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 23 of 25 · 486 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUMThe Kroger Co.046f4ebc-d8f9-4755-b6ba-790fe86f31282023-12-20WarningsExact identifier
application number: M018
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
application number: M018
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
application number: M018
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
application number: M018
Topcare Health Ultra Itch Relief Astringent Eye DropsTETRAHYDROZOLINE HCL, ZINC SULFATETopco Associates LLC9c617e34-fc64-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
application number: M018
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
application number: M018
Topcare Health Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTopco Assoc LLC9c6284f9-00bb-37b5-e053-2a95a90ae2ee2023-12-20WarningsExact identifier
application number: M018
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
application number: M018
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
application number: M018
Topcare Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDETopco Assoc LLC9c6193a6-d824-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
application number: M018
HEB Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHEB5d522e4d-d647-486f-a947-25c14b1417fa2023-12-20WarningsExact identifier
application number: M018
HEB A.C. Eye DropsTETRAHYDROZOLINE HCL, ZINC SULFATEHEB Grocery Company., LPf680a8c1-dc91-7a52-e053-2a95a90a571e2023-12-20WarningsExact identifier
application number: M018
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
application number: M018
Equaline Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEUnited Natural Foods, Inc.f5f894f0-1ab0-4cad-e053-2995a90a7cba2023-12-20WarningsExact identifier
application number: M018
Cleareyes Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINLil' Drug Store Products, Inc.39e4ab2b-ae12-4339-b219-109cf0f7f06a2023-12-15WarningsExact identifier
application number: M018
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
application number: M018
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.db3a6c68-320b-46b0-83fa-6c29297a84a62023-12-15WarningsExact identifier
application number: M018
SystanePOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLAlcon Research Ltd14916d2c-a63d-491e-bd91-a61f300af38a2023-12-15WarningsExact identifier
application number: M018
SystaneHYPROMELLOSEAlcon Laboratories, Inc.5f74b161-ae41-d0e2-6ed9-8deca55d2c0f2023-12-15WarningsExact identifier
application number: M018
Systane Day and Night Value PackPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3%Alcon Laboratories, Inc.df13ca6f-7ce1-455a-ae13-9bbc5e9d2e072023-12-15WarningsExact 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