NDC 11716-0460

SHOPKO RELIEF

Tetrahydrozoline Hydrochloride And Zinc Sulfate

SHOPKO RELIEF is a Ophthalmic Solution in the Human Otc Drug category. It is labeled and distributed by Hanlim Pharm. Co., Ltd.. The primary component is Tetrahydrozoline Hydrochloride; Zinc Sulfate.

Product ID11716-0460_505ed84a-9943-43b3-9240-f47cb0a6ea3c
NDC11716-0460
Product TypeHuman Otc Drug
Proprietary NameSHOPKO RELIEF
Generic NameTetrahydrozoline Hydrochloride And Zinc Sulfate
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2010-10-08
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart349
Labeler NameHANLIM PHARM. CO., LTD.
Substance NameTETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE
Active Ingredient Strength1 mg/mL; mg/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 11716-0460-1

1 BOTTLE in 1 CARTON (11716-0460-1) > 15 mL in 1 BOTTLE
Marketing Start Date2010-10-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11716-0460-1 [11716046001]

SHOPKO RELIEF SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-10-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE.5 mg/mL

OpenFDA Data

SPL SET ID:4c732e9c-4d64-4deb-83d9-ffeb5da72c26
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043249
  • UPC Code
  • 0400390046013
  • NDC Crossover Matching brand name "SHOPKO RELIEF" or generic name "Tetrahydrozoline Hydrochloride And Zinc Sulfate"

    NDCBrand NameGeneric Name
    11716-0460SHOPKO RELIEFTETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE
    55319-323FAMILY WELLNESS IRRITATION RELIEF AC EYE DROPSTETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE
    11716-9638LEADER RELIEFTETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE
    11716-0103PREMIER VALUE EYE ACTETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE
    42002-201Visine A.C.Tetrahydrozoline Hydrochloride and Zinc Sulfate

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