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

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 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 18 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OASIS Tears Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.d9d71b1d-82a6-42e7-9ef2-2d041daef9362024-12-23WarningsExact identifier
application number: M018
Ancient Secrets Breathe AgainSODIUM CHLORIDELOTUS BRANDS, INC.c6d2bab0-d363-4c09-a71b-ae15db915b372024-12-18WarningsExact identifier
application number: M018
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMMEDTECH PRODUCTS INC77f504c1-b8e0-4371-ac3e-9d453d84714b2024-12-13WarningsExact identifier
application number: M018
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDMEDTECH PRODUCTS INCf1845041-9d8d-42a0-a2cb-68def7a5aac72024-12-13WarningsExact identifier
application number: M018
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
application number: M018
Systane NighttimeMINERAL OIL AND WHITE PETROLATUMAlcon Laboratories, Inc.4689c59c-5721-3f91-6c85-e41501998fd02024-12-05WarningsExact identifier
application number: M018
GenTeal Tears NIGHT-TIMEMINERAL OIL, WHITE PETROLATUMAlcon Laboratories, Inc.9d5998a7-4f59-4293-87da-8419650a524d2024-12-05WarningsExact identifier
application number: M018
Visine Red Eye Total Comfort and Tears Dry Eye ReliefTETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATEKenvue Brands LLC0bc0d6e7-9195-db6b-e063-6294a90aef042024-11-14WarningsExact identifier
application number: M018
Visine Red Eye ComfortTETRAHYDROZOLINE HYDROCHLORIDEKenvue Brands LLCd7abd7cb-e094-481f-bea5-a5983e2c9ef42024-11-13WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Kenvue Brands LLCa9a90de6-3172-4d34-984b-f4442f880e3d2024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLC2de7a41d-661d-495f-89b4-5690664a3a3d2024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye Relief Eye DropsPOLYETHYLENE GLYCOL 400Kenvue Brands LLCd9d3f000-3ce4-4ba2-a7fb-491b44eb3fa12024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLCa4c57620-778f-4434-9105-ead2f85c58842024-11-13WarningsExact identifier
application number: M018
Visine A.C. Itchy Eye ReliefTETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC257b9666-0163-499b-9673-bf6f4d6899b12024-11-13WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLAcme United Corporationf19fbe28-b928-7c6e-e053-2995a90a43cb2024-11-09WarningsExact identifier
application number: M018
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
application number: M018
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
application number: M018
Clear Eyes Cooling Redness ReliefGLYCERIN AND NAPHAZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.38d14e99-e4c8-431b-b106-578eeb38bf3c2024-10-25WarningsExact identifier
application number: M018
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
application number: M018
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact 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