NDC 55154-5785

GUAIFENESIN DM

Guaifenesin And Dextromethorphan

GUAIFENESIN DM is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Cardinal Health 107, Llc. The primary component is Dextromethorphan; Guaifenesin.

Product ID55154-5785_0dabaf9b-0871-43ef-9654-bd279ae7670a
NDC55154-5785
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 NameCardinal Health 107, LLC
Substance NameDEXTROMETHORPHAN; GUAIFENESIN
Active Ingredient Strength10 mg/5mL; mg/5mL
Pharm ClassesDecreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 55154-5785-5

5 CUP, UNIT-DOSE in 1 BAG (55154-5785-5) > 5 mL in 1 CUP, UNIT-DOSE
Marketing Start Date1992-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55154-5785-5 [55154578505]

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

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.