NDC 58809-372

TEXACLEAR NIGHT TIME COUGH COLD/FLU

Choline Salicylate, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

TEXACLEAR NIGHT TIME COUGH COLD/FLU is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Gm Pharmaceuticals, Inc. The primary component is Choline Salicylate; Phenylephrine Hydrochloride; Diphenhydramine Hydrochloride.

Product ID58809-372_acd9df38-fe82-4172-9580-9d15f67b32c4
NDC58809-372
Product TypeHuman Otc Drug
Proprietary NameTEXACLEAR NIGHT TIME COUGH COLD/FLU
Generic NameCholine Salicylate, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2014-10-23
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGM Pharmaceuticals, INC
Substance NameCHOLINE SALICYLATE; PHENYLEPHRINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength870 mg/30mL; mg/30mL; mg/30mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 58809-372-08

237 mL in 1 BOTTLE, PLASTIC (58809-372-08)
Marketing Start Date2014-10-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-372-08 [58809037208]

TEXACLEAR NIGHT TIME COUGH COLD/FLU LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-10-23

Drug Details

Active Ingredients

IngredientStrength
CHOLINE SALICYLATE870 mg/30mL

OpenFDA Data

SPL SET ID:17a39de8-1702-0711-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1653139
  • NDC Crossover Matching brand name "TEXACLEAR NIGHT TIME COUGH COLD/FLU" or generic name "Choline Salicylate, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    58809-372TEXACLEAR NIGHT TIME COUGH COLD/FLUCholine Salicylate, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride
    30142-772Kroger NiteTime Cold and FluCholine Salicylate, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride

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