NDC 53809-201

DOMETUSS-DM

Guaifenesin, Dextromethorphan Hbr

DOMETUSS-DM is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Domel Laboratories. The primary component is Guaifenesin; Dextromethorphan Hydrobromide.

Product ID53809-201_140b4509-8eac-40c5-bffe-1aaed058a371
NDC53809-201
Product TypeHuman Otc Drug
Proprietary NameDOMETUSS-DM
Generic NameGuaifenesin, Dextromethorphan Hbr
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2016-01-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameDomel Laboratories
Substance NameGUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength200 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53809-201-01

30 mL in 1 BOTTLE (53809-201-01)
Marketing Start Date2016-01-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53809-201-04 [53809020104]

DOMETUSS-DM LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-01-21

NDC 53809-201-01 [53809020101]

DOMETUSS-DM LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-01-21

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN200 mg/5mL

NDC Crossover Matching brand name "DOMETUSS-DM" or generic name "Guaifenesin, Dextromethorphan Hbr"

NDCBrand NameGeneric Name
53809-201DOMETUSS-DMDOMETUSS-DM
47682-217Medique Guaicon DMSGuaifenesin, Dextromethorphan Hbr
0904-6233MUCUS RELIEF DMGUAIFENESIN, DEXTROMETHORPHAN HBr
11822-0733Mucus Relief DMGuaifenesin, Dextromethorphan HBr
11822-7340Mucus Relief DMGuaifenesin, Dextromethorphan HBr
21130-933Mucus Relief DMGuaifenesin, Dextromethorphan HBr
37012-729Mucus Relief DMGuaifenesin, Dextromethorphan HBr
49035-825Mucus Relief DMGuaifenesin, Dextromethorphan HBr
11673-833Mucus Relief DM Extended ReleaseGuaifenesin, Dextromethorphan HBr
0363-0437Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
0363-0733Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
0536-1161Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
0536-1213Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
37012-730Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
41250-633Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
41250-934Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
49035-824Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
50090-6020Mucus Relief DM Extended Release CapletsGuaifenesin, Dextromethorphan HBr
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