NDC 58809-346

TEXACLEAR CONGESTION AND PAIN SINUS RELIEF

Choline Salicylate,guaifenesin, Phenylephrine Hydrochloride

TEXACLEAR CONGESTION AND PAIN 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 Guaifenesin; Choline Salicylate; Phenylephrine Hydrochloride.

Product ID58809-346_8531377f-4864-492f-8372-cac44d9ca1d0
NDC58809-346
Product TypeHuman Otc Drug
Proprietary NameTEXACLEAR CONGESTION AND PAIN SINUS RELIEF
Generic NameCholine Salicylate,guaifenesin, Phenylephrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2014-10-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGM Pharmaceuticals, INC
Substance NameGUAIFENESIN; CHOLINE SALICYLATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength200 mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 58809-346-08

237 mL in 1 BOTTLE, PLASTIC (58809-346-08)
Marketing Start Date2014-10-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-346-08 [58809034608]

TEXACLEAR CONGESTION AND PAIN SINUS RELIEF LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-10-21

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN200 mg/30mL

OpenFDA Data

SPL SET ID:178f648e-9539-71b9-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1653155

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