Eye Wash

Product NDC
0904-5377
11-digit product format
009045377
Labeler code
0904
Product ID
0904-5377_aa44fa06-0b7f-46b1-90cb-d90f18142654
Type
HUMAN OTC DRUG
Nonproprietary name
water
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Major Pharmaceuticals
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-08-31
Marketing end
2021-09-26
Substance
WATER
Active strength
99 mL/100mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-5377DDiscontinued by firm2026-10-05
excluded packagepackage0904-53770904-5377-20DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-5377-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-5377-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-5377-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-5377-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-5377-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-5377-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-5377-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-5377-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-5377-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-5377-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-5377-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-5377-20557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5377-20ML - Milliliter0904-53779c60b3db-40af-42b7-88e0-ed4da8bfdde712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WATERACTIVE INGREDIENT059QF0KO0REYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]2
WATERACTIVE MOIETY059QF0KO0REYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4EYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBEYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOEYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IEYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BEYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]2
WATERACTIVE INGREDIENT059QF0KO0REYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
WATERACTIVE MOIETY059QF0KO0REYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4EYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBEYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOEYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IEYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BEYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-5377-20009045377201 BOTTLE, PLASTIC in 1 CARTON (0904-5377-20) > 118 mL in 1 BOTTLE, PLASTIC2010-08-312021-09-26NoNoCurrent