FDA.reportPublic FDA data

Clear Eyes Redness Relief

Product NDC
67172-797
11-digit product format
671720797
Labeler code
67172
Product ID
67172-797_5b2797a9-d81e-635c-e063-6294a90a0cc6
Type
HUMAN OTC DRUG
Nonproprietary name
Naphazoline Hydrochloride and Glycerin
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Prestige Brands Holdings, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-04-27
Substance
NAPHAZOLINE HYDROCHLORIDE; GLYCERIN
Active strength
.12; 2.5 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
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 packagepackage67172-79767172-797-06DDiscontinued by firm2026-10-15

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 Redness Relief
Listing expiration
2027-12-31

Active Ingredients#

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

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
67172-797-01Clear Eyes Redness Relief1 in 1 BOXLIQUID113
67172-797-01Clear Eyes Redness Relief30 mL in 1 BOTTLELIQUID3013
67172-797-06Clear Eyes Redness Relief1 in 1 CARTONLIQUID113
67172-797-06Clear Eyes Redness Relief6 mL in 1 BOTTLE, DROPPERLIQUID613
67172-797-15Clear Eyes Redness Relief15 mL in 1 BOTTLE, DROPPERLIQUID1513
67172-797-15Clear Eyes Redness Relief1 in 1 CARTONLIQUID113

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67172-797CLEAR EYES REDNESS RELIEF (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) LIQUID CLEAR EYES REDNESS RELIEF HANDY POCKET PAL (NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN) LIQUID [PRESTIGE BRANDS HOLDINGS, INC.]13Current NDC, Legacy NDC, 6 package rows20250426_a26ef66e-2def-4c98-9959-d40d4cfe3108.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
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
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionPSNa26ef66e-2def-4c98-9959-d40d4cfe310813
1046700glycerin 2.5 MG/ML / naphazoline hydrochloride 0.12 MG/ML Ophthalmic SolutionSCDa26ef66e-2def-4c98-9959-d40d4cfe310813
1046700glycerin 0.25 % / naphazoline HCl 0.012 % Ophthalmic SolutionSYa26ef66e-2def-4c98-9959-d40d4cfe310813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67172-797-01671720797011 BOTTLE in 1 BOX (67172-797-01) / 30 mL in 1 BOTTLE1 bottle2011-04-270000-00-00NoNoCurrent
67172-797-06671720797061 BOTTLE, DROPPER in 1 CARTON (67172-797-06) > 6 mL in 1 BOTTLE, DROPPER2011-04-270000-00-00NoNoCurrent
67172-797-15671720797151 BOTTLE, DROPPER in 1 CARTON (67172-797-15) / 15 mL in 1 BOTTLE, DROPPER2011-04-270000-00-00NoNoCurrent