NDC 11716-0101

PREMIER VALUE ORIGINAL

Tetrahydrozoline Hydrochloride

PREMIER VALUE ORIGINAL 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.

Product ID11716-0101_2383b6cc-a845-4599-b785-d35391f88cbf
NDC11716-0101
Product TypeHuman Otc Drug
Proprietary NamePREMIER VALUE ORIGINAL
Generic NameTetrahydrozoline Hydrochloride
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-05-19
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart349
Labeler NameHANLIM PHARM. CO., LTD.
Substance NameTETRAHYDROZOLINE HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 11716-0101-1

1 BOTTLE in 1 CARTON (11716-0101-1) > 15 mL in 1 BOTTLE
Marketing Start Date2014-05-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11716-0101-1 [11716010101]

PREMIER VALUE ORIGINAL SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart349
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-05-19
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE.5 mg/mL

OpenFDA Data

SPL SET ID:b75edf79-0bde-46f4-a1d0-ba1b44eb56c4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1052943
    • UPC Code
  • 0840986010118

    • NDC Crossover Matching brand name "PREMIER VALUE ORIGINAL" or generic name "Tetrahydrozoline Hydrochloride"

    NDCBrand NameGeneric Name
    11716-0101PREMIER VALUE ORIGINALTETRAHYDROZOLINE HYDROCHLORIDE
    68016-448Premier Value OriginalTetrahydrozoline Hydrochloride
    33992-9376ASSURED ORIGINAL RELIEF EYETETRAHYDROZOLINE HYDROCHLORIDE
    66715-5729Circle K Eye DropsTetrahydrozoline Hydrochloride
    59779-741CVS Redness Relief OriginalTetrahydrozoline hydrochloride
    11716-0053DG HEALTH ORIGINALTETRAHYDROZOLINE HYDROCHLORIDE
    55910-641DG Health Sterile Redness ReliefTETRAHYDROZOLINE HYDROCHLORIDE
    79903-010Equate Redness Relievertetrahydrozoline hydrochloride
    0498-0161Eye DropsTetrahydrozoline hydrochloride
    55651-005Eye Drops Regulartetrahydrozoline hydrochloride
    62011-0102Eye Drops Regulartetrahydrozoline hydrochloride
    65923-510Family Care Original EyeTETRAHYDROZOLINE HYDROCHLORIDE
    55315-124Freds Astringent Rdeness Reliever EyeTETRAHYDROZOLINE HYDROCHLORIDE
    11716-1187FREDS ORIGINAL EYE DROPSTETRAHYDROZOLINE HYDROCHLORIDE
    11716-0002GOODSENSE ORIGINAL EYE DROPSTETRAHYDROZOLINE HYDROCHLORIDE
    37205-139LEADER ORIGINAL FORMULATETRAHYDROZOLINE HYDROCHLORIDE
    11716-4708LEADER ORIGINAL FORMULA EYE DROPSTETRAHYDROZOLINE HYDROCHLORIDE
    66715-6832Lil Drug Store Eye DropsTetrahydrozoline Hydrochloride
    0904-6334Major Redness Reliever EyeTetrahydrozoline Hydrochloride
    55038-023OPTICAL ORIGINAL EYE DROPSTETRAHYDROZOLINE HYDROCHLORIDE
    63868-903QUALITY CHOICE ORIGINAL EYE DROPSTETRAHYDROZOLINE HYDROCHLORIDE
    11822-1536Rite Aid Original Sterile EyeTetrahydrozoline Hydrochloride
    0536-1002Rugby EyeTetrahydrozoline Hydrochloride
    11716-1609SHOPKO ORIGINAL FORMULA EYE DROPSTETRAHYDROZOLINE HYDROCHLORIDE
    65923-559Sound Body Original EyeTetrahydrozoline Hydrochloride
    58988-0148T-RAOJOtetrahydrozoline Hydrochloride
    42002-203Visine OriginalTetrahydrozoline Hydrochloride
    69968-0355Visine Red Eye ComfortTetrahydrozoline Hydrochloride
    11716-1168WALGREENS ORIGINAL EYE DROPSTETRAHYDROZOLINE HYDROCHLORIDE
    0363-7298Walgreens Sterile Original EyeTetrahydrozoline Hydrochloride
    0363-1676Walgreens Sterile Original Eye DropsTetrahydrozoline Hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.