FDA.reportPublic FDA data

DG HEALTH ORIGINAL

Product NDC
11716-0053
11-digit product format
117160053
Labeler code
11716
Product ID
11716-0053_67fddf3f-80e0-4fda-84fc-c0154c0c2d42
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
2010-08-12
Marketing end
0000-00-00
Substance
TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
1 mg/mL
NDC exclude flag
E
Listing certified through
2018-12-31
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
11716-0053-92020-01-31C16284748780-19d75b9d0-7c63-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11716-0053-9DG HEALTH ORIGINAL15 mL in 1 BOTTLESOLUTION152
11716-0053-9DG HEALTH ORIGINAL1 in 1 CARTONSOLUTION12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DDG HEALTH ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077DG HEALTH ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DG HEALTH ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4DG HEALTH ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDG HEALTH ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QODG HEALTH ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDG HEALTH ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2
WATERINACTIVE INGREDIENT059QF0KO0RDG HEALTH ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11716-0053DG HEALTH ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [HANLIM PHARM. CO., LTD.]2Legacy NDC, 2 package rows20100813_ca210129-4577-45a0-b7e4-93130d9f962e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSNca210129-4577-45a0-b7e4-93130d9f962e2
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDca210129-4577-45a0-b7e4-93130d9f962e2
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSYca210129-4577-45a0-b7e4-93130d9f962e2
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSYca210129-4577-45a0-b7e4-93130d9f962e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
11716-0053-91171600530915 mL in 1 BOTTLE15 mlHistorical