SHOPKO ADVANCED FORMULA EYE DROPS

Product NDC
11716-0458
11-digit product format
117160458
Labeler code
11716
Product ID
11716-0458_cf47d75f-6acf-4e22-acd5-88c24d82754d
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTRAN 70
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
DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
0 mL/mL; mL/mL; mL/mL; mL/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
11716-0458-52020-01-31C16284748780-19d75b9d0-1ea3-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11716-0458-5SHOPKO ADVANCED FORMULA EYE DROPS15 mL in 1 BOTTLESOLUTION151
11716-0458-5SHOPKO ADVANCED FORMULA EYE DROPS1 in 1 CARTONSOLUTION11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTRAN 70ACTIVE INGREDIENT7SA290YK68SHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQSHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1
POVIDONEACTIVE INGREDIENTFZ989GH94ESHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DSHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1
DEXTRAN 70ACTIVE MOIETY7SA290YK68SHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQSHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1
POVIDONEACTIVE MOIETYFZ989GH94ESHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077SHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7SHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4SHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOSHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RSHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11716-0458SHOPKO ADVANCED FORMULA EYE DROPS (DEXTRAN 70) SOLUTION [HANLIM PHARM. CO., LTD.]1Legacy NDC, 2 package rows20100817_2872dc33-5e6b-4291-9e5a-c86413ed0357.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN2872dc33-5e6b-4291-9e5a-c86413ed03571
996202dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD2872dc33-5e6b-4291-9e5a-c86413ed03571
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionSY2872dc33-5e6b-4291-9e5a-c86413ed03571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
11716-0458-51171604580515 mL in 1 BOTTLE15 mlHistorical