FDA.reportPublic FDA data

Medics Choice Eye Drops Advanced

Product NDC
55651-025
11-digit product format
556510025
Labeler code
55651
Product ID
55651-025_4748d5b2-f2f1-e88b-e063-6394a90af39a
Type
HUMAN OTC DRUG
Nonproprietary name
tetrahydrozoline hydrochloride, polyethylene glycol 400, dextran 70, povidone
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
KC Pharmaceuticals, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2003-12-09
Substance
DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
1; 10; 10; .5 mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes
Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Medics Choice Eye Drops Advanced
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTRAN 701 mg/mL
POLYETHYLENE GLYCOL 40010 mg/mL
POVIDONE10 mg/mL
TETRAHYDROZOLINE HYDROCHLORIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7SA290YK68, B697894SGQ, FZ989GH94E, 0YZT43HS7D
Rxcui996202

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55651-025-01Medics Choice Eye Drops Advanced1 in 1 CARTONSOLUTION/ DROPS15
55651-025-01Medics Choice Eye Drops Advanced15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTRAN 70ACTIVE INGREDIENT7SA290YK68EYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQEYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
POVIDONEACTIVE INGREDIENTFZ989GH94EEYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DEYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
DEXTRAN 70ACTIVE MOIETY7SA290YK68EYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQEYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
POVIDONEACTIVE MOIETYFZ989GH94EEYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077EYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7EYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4EYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOEYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0REYE DROPS ADVANCED RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55651-025MEDICS CHOICE EYE DROPS ADVANCED (TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20240110_ab906fd8-265c-4359-a920-d626366e245c.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 SolutionPSNab906fd8-265c-4359-a920-d626366e245c5
996202dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCDab906fd8-265c-4359-a920-d626366e245c5
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionSYab906fd8-265c-4359-a920-d626366e245c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55651-025-01556510025011 BOTTLE, DROPPER in 1 CARTON (55651-025-01) / 15 mL in 1 BOTTLE, DROPPER2003-12-090000-00-00NoNoCurrent