NDC 53809-203

DOMETUSS-DMX

Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl

DOMETUSS-DMX 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; Phenylephrine Hydrochloride.

Product ID53809-203_23161838-5b4c-42c1-b8b6-653d26334fda
NDC53809-203
Product TypeHuman Otc Drug
Proprietary NameDOMETUSS-DMX
Generic NameGuaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl
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; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength200 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53809-203-01

30 mL in 1 BOTTLE (53809-203-01)
Marketing Start Date2016-01-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53809-203-16 [53809020316]

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

NDC 53809-203-04 [53809020304]

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

NDC 53809-203-01 [53809020301]

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

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN200 mg/5mL

OpenFDA Data

SPL SET ID:6949e1c6-df1c-451b-a1e2-9199415440f4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1364914

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