NDC 0121-0809

Guaifenesin DM

Guaifenesin And Dextromethorphan

Guaifenesin DM is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Guaifenesin; Dextromethorphan.

Product ID0121-0809_58f894c7-263c-433a-af8d-7073c7079917
NDC0121-0809
Product TypeHuman Otc Drug
Proprietary NameGuaifenesin DM
Generic NameGuaifenesin And Dextromethorphan
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2010-05-17
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePharmaceutical Associates, Inc.
Substance NameGUAIFENESIN; DEXTROMETHORPHAN
Active Ingredient Strength200 mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0121-0809-04

118 mL in 1 BOTTLE (0121-0809-04)
Marketing Start Date2010-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-0809-08 [00121080908]

Guaifenesin DM SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-05-17
Inactivation Date2019-10-21

NDC 0121-0809-04 [00121080904]

Guaifenesin DM SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-05-17
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN200 mg/5mL

OpenFDA Data

SPL SET ID:990eef79-5380-48c6-8b8f-d4814e0fd293
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1046631
  • NDC Crossover Matching brand name "Guaifenesin DM" or generic name "Guaifenesin And Dextromethorphan"

    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 and DEXTROMETHORPHAN
    50090-3492GUAIFENESIN DMGUAIFENESIN and DEXTROMETHORPHAN
    55154-5783GUAIFENESIN DMGUAIFENESIN and DEXTROMETHORPHAN
    55154-5785GUAIFENESIN DMGUAIFENESIN and DEXTROMETHORPHAN
    66007-204Expectorant plus Cough ReliefGuaifenesin and Dextromethorphan
    69822-021MMM - Cough Formula Guaifenesin DMGuaifenesin DM

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