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 16 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
application number: M018
LubriFresh PMLIGHT MINERAL OIL, WHITE PETROLATUMMajor Pharmaceuticals3ab32e69-b8da-f187-e063-6294a90afa9a2025-07-24WarningsExact identifier
application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye DropsPOLYVINYL ALCOHOLA-S Medication Solutions2653e4fc-4f08-426d-a0a4-31d647c1de562025-07-18WarningsExact identifier
application number: M018
Focus Tears PFCARBOXYMETHYLCELLULOSE SODIUMCovalent Medical772c7070-82ff-4371-b071-940ff91372c62025-07-17WarningsExact identifier
application number: M018
SilkTearsGLYCERIN OPHTHALMIC SOLUTIONSilkTears3866e2c1-051b-0b01-e063-6394a90af5cf2025-07-16WarningsExact identifier
application number: M018
Eyeleve MGDMINERAL OILBruder Healthcare145b66e2-00e1-410e-8539-e12ffc4f6f822025-07-15WarningsExact identifier
application number: M018
Quality Choice Eye Drops Redness ReliefTETRAHYDROZOLINE HCLChain Drug Marketing Assoc., Inc.38d2bc34-c6f0-a09c-e063-6394a90a69e12025-06-26WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Morning Star OTCdcd4164c-aa1e-4f07-ab2c-b439275629db2025-06-16WarningsExact identifier
application number: M018
Code Red Eye Drops MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
application number: M018
Biotrue Hydration BoostGLYCERINBausch & Lomb Incorporatede2621477-e6ee-4275-ba0a-939dca2550c42025-05-19WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
application number: M018
Splash Redness RelieverHYPROMELLOSE, NAPHAZOLINE HYDROCHLORIDELABORATORIOS SOPHIA, S.A. DE C.V.fa4140e6-dc80-da99-e053-6294a90a194f2025-05-09WarningsExact identifier
application number: M018
Vista Gonio Eye LubricantHYPROMELLOSE OPHTHALMIC SOLUTIONRed Wedding LLC00da365d-2988-9c9e-e063-6294a90a89312025-03-25WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDE TABLETBelleview Bioscience LLC31195e8f-d4de-9e37-e063-6294a90a41562025-03-24WarningsExact identifier
application number: M018
Leader Nighttime Relief Lubricant EyeLIGHT MINERAL OIL, WHITE PETROLATUMLEADER/Cardinal Health 110, Inc.308772fc-d6f6-da9f-e063-6394a90a41db2025-03-12WarningsExact identifier
application number: M018
Clear Eyes Maximum Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINPrestige Brands Holdings, Inc.c3b0e344-68dd-4c35-bf46-744e612a5b152025-02-28WarningsExact identifier
application number: M018
Blink Nourish Dry EyeGLYCERINBausch & Lomb Incorporatedcf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a42025-02-25WarningsExact identifier
application number: M018
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
application number: M018
Hydropure Lubricating Eye DropsGLYCERINOTE North America17f5b6e5-dc14-45c7-e063-6294a90af43d2025-02-14WarningsExact identifier
application number: M018
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact 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