NDC 58809-390

TEXACLEAR PM PAIN RELIEVER SLEEP AID

Choline Salicylate, Diphenhydramine Hcl

TEXACLEAR PM PAIN RELIEVER SLEEP AID 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; Diphenhydramine Hydrochloride.

Product ID58809-390_0eda501a-35c5-415d-98a0-9cc21fefa987
NDC58809-390
Product TypeHuman Otc Drug
Proprietary NameTEXACLEAR PM PAIN RELIEVER SLEEP AID
Generic NameCholine Salicylate, Diphenhydramine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2017-03-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGM Pharmaceuticals, INC
Substance NameCHOLINE SALICYLATE; DIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength870 mg/mL; mg/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 58809-390-08

237 mL in 1 BOTTLE (58809-390-08)
Marketing Start Date2017-03-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-390-08 [58809039008]

TEXACLEAR PM PAIN RELIEVER SLEEP AID LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-15
Marketing End Date2019-04-04

Drug Details

Active Ingredients

IngredientStrength
CHOLINE SALICYLATE870 mg/mL

OpenFDA Data

SPL SET ID:761c6205-8150-469b-b250-9b4e39940c60
Manufacturer
UNII
UPC Code
  • 0358809390083

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