Family Care Advanced Formula Eye

Product NDC
65923-511
11-digit product format
659230511
Labeler code
65923
Product ID
65923-511_9ee3113e-3f1c-50dc-e053-2a95a90a2eb6
Type
HUMAN OTC DRUG
Nonproprietary name
Tetrahydrozoline hydrochloride, dextran 70, polyethylene glycol 400, povidone
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
United Exchange Corp
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-11-25
Marketing end
0000-00-00
Substance
TETRAHYDROZOLINE HYDROCHLORIDE; DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE
Active strength
1 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65923-511DDiscontinued by firm2026-10-12
excluded packagepackage65923-51165923-511-15DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTRAN 70ACTIVE INGREDIENT7SA290YK68FAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]4
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQFAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]4
POVIDONEACTIVE INGREDIENTFZ989GH94EFAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]4
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DFAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]4
DEXTRAN 70ACTIVE MOIETY7SA290YK68FAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]4
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQFAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]4
POVIDONEACTIVE MOIETYFZ989GH94EFAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]4
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077FAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7FAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]4
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4FAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]4
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOFAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XFAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]4
WATERINACTIVE INGREDIENT059QF0KO0RFAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-511FAMILY CARE ADVANCED FORMULA EYE (TETRAHYDROZOLINE HYDROCHLORIDE, DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE) SOLUTION/ DROPS [UNITED EXCHANGE CORP]7Legacy NDC20241215_716d2f37-ae19-42b1-9d85-d07777dedaed.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65923-511-15659230511151 BOTTLE in 1 CARTON (65923-511-15) > 15 mL in 1 BOTTLE1 bottle2014-11-250000-00-00NoNoCurrent