NDC 53809-205

DOMETUSS-G

Acetaminophen, Guaifenesin, Dextromethrphan Hbr, Phenylephrine Hcl

DOMETUSS-G is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Domel Laboratories. The primary component is Acetaminophen; Guaifenesin; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

Product ID53809-205_1c9a5642-abec-42d6-af50-2735d893b423
NDC53809-205
Product TypeHuman Otc Drug
Proprietary NameDOMETUSS-G
Generic NameAcetaminophen, Guaifenesin, Dextromethrphan Hbr, Phenylephrine Hcl
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-01-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameDomel Laboratories
Substance NameACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53809-205-04

4 TABLET in 1 PACKAGE (53809-205-04)
Marketing Start Date2016-01-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53809-205-04 [53809020504]

DOMETUSS-G TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-01-21
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:7e947e5e-3646-44f7-8e6b-ac539fcbf7bf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1098435
  • NDC Crossover Matching brand name "DOMETUSS-G" or generic name "Acetaminophen, Guaifenesin, Dextromethrphan Hbr, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    53809-205DOMETUSS-GACETAMINOPHEN, GUAIFENESIN, DEXTROMETHRPHAN HBr, PHENYLEPHRINE HCL
    53809-250DOMETUSS-GGUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, and PHENYLEPHRINE HYDROCHLORIDE

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