NDC 58809-950

TexaClear Kids Cough and Cold

Dextromethorphan Hbr Guaifenesin Phenyephrine Hcl

TexaClear Kids Cough and Cold is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Gm Pharmaceuticals, Inc. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID58809-950_7eb896f4-1003-4c8f-a639-44dfdf064962
NDC58809-950
Product TypeHuman Otc Drug
Proprietary NameTexaClear Kids Cough and Cold
Generic NameDextromethorphan Hbr Guaifenesin Phenyephrine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2015-06-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGM Pharmaceuticals, INC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 58809-950-08

237 mL in 1 BOTTLE (58809-950-08)
Marketing Start Date2015-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-950-08 [58809095008]

TexaClear Kids Cough and Cold LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-06-15

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/30mL

OpenFDA Data

SPL SET ID:3bc591c6-2f94-5cbe-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1808192
  • UPC Code
  • 0358809950089

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