FDA.reportPublic FDA data

OCUFRESH

Product NDC
64108-313
11-digit product format
641080313
Labeler code
64108
Product ID
64108-313_b91fb96f-4fa4-462b-a8c5-c07d2eb9a42f
Type
HUMAN OTC DRUG
Nonproprietary name
Water
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Optics Laboratory Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-15
Substance
WATER
Active strength
.988 mL/mL
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
OCUFRESH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WATER.988 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
059QF0KO0RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1489376Internal RxNorm lookup
1489378Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b8e477a9-66b9-496b-92fb-3d4bbd7b36b5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64108-313-01OCUFRESH20 mL in 1 BOTTLELIQUID2011
64108-313-06OCUFRESH6 in 1 PACKAGELIQUID611
64108-313-24OCUFRESH24 in 1 PACKAGELIQUID2411
64108-313-60OCUFRESH60 in 1 PACKAGELIQUID6011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WATERACTIVE INGREDIENT059QF0KO0ROCUFRESH (WATER) LIQUID [OPTICS LABORATORY INC.]2
WATERACTIVE MOIETY059QF0KO0ROCUFRESH (WATER) LIQUID [OPTICS LABORATORY INC.]2
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7OCUFRESH (WATER) LIQUID [OPTICS LABORATORY INC.]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4OCUFRESH (WATER) LIQUID [OPTICS LABORATORY INC.]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOOCUFRESH (WATER) LIQUID [OPTICS LABORATORY INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOCUFRESH (WATER) LIQUID [OPTICS LABORATORY INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64108-313OCUFRESH (WATER) LIQUID [OPTICS LABORATORY INC.]10Current NDC, Legacy NDC, 4 package rows20241218_b8e477a9-66b9-496b-92fb-3d4bbd7b36b5.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 7 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vis Guard Lubricant Eye DropsPOLYVINYL ALCOHOL 1.4%Ulai Health LLCe9b0ed39-60c8-1093-e053-2a95a90a705b2026-01-13WarningsExact identifier
application number: M018
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb4697319-438e-2ec8-e053-2a95a90abb562026-01-08WarningsExact identifier
application number: M018
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb478a695-ded0-2e5f-e053-2995a90ac45e2026-01-08WarningsExact identifier
application number: M018
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
application number: M018
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
application number: M018
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
application number: M018
Polyvinyl Alcohol Eye Drops 1,4 % w/vPOLYVINYL ALCOHOL EYE DROPS 1,4 % W/VAurolabe8e09719-6e06-612b-e053-2995a90a79fc2026-01-08WarningsExact identifier
application number: M018
AuroviscHYPROMELLOSE OPHTHALMIC SOLUTION 2% W/VAurolabe9100312-b105-50a6-e053-2a95a90ac31f2026-01-08WarningsExact identifier
application number: M018
TheraTears Dry and TiredCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC02b70e2d-8159-4637-a282-9eac1468e7862026-01-07WarningsExact identifier
application number: M018
VISTA Hypromellose Dry Eye ReliefHYPROMELLOSERed Wedding LLCb2c4954c-ed53-778a-e053-2a95a90ae0d02026-01-01WarningsExact identifier
application number: M018
Colirio Ojo De Aguila Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEGrandall Distributing Co., Inc.31aa07e9-0cc9-2a77-e063-6394a90a4b9d2025-12-31WarningsExact identifier
application number: M018
Value Health by Prodose Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Prodose, Inc.3fafa362-a8a6-3f91-e063-6394a90a98b32025-12-31WarningsExact identifier
application number: M018
Signature Care Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands LLC6f1f4f58-3208-4b06-9afb-c4beeed093142025-12-30WarningsExact identifier
application number: M018
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporation6c449374-8847-4c4a-9073-1951ff31d4042025-12-30WarningsExact identifier
application number: M018
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporationddc15dac-fbd8-42fa-80db-79f49fc6b9eb2025-12-30WarningsExact identifier
application number: M018
Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMAmerisource Bergen Drug Corp.fd6b2be8-7e00-3765-e053-6294a90a40612025-12-30WarningsExact identifier
application number: M018
Rugby Carboxymethylcellulose Sodium 0.5% Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratoriesfb84fc0b-9a62-812a-e053-6394a90aba0a2025-12-30WarningsExact identifier
application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye DropsPOLYVINYL ALCOHOLRugby Laboratories081673b2-5c74-1200-e063-6394a90ae3632025-12-30WarningsExact identifier
application number: M018
Medi-First Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMUnifirst First Aid Corporationa4e651cc-adf0-af9e-e053-2995a90ace5a2025-12-30WarningsExact identifier
application number: M018
Green Guard Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMUniFirst First Aid Corporationc3f04fdb-9fc1-797d-e053-2995a90afe802025-12-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1489378OcuFresh 98.8 % Ophthalmic Irrigation SolutionPSNb8e477a9-66b9-496b-92fb-3d4bbd7b36b511
1489376Water 98.8 % Ophthalmic Irrigation SolutionPSNb8e477a9-66b9-496b-92fb-3d4bbd7b36b511
1489378water 988 MG/ML Ophthalmic Irrigation Solution [OcuFresh]SBDb8e477a9-66b9-496b-92fb-3d4bbd7b36b511
1489376water 988 MG/ML Ophthalmic Irrigation SolutionSCDb8e477a9-66b9-496b-92fb-3d4bbd7b36b511
1489378OcuFresh 98.8 % Ophthalmic Irrigation SolutionSYb8e477a9-66b9-496b-92fb-3d4bbd7b36b511
1489378OcuFresh 988 MG/ML Ophthalmic Irrigation SolutionSYb8e477a9-66b9-496b-92fb-3d4bbd7b36b511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64108-313-016410803130120 mL in 1 BOTTLE (64108-313-01) 20 ml2014-01-150000-00-00NoNoCurrent
64108-313-06641080313066 BOTTLE in 1 PACKAGE (64108-313-06) / 20 mL in 1 BOTTLE (64108-313-01) 6 bottle2014-01-150000-00-00NoNoCurrent
64108-313-246410803132424 BOTTLE in 1 PACKAGE (64108-313-24) / 20 mL in 1 BOTTLE (64108-313-01) 24 bottle2014-01-150000-00-00NoNoCurrent
64108-313-606410803136060 BOTTLE in 1 PACKAGE (64108-313-60) / 20 mL in 1 BOTTLE (64108-313-01) 60 bottle2014-01-150000-00-00NoNoCurrent