FDA.reportPublic FDA data

PREMIER VALUE ORIGINAL

Product NDC
11716-0101
11-digit product format
117160101
Labeler code
11716
Product ID
11716-0101_2383b6cc-a845-4599-b785-d35391f88cbf
Type
HUMAN OTC DRUG
Nonproprietary name
TETRAHYDROZOLINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
HANLIM PHARM. CO., LTD.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-05-19
Marketing end
0000-00-00
Substance
TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11716-0101-12020-01-31C16284748780-19d75b9d0-a8a6-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11716-0101-1PREMIER VALUE ORIGINAL1 in 1 CARTONSOLUTION12
11716-0101-1PREMIER VALUE ORIGINAL15 mL in 1 BOTTLESOLUTION152

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DPREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077PREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7PREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4PREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOPREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
WATERINACTIVE INGREDIENT059QF0KO0RPREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11716-0101PREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2Legacy NDC, 2 package rows20140519_b75edf79-0bde-46f4-a1d0-ba1b44eb56c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSNb75edf79-0bde-46f4-a1d0-ba1b44eb56c42
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDb75edf79-0bde-46f4-a1d0-ba1b44eb56c42
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSYb75edf79-0bde-46f4-a1d0-ba1b44eb56c42
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSYb75edf79-0bde-46f4-a1d0-ba1b44eb56c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11716-0101-1117160101011 in 1 CARTONHistorical