NDC 58809-925

TexaClear Kids Allergy

Chlophedianol Hcl Pyrilamine Maleate

TexaClear Kids Allergy is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Gm Pharmaceuticals, Inc. The primary component is Chlophedianol Hydrochloride; Pyrilamine Maleate.

Product ID58809-925_126d9b63-4ff4-46dc-a3b5-5cfee551c65c
NDC58809-925
Product TypeHuman Otc Drug
Proprietary NameTexaClear Kids Allergy
Generic NameChlophedianol Hcl Pyrilamine Maleate
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2016-06-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGM Pharmaceuticals, INC
Substance NameCHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE
Active Ingredient Strength13 mg/30mL; mg/30mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 58809-925-08

237 mL in 1 BOTTLE (58809-925-08)
Marketing Start Date2016-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-925-08 [58809092508]

TexaClear Kids Allergy LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-06-15

Drug Details

Active Ingredients

IngredientStrength
CHLOPHEDIANOL HYDROCHLORIDE12.5 mg/30mL

OpenFDA Data

SPL SET ID:3b8a686f-d8e8-56db-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1808189
  • UPC Code
  • 0358809925087

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