin and Dextromethorphan Hydrobromide
    0904-6306Robafen DM Cough Sugar Free ClearGuaifenesin and Dextromethorphan Hydrobromide
    17856-6306Robafen DM Cough Sugar Free ClearGuaifenesin and Dextromethorphan Hydrobromide
    17856-0134Siltussin DM DAS Cough FormulaGuaifenesin and Dextromethorphan Hydrobromide
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