NDC 52083-646

DESGEN DM

Dextromethorphan Hbr ,guaifenesin ,phenylephrine Hcl

DESGEN DM is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID52083-646_44763d19-83b8-4748-96b6-6e0b286c972e
NDC52083-646
Product TypeHuman Otc Drug
Proprietary NameDESGEN DM
Generic NameDextromethorphan Hbr ,guaifenesin ,phenylephrine Hcl
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2014-10-18
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameKramer Novis
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52083-646-16

474 mL in 1 BOTTLE (52083-646-16)
Marketing Start Date2014-10-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52083-646-16 [52083064616]

DESGEN DM SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-10-18

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL

OpenFDA Data

SPL SET ID:6ab47174-e1fd-47ce-8788-06b7cdad5218
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1044949

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