FDA.reportPublic FDA data

Winco Irritation Relief Eye

Product NDC
67091-283
11-digit product format
670910283
Labeler code
67091
Product ID
67091-283_4748fa49-da06-de6d-e063-6294a90ac278
Type
HUMAN OTC DRUG
Nonproprietary name
Tetrahydrozoline HCl, Zinc sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
WinCo Foods, LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-09
Substance
TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE
Active strength
50; 250 mg/100mL; mg/100mL
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
Winco Irritation Relief Eye
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRAHYDROZOLINE HYDROCHLORIDE50 mg/100mL
ZINC SULFATE250 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0YZT43HS7DInternal UNII lookup
89DS0H96TBInternal 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
60565184-5745-43a5-92b2-ab45b27e8bc6Available 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
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
67091-283-15Winco Irritation Relief Eye15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155
67091-283-15Winco Irritation Relief Eye1 in 1 BOXSOLUTION/ DROPS15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DIRRITATION RELIEF EYE (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION/ DROPS [WINCO FOODS, LLC]2
ZINC SULFATEACTIVE INGREDIENT89DS0H96TBIRRITATION RELIEF EYE (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION/ DROPS [WINCO FOODS, LLC]2
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077IRRITATION RELIEF EYE (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION/ DROPS [WINCO FOODS, LLC]2
ZINC CATIONACTIVE MOIETY13S1S8SF37IRRITATION RELIEF EYE (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION/ DROPS [WINCO FOODS, LLC]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7IRRITATION RELIEF EYE (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION/ DROPS [WINCO FOODS, LLC]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4IRRITATION RELIEF EYE (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION/ DROPS [WINCO FOODS, LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KIRRITATION RELIEF EYE (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION/ DROPS [WINCO FOODS, LLC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XIRRITATION RELIEF EYE (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION/ DROPS [WINCO FOODS, LLC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRIRRITATION RELIEF EYE (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION/ DROPS [WINCO FOODS, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RIRRITATION RELIEF EYE (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION/ DROPS [WINCO FOODS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-283WINCO IRRITATION RELIEF EYE (TETRAHYDROZOLINE HCL, ZINC SULFATE) SOLUTION/ DROPS [WINCO FOODS, LLC]4Current NDC, Legacy NDC, 2 package rows20240104_60565184-5745-43a5-92b2-ab45b27e8bc6.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 25 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Lubricating DropsPOLYVINYL ALCOHOLA-S Medication Solutionsf2e26f85-4081-425b-9c81-ac2a079a57432023-11-10WarningsExact identifier
application number: M018
SalineNASALGERI-CARE PHARMACEUTICAL CORPd293cc13-4043-0d58-e053-2995a90a3fbc2023-10-24WarningsExact identifier
application number: M018
Eyeganics Organic TearsGLYCERINEyeganics LLC42470af7-a3ae-4e14-88e0-04cd92db4b372023-10-13WarningsExact identifier
application number: M018
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
application number: M018
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
application number: M018
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
application number: M018
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
application number: M018
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
application number: M018
REFRESH TEARSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.329d1fe0-4432-4565-b7b1-65666bd865262022-06-30WarningsExact identifier
application number: M018
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
application number: M018
REFRESH P.M.MINERAL OIL, PETROLATUMAllergan, Inc.24365d64-cd94-41cc-a7e1-033102d981142022-06-30WarningsExact identifier
application number: M018
REFRESH PLUSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.0f6a4b4b-cde6-4518-84b5-ce997f1154a72022-06-28WarningsExact identifier
application number: M018
CIRCLE K sterile eye dropsTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0e106c-16f6-ff4e-e063-6294a90a7dbb2018-07-30WarningsExact identifier
application number: M018
Lil Drug Store Sterile Eye Drops Redness RelieverTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0ea35c-ac52-1043-e063-6394a90a061c2018-04-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN60565184-5745-43a5-92b2-ab45b27e8bc65
1043249tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD60565184-5745-43a5-92b2-ab45b27e8bc65
1043249tetrahydrozoline HCl 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY60565184-5745-43a5-92b2-ab45b27e8bc65
1043249Tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY60565184-5745-43a5-92b2-ab45b27e8bc65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67091-283-15670910283151 BOTTLE, DROPPER in 1 BOX (67091-283-15) / 15 mL in 1 BOTTLE, DROPPER2015-01-090000-00-00NoNoCurrent