FDA.reportPublic FDA data

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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11716-0458IInactivated by FDA2026-07-31
excluded packagepackage11716-045811716-0458-5IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WinCo Foods Saline Nasal ReliefSODIUM CHLORIDEWinCo Foods, LLC1280fee4-e763-49ba-8722-8cdb8157f1a42018-08-02WarningsExact identifier
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

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