NDC 53809-202

DOMETUSS

Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride

DOMETUSS is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Domel Laboratories. The primary component is Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID53809-202_00eadcd7-8bd0-4e6d-b8a5-6c9108b54233
NDC53809-202
Product TypeHuman Otc Drug
Proprietary NameDOMETUSS
Generic NameChlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2015-08-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameDomel Laboratories
Substance NameCHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength4 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53809-202-04

118 mL in 1 BOTTLE (53809-202-04)
Marketing Start Date2015-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53809-202-04 [53809020204]

DOMETUSS SYRUP
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-08-01

Drug Details

Active Ingredients

IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/5mL

NDC Crossover Matching brand name "DOMETUSS" or generic name "Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride"

NDCBrand NameGeneric Name
53809-202DOMETUSSchlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride
0485-0240ED-A-HIST DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
66576-240ED-A-HIST DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE
58605-103Maxichlor PEH DMCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

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