FDA.reportPublic FDA data

ASSURED ORIGINAL RELIEF EYE

Product NDC
33992-9376
11-digit product format
339929376
Labeler code
33992
Product ID
33992-9376_051c56f5-0fc6-4dfb-9750-2c21d6a249e4
Type
HUMAN OTC DRUG
Nonproprietary name
TETRAHYDROZOLINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
GREENBRIER INTERNATIONAL, INC.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-02-28
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
33992-9376-52020-01-31C16284748780-19d75b9cf-d859-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33992-9376-5ASSURED ORIGINAL RELIEF EYE15 mL in 1 BOTTLESOLUTION152
33992-9376-5ASSURED ORIGINAL RELIEF EYE1 in 1 CARTONSOLUTION12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DASSURED ORIGINAL RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [GREENBRIER INTERNATIONAL, INC.]2
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077ASSURED ORIGINAL RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [GREENBRIER INTERNATIONAL, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ASSURED ORIGINAL RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [GREENBRIER INTERNATIONAL, INC.]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4ASSURED ORIGINAL RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [GREENBRIER INTERNATIONAL, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KASSURED ORIGINAL RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [GREENBRIER INTERNATIONAL, INC.]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOASSURED ORIGINAL RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [GREENBRIER INTERNATIONAL, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XASSURED ORIGINAL RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [GREENBRIER INTERNATIONAL, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RASSURED ORIGINAL RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [GREENBRIER INTERNATIONAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-9376ASSURED ORIGINAL RELIEF EYE (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION [GREENBRIER INTERNATIONAL, INC.]2Legacy NDC, 2 package rows20130314_c6dc456c-aeee-4234-a036-6862c7249d31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSNc6dc456c-aeee-4234-a036-6862c7249d312
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDc6dc456c-aeee-4234-a036-6862c7249d312
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSYc6dc456c-aeee-4234-a036-6862c7249d312
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSYc6dc456c-aeee-4234-a036-6862c7249d312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33992-9376-53399293760515 mL in 1 BOTTLE15 mlHistorical