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
POVIDONE; POLYETHYLENE GLYCOL 400; TETRAHYDROZOLINE HYDROCHLORIDE; DEXTRAN 70
Active strength
10; 10; .5; 1 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

Reported adverse events (FAERS/openFDA)#

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

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
POVIDONE10 mg/mL
POLYETHYLENE GLYCOL 40010 mg/mL
TETRAHYDROZOLINE HYDROCHLORIDE.5 mg/mL
DEXTRAN 701 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FZ989GH94EInternal UNII lookup
B697894SGQInternal UNII lookup
0YZT43HS7DInternal UNII lookup
7SA290YK68Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996202Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab906fd8-265c-4359-a920-d626366e245cAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 16 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
application number: M018
LubriFresh PMLIGHT MINERAL OIL, WHITE PETROLATUMMajor Pharmaceuticals3ab32e69-b8da-f187-e063-6294a90afa9a2025-07-24WarningsExact identifier
application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye DropsPOLYVINYL ALCOHOLA-S Medication Solutions2653e4fc-4f08-426d-a0a4-31d647c1de562025-07-18WarningsExact identifier
application number: M018
Focus Tears PFCARBOXYMETHYLCELLULOSE SODIUMCovalent Medical772c7070-82ff-4371-b071-940ff91372c62025-07-17WarningsExact identifier
application number: M018
SilkTearsGLYCERIN OPHTHALMIC SOLUTIONSilkTears3866e2c1-051b-0b01-e063-6394a90af5cf2025-07-16WarningsExact identifier
application number: M018
Eyeleve MGDMINERAL OILBruder Healthcare145b66e2-00e1-410e-8539-e12ffc4f6f822025-07-15WarningsExact identifier
application number: M018
Quality Choice Eye Drops Redness ReliefTETRAHYDROZOLINE HCLChain Drug Marketing Assoc., Inc.38d2bc34-c6f0-a09c-e063-6394a90a69e12025-06-26WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Morning Star OTCdcd4164c-aa1e-4f07-ab2c-b439275629db2025-06-16WarningsExact identifier
application number: M018
Code Red Eye Drops MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
application number: M018
Biotrue Hydration BoostGLYCERINBausch & Lomb Incorporatede2621477-e6ee-4275-ba0a-939dca2550c42025-05-19WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
application number: M018
Splash Redness RelieverHYPROMELLOSE, NAPHAZOLINE HYDROCHLORIDELABORATORIOS SOPHIA, S.A. DE C.V.fa4140e6-dc80-da99-e053-6294a90a194f2025-05-09WarningsExact identifier
application number: M018
Vista Gonio Eye LubricantHYPROMELLOSE OPHTHALMIC SOLUTIONRed Wedding LLC00da365d-2988-9c9e-e063-6294a90a89312025-03-25WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDE TABLETBelleview Bioscience LLC31195e8f-d4de-9e37-e063-6294a90a41562025-03-24WarningsExact identifier
application number: M018
Leader Nighttime Relief Lubricant EyeLIGHT MINERAL OIL, WHITE PETROLATUMLEADER/Cardinal Health 110, Inc.308772fc-d6f6-da9f-e063-6394a90a41db2025-03-12WarningsExact identifier
application number: M018
Clear Eyes Maximum Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINPrestige Brands Holdings, Inc.c3b0e344-68dd-4c35-bf46-744e612a5b152025-02-28WarningsExact identifier
application number: M018
Blink Nourish Dry EyeGLYCERINBausch & Lomb Incorporatedcf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a42025-02-25WarningsExact identifier
application number: M018
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
application number: M018
Hydropure Lubricating Eye DropsGLYCERINOTE North America17f5b6e5-dc14-45c7-e063-6294a90af43d2025-02-14WarningsExact identifier
application number: M018
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
application number: M018

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