FDA.reportPublic FDA data

SHOPKO RELIEF

Product NDC
11716-0460
11-digit product format
117160460
Labeler code
11716
Product ID
11716-0460_505ed84a-9943-43b3-9240-f47cb0a6ea3c
Type
HUMAN OTC DRUG
Nonproprietary name
TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
HANLIM PHARM. CO., LTD.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-10-08
Marketing end
0000-00-00
Substance
TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE
Active strength
1 mg/mL; 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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11716-0460-12020-01-31C16284748780-19d75b9cf-f89c-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11716-0460-1SHOPKO RELIEF15 mL in 1 BOTTLESOLUTION153
11716-0460-1SHOPKO RELIEF1 in 1 CARTONSOLUTION13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DSHOPKO RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.]3
ZINC SULFATEACTIVE INGREDIENT89DS0H96TBSHOPKO RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.]3
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077SHOPKO RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.]3
ZINCACTIVE MOIETYJ41CSQ7QDSSHOPKO RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7SHOPKO RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.]3
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4SHOPKO RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSHOPKO RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSHOPKO RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSHOPKO RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.]3
WATERINACTIVE INGREDIENT059QF0KO0RSHOPKO RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11716-0460SHOPKO RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE) SOLUTION [HANLIM PHARM. CO., LTD.]3Legacy NDC, 2 package rows20101013_4c732e9c-4d64-4deb-83d9-ffeb5da72c26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN4c732e9c-4d64-4deb-83d9-ffeb5da72c263
1043249tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD4c732e9c-4d64-4deb-83d9-ffeb5da72c263
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY4c732e9c-4d64-4deb-83d9-ffeb5da72c263
1043249Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY4c732e9c-4d64-4deb-83d9-ffeb5da72c263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
11716-0460-11171604600115 mL in 1 BOTTLE15 mlHistorical