Eye Wash

Product NDC: 0904-5377
Requested package NDC: 0904-5377-20
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0904-5377	0904-5377-20	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`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 NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5377-20	ML - Milliliter	0904-5377	9c60b3db-40af-42b7-88e0-ed4da8bfdde7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
WATER	ACTIVE INGREDIENT	059QF0KO0R	EYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]	2
WATER	ACTIVE MOIETY	059QF0KO0R	EYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]	2
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	EYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	EYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	EYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]	2
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	EYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	EYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	EYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]	2
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	EYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]	2
WATER	ACTIVE INGREDIENT	059QF0KO0R	EYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
WATER	ACTIVE MOIETY	059QF0KO0R	EYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	EYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	EYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	EYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	EYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	EYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	EYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	EYE WASH (WATER) SOLUTION [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
059QF0KO0R	WATER	7732-18-5	WATER

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5377-20	00904537720	1 BOTTLE, PLASTIC in 1 CARTON (0904-5377-20) > 118 mL in 1 BOTTLE, PLASTIC	2010-08-31	2021-09-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Major Pharmaceuticals	2020-01-03	HUMAN OTC DRUG LABEL	3
Drug Facts	A-S Medication Solutions	2018-01-18	HUMAN OTC DRUG LABEL	8
Drug Facts	Lake Erie Medical DBA Quality Care Products LLC	2015-08-03	HUMAN OTC DRUG LABEL	1