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

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 Identifiers#

Field, Values table
FieldValues
Unii0YZT43HS7D, 89DS0H96TB
Rxcui1043249

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

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