FDA.reportPublic FDA data

Eyesaline Eyewash Concentrate

Product NDC
0498-2501
11-digit product format
004982501
Labeler code
0498
Product ID
0498-2501_2d90c8e8-f47a-3535-e063-6394a90af122
Type
HUMAN OTC DRUG
Nonproprietary name
Purified Water
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Honeywell Safety Products, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-04
Substance
WATER
Active strength
92.14 L/100L
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
Eyesaline Eyewash Concentrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WATER92.14 L/100L

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2704856Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d90c8e8-f479-3535-e063-6394a90af122Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0498-2501-01Eyesaline Eyewash Concentrate2.07 L in 1 BOTTLE, PLASTICLIQUID2.071
0498-2501-02Eyesaline Eyewash Concentrate5.32 L in 1 BOTTLE, PLASTICLIQUID5.321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0498-2501EYESALINE EYEWASH CONCENTRATE (PURIFIED WATER) LIQUID [HONEYWELL SAFETY PRODUCTS, INC.]1Current NDC, 2 package rows20250210_2d90c8e8-f479-3535-e063-6394a90af122.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 25 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Lubricating DropsPOLYVINYL ALCOHOLA-S Medication Solutionsf2e26f85-4081-425b-9c81-ac2a079a57432023-11-10WarningsExact identifier
application number: M018
SalineNASALGERI-CARE PHARMACEUTICAL CORPd293cc13-4043-0d58-e053-2995a90a3fbc2023-10-24WarningsExact identifier
application number: M018
Eyeganics Organic TearsGLYCERINEyeganics LLC42470af7-a3ae-4e14-88e0-04cd92db4b372023-10-13WarningsExact identifier
application number: M018
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
application number: M018
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
application number: M018
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
application number: M018
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
application number: M018
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
application number: M018
REFRESH TEARSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.329d1fe0-4432-4565-b7b1-65666bd865262022-06-30WarningsExact identifier
application number: M018
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
application number: M018
REFRESH P.M.MINERAL OIL, PETROLATUMAllergan, Inc.24365d64-cd94-41cc-a7e1-033102d981142022-06-30WarningsExact identifier
application number: M018
REFRESH PLUSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.0f6a4b4b-cde6-4518-84b5-ce997f1154a72022-06-28WarningsExact identifier
application number: M018
CIRCLE K sterile eye dropsTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0e106c-16f6-ff4e-e063-6294a90a7dbb2018-07-30WarningsExact identifier
application number: M018
Lil Drug Store Sterile Eye Drops Redness RelieverTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0ea35c-ac52-1043-e063-6394a90a061c2018-04-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2704856water 92.14 % Ophthalmic Irrigation SolutionPSN2d90c8e8-f479-3535-e063-6394a90af1221
2704856water 921 MG/ML Ophthalmic Irrigation SolutionSCD2d90c8e8-f479-3535-e063-6394a90af1221
2704856water 92.1 % Ophthalmic Irrigation SolutionSY2d90c8e8-f479-3535-e063-6394a90af1221
2704856water 92.14 % Ophthalmic Irrigation SolutionSY2d90c8e8-f479-3535-e063-6394a90af1221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0498-2501-01004982501012.07 L in 1 BOTTLE, PLASTIC (0498-2501-01) 2.07 l2025-02-04NoNoCurrent
0498-2501-02004982501025.32 L in 1 BOTTLE, PLASTIC (0498-2501-02) 5.32 l2025-02-04NoNoCurrent