FDA.reportPublic FDA data

Winco Maximum Redness Relief Eye Drops

Product NDC
67091-285
11-digit product format
670910285
Labeler code
67091
Product ID
67091-285_4748f87a-1ea8-2a15-e063-6394a90a28e0
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin, Naphazoline HCl
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
WinCo Foods, LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-09
Substance
GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
Active strength
500; 30 mg/100mL; mg/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Winco Maximum Redness Relief Eye Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN500 mg/100mL
NAPHAZOLINE HYDROCHLORIDE30 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
MZ1131787DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1235200Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff3651d4-42ce-4db1-a318-15f7592baf86Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-285-15Winco Maximum Redness Relief Eye Drops1 in 1 BOXSOLUTION/ DROPS15
67091-285-15Winco Maximum Redness Relief Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXMAXIMUM REDNESS RELIEF EYE (GLYCERIN, NAPHAZOLINE HCL) SOLUTION/ DROPS [WINCO FOODS, LLC]2
NAPHAZOLINE HYDROCHLORIDEACTIVE INGREDIENTMZ1131787DMAXIMUM REDNESS RELIEF EYE (GLYCERIN, NAPHAZOLINE HCL) SOLUTION/ DROPS [WINCO FOODS, LLC]2
GLYCERINACTIVE MOIETYPDC6A3C0OXMAXIMUM REDNESS RELIEF EYE (GLYCERIN, NAPHAZOLINE HCL) SOLUTION/ DROPS [WINCO FOODS, LLC]2
NAPHAZOLINEACTIVE MOIETYH231GF11BVMAXIMUM REDNESS RELIEF EYE (GLYCERIN, NAPHAZOLINE HCL) SOLUTION/ DROPS [WINCO FOODS, LLC]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7MAXIMUM REDNESS RELIEF EYE (GLYCERIN, NAPHAZOLINE HCL) SOLUTION/ DROPS [WINCO FOODS, LLC]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4MAXIMUM REDNESS RELIEF EYE (GLYCERIN, NAPHAZOLINE HCL) SOLUTION/ DROPS [WINCO FOODS, LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KMAXIMUM REDNESS RELIEF EYE (GLYCERIN, NAPHAZOLINE HCL) SOLUTION/ DROPS [WINCO FOODS, LLC]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOMAXIMUM REDNESS RELIEF EYE (GLYCERIN, NAPHAZOLINE HCL) SOLUTION/ DROPS [WINCO FOODS, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RMAXIMUM REDNESS RELIEF EYE (GLYCERIN, NAPHAZOLINE HCL) SOLUTION/ DROPS [WINCO FOODS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-285WINCO MAXIMUM REDNESS RELIEF EYE DROPS (GLYCERIN, NAPHAZOLINE HCL) SOLUTION/ DROPS [WINCO FOODS, LLC]4Current NDC, Legacy NDC, 2 package rows20240104_ff3651d4-42ce-4db1-a318-15f7592baf86.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
1235200glycerin 0.5 % / naphazoline HCl 0.03 % Ophthalmic SolutionPSNff3651d4-42ce-4db1-a318-15f7592baf865
1235200glycerin 5 MG/ML / naphazoline hydrochloride 0.3 MG/ML Ophthalmic SolutionSCDff3651d4-42ce-4db1-a318-15f7592baf865
1235200glycerin 0.5 % / naphazoline hydrochloride 0.03 % Ophthalmic SolutionSYff3651d4-42ce-4db1-a318-15f7592baf865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67091-285-15670910285151 BOTTLE, DROPPER in 1 BOX (67091-285-15) / 15 mL in 1 BOTTLE, DROPPER2015-01-090000-00-00NoNoCurrent