FDA.reportPublic FDA data

Clear Eyes Cooling Redness Relief

Product NDC
67172-393
11-digit product format
671720393
Labeler code
67172
Product ID
67172-393_8ac824d6-8b33-480e-afae-e11a735fd7d4
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin and Naphazoline Hydrochloride
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Prestige Brands Holdings, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-02-15
Substance
NAPHAZOLINE HYDROCHLORIDE; GLYCERIN
Active strength
.3; 5 mg/mL; mg/mL
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
Clear Eyes Cooling Redness Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPHAZOLINE HYDROCHLORIDE.3 mg/mL
GLYCERIN5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MZ1131787DInternal UNII lookup
PDC6A3C0OXInternal 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
38d14e99-e4c8-431b-b106-578eeb38bf3cAvailable 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
67172-393-01Clear Eyes Cooling Redness Relief1 in 1 BOXLIQUID16
67172-393-01Clear Eyes Cooling Redness Relief15 mL in 1 BOTTLE, DROPPERLIQUID156

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXCLEAR EYES COOLING REDNESS RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]1
NAPHAZOLINE HYDROCHLORIDEACTIVE INGREDIENTMZ1131787DCLEAR EYES COOLING REDNESS RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]1
GLYCERINACTIVE MOIETYPDC6A3C0OXCLEAR EYES COOLING REDNESS RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]1
NAPHAZOLINEACTIVE MOIETYH231GF11BVCLEAR EYES COOLING REDNESS RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7CLEAR EYES COOLING REDNESS RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]1
BETADEXINACTIVE INGREDIENTJV039JZZ3ACLEAR EYES COOLING REDNESS RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4CLEAR EYES COOLING REDNESS RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCLEAR EYES COOLING REDNESS RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ACLEAR EYES COOLING REDNESS RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]1
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOCLEAR EYES COOLING REDNESS RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCLEAR EYES COOLING REDNESS RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67172-393CLEAR EYES COOLING REDNESS RELIEF (GLYCERIN AND NAPHAZOLINE HYDROCHLORIDE) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]6Current NDC, Legacy NDC, 2 package rows20241101_38d14e99-e4c8-431b-b106-578eeb38bf3c.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 20 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
application number: M018
Polyvinyl AlcoholPOLYVINYL ALCOHOLA-S Medication Solutionsc77589fd-f68d-48b7-bd12-51f6b4cc94022024-03-20WarningsExact identifier
application number: M018
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
application number: M018
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
application number: M018
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
application number: M018
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort, CVPTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 SOLUTION/ DROPSLil' Drug Store Products, Inc.0f50bcc8-3658-8c2c-e063-6294a90a8e132024-01-19WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
application number: M018
Exchange Select Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLArmy and Air Force Exchange Service318bc025-c936-a066-e063-6294a90a47122024-01-01WarningsExact identifier
application number: M018
Kroger Eye Drops OriginalTETRAHYDROZOLINE HCLThe Kroger Co.318c17a1-fe08-508b-e063-6394a90a2e082024-01-01WarningsExact identifier
application number: M018
HEB Original Eye DropsTETRAHYDROZOLINE HCLHEB Grocery Company, LP318cb457-bb2d-a1ee-e063-6294a90a80192024-01-01WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops Multi-Symptom ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEDiscount Drug Mart, Inc.318dc92a-0707-d6a4-e063-6294a90ab78a2024-01-01WarningsExact identifier
application number: M018
Kroger Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEThe Kroger Co.318dea21-2656-36a3-e063-6294a90ac9c42024-01-01WarningsExact identifier
application number: M018
Harris Teeter Eye Drops OriginalTETRAHYDROZOLINE HCLHarris Teeter, LLC.P31a1b962-27ad-97b1-e063-6294a90a77f12024-01-01WarningsExact identifier
application number: M018
CVP Sterile Eye DropsTETRAHYDROZOLINE HCLSalado Sales, Inc.31a216f8-28e9-ec8f-e063-6394a90aec492024-01-01WarningsExact identifier
application number: M018
Equaline Sterile Eye DropsTETRAHYDROZOLINE HCLUnited Natural Foods, Inc.31a25efb-a627-1a13-e063-6394a90a2ca32024-01-01WarningsExact identifier
application number: M018
Best Choice Eye Drops OriginalTETRAHYDROZOLINE HCLValu Merchandisers Company31a2a42a-bcfe-4f22-e063-6294a90ac60e2024-01-01WarningsExact identifier
application number: M018
Discount Drug Mart Eye Drops OriginalTETRAHYDROZOLINE HCLDiscount Drug Mart, Inc.31a2efb2-3924-6a12-e063-6394a90ab0e22024-01-01WarningsExact identifier
application number: M018
Equaline Redness Relief Lubricant Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc31a30b00-9f4b-717a-e063-6394a90a8a872024-01-01WarningsExact identifier
application number: M018
Harris Teeter Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEHarris Teeter, LLC.31a3d575-10f1-5feb-e063-6294a90ac4782024-01-01WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235200glycerin 0.5 % / naphazoline HCl 0.03 % Ophthalmic SolutionPSN38d14e99-e4c8-431b-b106-578eeb38bf3c6
1235200glycerin 5 MG/ML / naphazoline hydrochloride 0.3 MG/ML Ophthalmic SolutionSCD38d14e99-e4c8-431b-b106-578eeb38bf3c6
1235200glycerin 0.5 % / naphazoline hydrochloride 0.03 % Ophthalmic SolutionSY38d14e99-e4c8-431b-b106-578eeb38bf3c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67172-393-01671720393011 BOTTLE, DROPPER in 1 BOX (67172-393-01) / 15 mL in 1 BOTTLE, DROPPER2011-02-150000-00-00NoNoCurrent