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 18 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OASIS Tears Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.d9d71b1d-82a6-42e7-9ef2-2d041daef9362024-12-23WarningsExact identifier
application number: M018
Ancient Secrets Breathe AgainSODIUM CHLORIDELOTUS BRANDS, INC.c6d2bab0-d363-4c09-a71b-ae15db915b372024-12-18WarningsExact identifier
application number: M018
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMMEDTECH PRODUCTS INC77f504c1-b8e0-4371-ac3e-9d453d84714b2024-12-13WarningsExact identifier
application number: M018
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDMEDTECH PRODUCTS INCf1845041-9d8d-42a0-a2cb-68def7a5aac72024-12-13WarningsExact identifier
application number: M018
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
application number: M018
Systane NighttimeMINERAL OIL AND WHITE PETROLATUMAlcon Laboratories, Inc.4689c59c-5721-3f91-6c85-e41501998fd02024-12-05WarningsExact identifier
application number: M018
GenTeal Tears NIGHT-TIMEMINERAL OIL, WHITE PETROLATUMAlcon Laboratories, Inc.9d5998a7-4f59-4293-87da-8419650a524d2024-12-05WarningsExact identifier
application number: M018
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
Clear Eyes Cooling Redness ReliefGLYCERIN AND NAPHAZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.38d14e99-e4c8-431b-b106-578eeb38bf3c2024-10-25WarningsExact identifier
application number: M018
ndc (product): 67172-393
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

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