Eyewash Station Additive Concentrate

Product NDC: 78641-785
11-digit product format: 786410785
Labeler code: 78641
Product ID: 78641-785_56b96cad-c6d1-3ad9-e063-6394a90ab92a
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorhexidine gluconate and Propylene Glycol
Dosage form: LIQUID
Route: OPHTHALMIC
Labeler: Global Equipment Company
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-03-05
Substance: CHLORHEXIDINE GLUCONATE; PROPYLENE GLYCOL
Active strength: 145.6; 280 kg/2800L; kg/2800L
Pharmacologic classes: Decreased Cell Wall Integrity [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78641-785-63	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78641-785-63	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78641-785-63	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78641-785-63	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78641-785-63	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	78641-785-63	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	78641-785-63	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Eyewash Station Additive Concentrate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORHEXIDINE GLUCONATE	145.6 kg/2800L
PROPYLENE GLYCOL	280 kg/2800L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MOR84MUD8E	Internal UNII lookup
6DC9Q167V3	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
bc93a1e8-aa3c-6735-e053-2995a90ad6e8	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
78641-785-63	2025-01-30	C162847	48780-1	2cef2736-85cf-d83d-e063-dadaa90ab31f	EYEWASH STATION ADDITIVE CONCENTRATE

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rugby Lubricating Drops	POLYVINYL ALCOHOL	A-S Medication Solutions	f2e26f85-4081-425b-9c81-ac2a079a5743	2023-11-10	Warnings	Exact identifier application number: M018
Saline	NASAL	GERI-CARE PHARMACEUTICAL CORP	d293cc13-4043-0d58-e053-2995a90a3fbc	2023-10-24	Warnings	Exact identifier application number: M018
Eyeganics Organic Tears	GLYCERIN	Eyeganics LLC	42470af7-a3ae-4e14-88e0-04cd92db4b37	2023-10-13	Warnings	Exact identifier application number: M018
Refresh Digital PF	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80	Allergan, Inc.	97e83e68-6374-4df4-93f6-d707fc32748d	2022-11-28	Warnings	Exact identifier application number: M018
Refresh Digital	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	b2bd34d4-fab9-4f4b-9be2-5d30b55f5b81	2022-11-28	Warnings	Exact identifier application number: M018
REFRESH OPTIVE	CARBOXYMETHYLCELLULOSE SODIUM AND GLYCERIN	Allergan, Inc.	7f8d88af-fd3b-4138-af61-f24c59ccebd7	2022-09-23	Warnings	Exact identifier application number: M018
REFRESH OPTIVE Advanced	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80	Allergan, Inc.	ebd0839e-2e1d-4e0e-986c-19f1f5c76358	2022-09-15	Warnings	Exact identifier application number: M018
REFRESH OPTIVE Advanced	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80	Allergan, Inc.	aaa943e4-7c38-4c5a-b7c0-5a656d8cafc0	2022-09-01	Warnings	Exact identifier application number: M018
REFRESH TEARS	CARBOXYMETHYLCELLULOSE SODIUM	Allergan, Inc.	329d1fe0-4432-4565-b7b1-65666bd86526	2022-06-30	Warnings	Exact identifier application number: M018
REFRESH Optive Mega-3	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80	Allergan, Inc.	c5f2b3f2-2071-45bd-a010-67f848bc0233	2022-06-30	Warnings	Exact identifier application number: M018
REFRESH P.M.	MINERAL OIL, PETROLATUM	Allergan, Inc.	24365d64-cd94-41cc-a7e1-033102d98114	2022-06-30	Warnings	Exact identifier application number: M018
REFRESH PLUS	CARBOXYMETHYLCELLULOSE SODIUM	Allergan, Inc.	0f6a4b4b-cde6-4518-84b5-ce997f1154a7	2022-06-28	Warnings	Exact identifier application number: M018
CIRCLE K sterile eye drops	TETRAHYDROZOLINE HCL	Lil' Drug Store Products, Inc.	2c0e106c-16f6-ff4e-e063-6294a90a7dbb	2018-07-30	Warnings	Exact identifier application number: M018
Lil Drug Store Sterile Eye Drops Redness Reliever	TETRAHYDROZOLINE HCL	Lil' Drug Store Products, Inc.	2c0ea35c-ac52-1043-e063-6394a90a061c	2018-04-30	Warnings	Exact identifier application number: M018

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MOR84MUD8E	CHLORHEXIDINE GLUCONATE	18472-51-0	CHLORHEXIDINE GLUCONATE
6DC9Q167V3	PROPYLENE GLYCOL	57-55-6	PROPYLENE GLYCOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
78641-785-63	78641078563	.236 L in 1 BOTTLE, PLASTIC (78641-785-63)	2021-03-05	0000-00-00	No	No	Current
78641-785-67	78641078567	.236 L in 1 BOTTLE, PLASTIC (78641-785-67)	2021-03-05	0000-00-00	No	No	Current
78641-785-68	78641078568	.236 L in 1 BOTTLE, PLASTIC (78641-785-68)	2021-03-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EYEWASH STATION ADDITIVE CONCENTRATE	Global Equipment Company \| Niagara Pharmaceuticals Inc.	2026-07-16	HUMAN OTC DRUG LABEL	4