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

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

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