NDC 43063-801

Guaifenesin DM

Guaifenesin And Dextromethorphan Hydrobromide

Guaifenesin DM is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Guaifenesin; Dextromethorphan Hydrobromide.

Product ID43063-801_763ce792-c999-f472-e053-2a91aa0a77dd
NDC43063-801
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin DM
Generic NameGuaifenesin And Dextromethorphan Hydrobromide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-11-14
Marketing End Date2027-11-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NameGUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength400 mg/1; mg/1
NDC Exclude FlagN

Packaging

NDC 43063-801-60

60 TABLET in 1 BOTTLE, PLASTIC (43063-801-60)
Marketing Start Date2017-11-14
Marketing End Date2027-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-801-60 [43063080160]

Guaifenesin DM TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-11-14
Marketing End Date2027-11-30

NDC 43063-801-90 [43063080190]

Guaifenesin DM TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2017-11-14
Marketing End Date2027-11-30

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN400 mg/1

OpenFDA Data

SPL SET ID:ac8c0c15-b305-47f2-8712-e4b53636f7fa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1147685

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

    NDCBrand NameGeneric Name
    0121-0638GUAIFENESIN DMGUAIFENESIN and DEXTROMETHORPHAN
    0121-0809Guaifenesin DMGUAIFENESIN and DEXTROMETHORPHAN
    0121-1276GUAIFENESIN DMGUAIFENESIN and DEXTROMETHORPHAN
    0121-4809Guaifenesin DMGUAIFENESIN and DEXTROMETHORPHAN
    43063-801Guaifenesin DMGuaifenesin and Dextromethorphan Hydrobromide
    50090-2303GUAIFENESIN DMGUAIFENESIN DM
    50090-3492GUAIFENESIN DMGUAIFENESIN DM
    55154-5785GUAIFENESIN DMGUAIFENESIN DM
    55154-5783GUAIFENESIN DMGUAIFENESIN 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
    17856-0056Mucinex 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
    0904-0053Rabofen 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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