First Aid Direct Buffered Eyewash Sterile Isotonic

Product NDC: 42961-300
Requested package NDC: 42961-300-20
11-digit product format: 429610300
Labeler code: 42961
Product ID: 42961-300_0bc645f8-dc76-4264-a786-94863877ad4f
Type: HUMAN OTC DRUG
Nonproprietary name: Water
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Cintas Corporation
Application: part349
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-10-01
Marketing end: 0000-00-00
Substance: WATER
Active strength: 1 mL/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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	42961-300	42961-300-20	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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42961-300-20	2025-02-12	C162847	48780-1	1030e365-29d6-111a-e063-dadaa90a10e2	First Aid Direct Buffered Eyewash Sterile Isotonic Solution
42961-300-20	2024-01-30	C162847	48780-1	1030e365-29d6-111a-e063-dadaa90a10e2	First Aid Direct Buffered Eyewash Sterile Isotonic Solution

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Water	ACTIVE INGREDIENT	059QF0KO0R	FIRST AID DIRECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]	1
Water	ACTIVE MOIETY	059QF0KO0R	FIRST AID DIRECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]	1
Benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	FIRST AID DIRECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]	1
Edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	FIRST AID DIRECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]	1
Sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	FIRST AID DIRECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]	1
Sodium phosphate, Dibasic, Heptahydrate	INACTIVE INGREDIENT	70WT22SF4B	FIRST AID DIRECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]	1
Sodium phosphate, Monobasic, Monohydrate	INACTIVE INGREDIENT	593YOG76RN	FIRST AID DIRECT BUFFERED EYEWASH STERILE ISOTONIC (WATER) SOLUTION [CINTAS]	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
42961-300-20	42961030020	4 BOTTLE, UNIT-DOSE in 1 BOX, UNIT-DOSE (42961-300-20) > 30 mL in 1 BOTTLE, UNIT-DOSE	2011-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
First Aid Direct Buffered Eyewash Sterile Isotonic Solution	Cintas Corporation \| Horizon Pharmaceuticals, Inc.	2021-01-11	HUMAN OTC DRUG LABEL	3