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 14 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb479d2ae-4b59-916a-e053-2995a90af8ec2025-11-11WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDERising Pharma Holdings, Inc.42870188-b1d7-4934-a6c0-310530497dac2025-11-07WarningsExact identifier
application number: M018
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
application number: M018
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
application number: M018
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
application number: M018
Up and Up Dry Eye Relief Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMTarget Corporation3b1834e6-75cf-5380-e063-6294a90ad1d52025-10-25WarningsExact identifier
application number: M018
Up and Up Dry Eye Relief Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHanlim420274c6-7bf0-0920-e063-6294a90a30be2025-10-25WarningsExact identifier
application number: M018
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
application number: M018
TheraTears LubricantCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC797b0394-2f0f-4733-8d20-ec5bdf3e085d2025-10-23WarningsExact identifier
application number: M018
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
application number: M018
TheraTears LubricantCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC661d8764-8ae6-4229-9485-867553ee8e162025-10-23WarningsExact identifier
application number: M018
Refresh Relieva Preservative FreeCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.3481f9b3-5a90-40d3-80f8-81f51cc864be2025-10-22WarningsExact identifier
application number: M018
Sodium Chloride Normal SaltSODIUM CHLORIDEMethod Pharmaceuticalsce84727a-3677-4bf0-e053-2995a90a3ec82025-10-21WarningsExact identifier
application number: M018
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
application number: M018
Walgreens Ultra LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4533-2061-e063-6394a90a6e732025-10-17WarningsExact identifier
application number: M018
WalgreensSODIUM CHLORIDEWalgreen Company21dfc2cf-65ae-c3fb-e063-6294a90a0a942025-10-17Exact identifier
application number: M018
Xpect Industrial Eye ReliefGLYCERIN, NAPHAZOLINE HCLCintas Corporationa0167d06-7adb-36f4-e053-2a95a90af9ef2025-09-30WarningsExact identifier
application number: M018
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
application number: M018
REFRESH OPTIVE DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
application number: M018
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact 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