NDC 0121-0638

GUAIFENESIN DM

Guaifenesin And Dextromethorphan

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

Product ID0121-0638_4b481e49-7547-3345-e054-00144ff8d46c
NDC0121-0638
Product TypeHuman Otc Drug
Proprietary NameGUAIFENESIN DM
Generic NameGuaifenesin And Dextromethorphan
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date1992-07-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NamePharmaceutical Associates, Inc.
Substance NameGUAIFENESIN; DEXTROMETHORPHAN
Active Ingredient Strength100 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0121-0638-00

10 TRAY in 1 CASE (0121-0638-00) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0638-05)
Marketing Start Date1992-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-0638-00 [00121063800]

GUAIFENESIN DM SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1992-07-01

NDC 0121-0638-10 [00121063810]

GUAIFENESIN DM SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1992-07-01
Marketing End Date2017-03-28

NDC 0121-0638-04 [00121063804]

GUAIFENESIN DM SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date1992-07-01

NDC 0121-0638-05 [00121063805]

GUAIFENESIN DM SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date1992-07-01

NDC 0121-0638-16 [00121063816]

GUAIFENESIN DM SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date1992-07-01

NDC 0121-0638-08 [00121063808]

GUAIFENESIN DM SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date1992-07-01

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:ff970fff-d1a3-4322-83b4-34e361431a1c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996520
  • UPC Code
  • 0301210638169
  • 0301210638046
  • 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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