FDA.reportPublic FDA data

Medics Choice Eye Drops Seasonal Relief

Product NDC
55651-024
11-digit product format
556510024
Labeler code
55651
Product ID
55651-024_4748cbbd-a95a-77cf-e063-6294a90a92b5
Type
HUMAN OTC DRUG
Nonproprietary name
tetrahydrozoline hydrochloride, zinc sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
KC Pharmaceuticals, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2003-10-23
Substance
TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE
Active strength
.5; 2.5 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Seasonal Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC SULFATE2.5 mg/mL
TETRAHYDROZOLINE HYDROCHLORIDE.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89DS0H96TBInternal UNII lookup
0YZT43HS7DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043249Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
92bd8cb4-90ad-4a47-afa4-30d1fa658d62Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55651-024-01Medics Choice Eye Drops Seasonal Relief1 in 1 CARTONSOLUTION/ DROPS16
55651-024-01Medics Choice Eye Drops Seasonal Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS156

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DEYE DROPS AC (TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
ZINC SULFATEACTIVE INGREDIENT89DS0H96TBEYE DROPS AC (TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077EYE DROPS AC (TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
ZINCACTIVE MOIETYJ41CSQ7QDSEYE DROPS AC (TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7EYE DROPS AC (TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4EYE DROPS AC (TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEYE DROPS AC (TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEYE DROPS AC (TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULREYE DROPS AC (TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0REYE DROPS AC (TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55651-024MEDICS CHOICE EYE DROPS SEASONAL RELIEF (TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20240110_92bd8cb4-90ad-4a47-afa4-30d1fa658d62.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 1 of 26 · 509 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraTearsCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC17a01236-130f-495b-9f8d-92b6a23b2dc52026-09-09WarningsExact identifier
application number: M018
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
application number: M018
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
application number: M018
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
application number: M018
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
application number: M018
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
application number: M018
REFRESH LIQUIGELCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.4b8b2f6a-4b89-446c-9e5b-9b83c453a01d2026-08-28WarningsExact identifier
application number: M018
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
application number: M018
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
application number: M018
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
application number: M018
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5967ef02-6770-bfd7-e063-6294a90a79042026-08-19WarningsExact identifier
application number: M018
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
application number: M018
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
application number: M018
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
application number: M018
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5905b300-6f1f-a61f-e063-6394a90a11232026-08-14WarningsExact identifier
application number: M018
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
application number: M018
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
application number: M018
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
application number: M018
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN92bd8cb4-90ad-4a47-afa4-30d1fa658d626
1043249tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD92bd8cb4-90ad-4a47-afa4-30d1fa658d626
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY92bd8cb4-90ad-4a47-afa4-30d1fa658d626
1043249Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY92bd8cb4-90ad-4a47-afa4-30d1fa658d626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55651-024-01556510024011 BOTTLE, DROPPER in 1 CARTON (55651-024-01) / 15 mL in 1 BOTTLE, DROPPER2003-10-230000-00-00NoNoCurrent