ULINE Eyewash

Product NDC
65785-125
11-digit product format
657850125
Labeler code
65785
Product ID
65785-125_445cc5b0-291c-a344-e063-6394a90a0298
Type
HUMAN OTC DRUG
Nonproprietary name
Eyewash
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Niagara Pharmaceuticals Inc.
Application
NDA022305
Marketing category
NDA
Marketing start
2024-04-01
Substance
WATER
Active strength
465 mL/473mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ULINE Eyewash
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WATER465 mL/473mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii059QF0KO0R
Rxcui1151101

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65785-125-01ULINE Eyewash473 mL in 1 BOTTLE, UNIT-DOSESOLUTION4734
65785-125-02ULINE Eyewash946 mL in 1 BOTTLE, UNIT-DOSESOLUTION9464

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65785-125ULINE EYEWASH (EYEWASH) SOLUTION [NIAGARA PHARMACEUTICALS INC.]1Current NDC, 2 package rows20250209_2d7f22d2-320b-6af1-e063-6294a90addc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1151101water 98.3 % Ophthalmic Irrigation SolutionPSN2d7f22d2-320b-6af1-e063-6294a90addc64
1151101water 983 MG/ML Ophthalmic Irrigation SolutionSCD2d7f22d2-320b-6af1-e063-6294a90addc64
1151101water 98.3 % Ophthalmic Irrigation SolutionSY2d7f22d2-320b-6af1-e063-6294a90addc64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65785-125-0165785012501473 mL in 1 BOTTLE, UNIT-DOSE (65785-125-01) 473 ml2024-04-01NoNoHistorical
65785-125-0265785012502946 mL in 1 BOTTLE, UNIT-DOSE (65785-125-02) 946 ml2024-04-01NoNoHistorical