NDC 58809-945

TexaClear Kids Sinus Relief

Phenylephrine Hcl Thonzylamine Hcl

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

Product ID58809-945_65104cd2-b45a-4875-81cc-238df47453f1
NDC58809-945
Product TypeHuman Otc Drug
Proprietary NameTexaClear Kids Sinus Relief
Generic NamePhenylephrine Hcl Thonzylamine 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 NameTHONZYLAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength50 mg/30mL; mg/30mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58809-945-08

237 mL in 1 BOTTLE (58809-945-08)
Marketing Start Date2015-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-945-08 [58809094508]

TexaClear Kids Sinus Relief LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-06-15
Marketing End Date2019-01-16

Drug Details

Active Ingredients

IngredientStrength
THONZYLAMINE HYDROCHLORIDE50 mg/30mL

OpenFDA Data

SPL SET ID:3bc896f1-f10d-51b1-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1808194

  • © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.