NDC 58809-955

TexaClear Kids Cold Relief

Diphenhydramine Hcl Phenylephrine Hcl

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

Product ID58809-955_21da8674-dfbf-486b-a608-2644650f4320
NDC58809-955
Product TypeHuman Otc Drug
Proprietary NameTexaClear Kids Cold Relief
Generic NameDiphenhydramine Hcl Phenylephrine 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 NameDIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength25 mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58809-955-08

237 mL in 1 BOTTLE (58809-955-08)
Marketing Start Date2015-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-955-08 [58809095508]

TexaClear Kids Cold Relief LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-06-15
Marketing End Date2019-04-30

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/30mL

OpenFDA Data

SPL SET ID:3bde7a0e-22c4-5fcb-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1809636
  • UPC Code
  • 0358809955084

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