NDC 58809-514

NITECLEAR COLD AND FLU RELIEF

Choline Salicylate, Diphenhydramine Hci, Phenylephrine Hcl

NITECLEAR COLD AND FLU RELIEF is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Gm Pharmaceuticals, Inc. The primary component is Choline Salicylate; Diphenhydramine Hydrochloride; Phenylephrine Hydrochloride.

Product ID58809-514_d6468dfb-5d96-4770-8445-aa5528cba460
NDC58809-514
Product TypeHuman Otc Drug
Proprietary NameNITECLEAR COLD AND FLU RELIEF
Generic NameCholine Salicylate, Diphenhydramine Hci, Phenylephrine Hcl
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-10-20
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGM Pharmaceuticals, INC
Substance NameCHOLINE SALICYLATE; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength870 mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 58809-514-80

237 mL in 1 BOTTLE (58809-514-80)
Marketing Start Date2015-10-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58809-514-80 [58809051480]

NITECLEAR COLD AND FLU RELIEF SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-10-20
Marketing End Date2019-04-26

Drug Details

Active Ingredients

IngredientStrength
CHOLINE SALICYLATE870 mg/mL

OpenFDA Data

SPL SET ID:8c5588a7-155e-4a58-b4d3-da8ca36eee39
Manufacturer
UNII
UPC Code
  • 0358809514083

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