FDA.reportPublic FDA data

Clear Eyes Maximum Itchy Eye Relief

Product NDC
67172-999
11-digit product format
671720999
Labeler code
67172
Product ID
67172-999_5b2756d6-2d54-22a4-e063-6394a90aed7d
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin and Naphazoline Hydrochloride and Zinc Sulfate
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Prestige Brands Holdings, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-03-15
Substance
GLYCERIN; NAPHAZOLINE HYDROCHLORIDE; ZINC SULFATE
Active strength
2.5; .12; 2.5 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67172-99967172-999-06DDiscontinued by firm2026-10-23

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
Clear Eyes Maximum Itchy Eye Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN2.5 mg/mL
NAPHAZOLINE HYDROCHLORIDE.12 mg/mL
ZINC SULFATE2.5 mg/mL

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
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67172-999-01Clear Eyes Maximum Itchy Eye Relief1 in 1 BOXLIQUID112
67172-999-01Clear Eyes Maximum Itchy Eye Relief15 mL in 1 BOTTLE, DROPPERLIQUID1512
67172-999-06Clear Eyes Maximum Itchy Eye Relief1 in 1 CARTONLIQUID112
67172-999-06Clear Eyes Maximum Itchy Eye Relief6 mL in 1 BOTTLE, DROPPERLIQUID612

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXCLEAR EYES MAXIMUM ITCHY EYE RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]2
NAPHAZOLINE HYDROCHLORIDEACTIVE INGREDIENTMZ1131787DCLEAR EYES MAXIMUM ITCHY EYE RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]2
ZINC SULFATEACTIVE INGREDIENT89DS0H96TBCLEAR EYES MAXIMUM ITCHY EYE RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]2
GLYCERINACTIVE MOIETYPDC6A3C0OXCLEAR EYES MAXIMUM ITCHY EYE RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]2
NAPHAZOLINEACTIVE MOIETYH231GF11BVCLEAR EYES MAXIMUM ITCHY EYE RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]2
ZINC CATIONACTIVE MOIETY13S1S8SF37CLEAR EYES MAXIMUM ITCHY EYE RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CLEAR EYES MAXIMUM ITCHY EYE RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4CLEAR EYES MAXIMUM ITCHY EYE RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCLEAR EYES MAXIMUM ITCHY EYE RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCLEAR EYES MAXIMUM ITCHY EYE RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCLEAR EYES MAXIMUM ITCHY EYE RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCLEAR EYES MAXIMUM ITCHY EYE RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67172-999CLEAR EYES MAXIMUM ITCHY EYE RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE AND ZINC SULFATE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]10Current NDC, Legacy NDC, 4 package rows20240820_326a1462-78d1-42d6-8257-7e4f00d1f215.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 · 486 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
application number: M018
Capasil Pain RelievingMENTHOL, METHYL SALICYLATEPureTek Corporationb1a8e78c-57f0-1f3e-e053-2995a90acbd52024-10-01WarningsExact identifier
application number: M018
Mencylate Pain RelievingMENTHOL, METHYL SALICYLATEPureTek Corporationf824de86-9492-2e6b-e053-6294a90a6f2a2024-10-01WarningsExact identifier
application number: M018
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
application number: M018
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporatedcc3d5bc8-9d3c-4c65-9e43-707a2db4081a2024-09-25WarningsExact identifier
application number: M018
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporated93fafa27-5031-4d95-b4b8-5574b7204ae22024-09-25WarningsExact identifier
application number: M018
Muro 128SODIUM CHLORIDEBausch & Lomb Incorporated454f337e-d897-46de-ab05-1c543a33061c2024-09-25WarningsExact identifier
application number: M018
PURPOSEOCTINOXATE, OCTISALATE AND OXYBENZONEBausch & Lomb Incorporateda1e14135-b8da-4cee-8c5b-1893572f4de42024-09-25WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046644glycerin 0.25 % / naphazoline HCl 0.012 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN326a1462-78d1-42d6-8257-7e4f00d1f21512
1046644glycerin 2.5 MG/ML / naphazoline hydrochloride 0.12 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD326a1462-78d1-42d6-8257-7e4f00d1f21512
1046644glycerin 0.25 % / naphazoline HCl 0.012 % / zinc sulfate 0.25 % Ophthalmic SolutionSY326a1462-78d1-42d6-8257-7e4f00d1f21512
1046644Glycerin 2.5 MG/ML / Naphazoline Hydrochloride 0.12 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY326a1462-78d1-42d6-8257-7e4f00d1f21512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67172-999-01671720999011 BOTTLE, DROPPER in 1 BOX (67172-999-01) / 15 mL in 1 BOTTLE, DROPPER2011-03-150000-00-00NoNoCurrent
67172-999-06671720999061 BOTTLE, DROPPER in 1 CARTON (67172-999-06) > 6 mL in 1 BOTTLE, DROPPER2018-09-040000-00-00NoNoCurrent