Eyewash Station Additive Concentrate

Product NDC: 65785-034
11-digit product format: 657850034
Labeler code: 65785
Product ID: 65785-034_445cd72e-831c-98c4-e063-6294a90a7bdc
Type: HUMAN OTC DRUG
Nonproprietary name: Chlorhexidine gluconate and Propylene Glycol
Dosage form: LIQUID
Route: OPHTHALMIC
Labeler: Niagara Pharmaceuticals Inc.
Application: M018
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-11-15
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	65785-034		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65785-034	65785-034-01	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`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
362a6b6d-862d-4322-87a8-5b3a07fbe174	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68	Product name	1	20160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65785-034-01	2023-02-21	C162847	48780-1	f386c64a-201f-0266-e053-dadaa90a7c1a	EYEWASH STATION ADDITIVE CONCENTRATE
65785-034-01	2023-01-30	C162847	48780-1	f386c64a-201f-0266-e053-dadaa90a7c1a	EYEWASH STATION ADDITIVE CONCENTRATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65785-034-01	Eyewash Station Additive Concentrate	0.236 L in 1 BOTTLE, UNIT-DOSE	LIQUID	0.236		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Chlorhexidine gluconate	ACTIVE INGREDIENT	MOR84MUD8E	EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]	1
Propylene Glycol	ACTIVE INGREDIENT	6DC9Q167V3	EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]	1
Chlorhexidine	ACTIVE MOIETY	R4KO0DY52L	EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]	1
Propylene Glycol	ACTIVE MOIETY	6DC9Q167V3	EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65785-034	EYEWASH STATION ADDITIVE CONCENTRATE (CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL) LIQUID [NIAGARA PHARMACEUTICALS INC.]	5	Current NDC, Legacy NDC, 1 package rows	20250115_362a6b6d-862d-4322-87a8-5b3a07fbe174.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 19 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eye Wash	WATER	Hubei Changjian Medical Products Co., Ltd.	d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea	2024-10-11	Warnings	Exact identifier application number: M018
Capasil Pain Relieving	MENTHOL, METHYL SALICYLATE	PureTek Corporation	b1a8e78c-57f0-1f3e-e053-2995a90acbd5	2024-10-01	Warnings	Exact identifier application number: M018
Mencylate Pain Relieving	MENTHOL, METHYL SALICYLATE	PureTek Corporation	f824de86-9492-2e6b-e053-6294a90a6f2a	2024-10-01	Warnings	Exact identifier application number: M018
Advanced Eye Relief/ Redness Maximum Relief	NAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSE	Bausch & Lomb Incorporated	3c11285a-7e86-4b47-b1ee-e7d59858087d	2024-09-25	Warnings	Exact identifier application number: M018
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	cc3d5bc8-9d3c-4c65-9e43-707a2db4081a	2024-09-25	Warnings	Exact identifier application number: M018
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	93fafa27-5031-4d95-b4b8-5574b7204ae2	2024-09-25	Warnings	Exact identifier application number: M018
Muro 128	SODIUM CHLORIDE	Bausch & Lomb Incorporated	454f337e-d897-46de-ab05-1c543a33061c	2024-09-25	Warnings	Exact identifier application number: M018
PURPOSE	OCTINOXATE, OCTISALATE AND OXYBENZONE	Bausch & Lomb Incorporated	a1e14135-b8da-4cee-8c5b-1893572f4de4	2024-09-25	Warnings	Exact identifier application number: M018
Soothe Night Time	WHITE PETROLATUM MINERAL OIL	Bausch & Lomb Incorporated	638d3c3f-9960-43da-956e-0e28c77f533e	2024-09-24	Warnings	Exact identifier application number: M018
blink tears	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	10fcf407-6eaf-4730-9ed0-9b7715cf5701	2024-09-20	Warnings	Exact identifier application number: M018
Soothe XP Preservative Free	LIGHT MINERAL OIL AND MINERAL OIL	Bausch & Lomb Incorporated	b254d885-6d49-4c95-b6be-cfdad49c85e6	2024-09-20	Warnings	Exact identifier application number: M018
blink gel tears	POLYETHYLENE GLYCOL 400	Bausch & Lomb Incorporated	6f7e06c3-204d-459a-af8f-c46be9ad0e8d	2024-09-20	Warnings	Exact identifier application number: M018
Soothe XP	LIGHT MINERAL OIL AND MINERAL OIL	Bausch & Lomb Incorporated	c0f053da-8d22-433e-a36e-79cf15ad387f	2024-09-20	Warnings	Exact identifier application number: M018
Soothe	GLYCERIN AND PROPYLENE GLYCOL	Bausch & Lomb Incorporated	fef002ea-c4bd-4486-a42e-1bbd9d73d28d	2024-09-20	Warnings	Exact identifier application number: M018
Leader Preservative-Free Ultra Lubricating Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Cardinal Health	2a2aa620-ca63-4698-88fd-fc263b8fa0d1	2024-09-07	Warnings	Exact identifier application number: M018
Eyesaline Emergency Eyewash	PURIFIED WATER	Honeywell Safety Products USA, Inc.	ad42a7e3-84ea-390d-e053-2a95a90a3a32	2024-06-14	Warnings	Exact identifier application number: M018
Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	NuCare Pharmaceuticals,Inc.	9c1c4911-908e-3c3c-e053-2995a90abcfc	2024-06-14	Warnings	Exact identifier application number: M018
Eyes Alive Eye Wash	WATER	RIVIERA PHARMA INC	081079f4-1c06-4054-b771-00fedaa666f6	2024-06-05	Warnings	Exact identifier application number: M018
Eyes Alive Lubricating	CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	RIVIERA PHARMA INC	b6966691-6884-438c-9f89-5924089226e1	2024-05-31	Warnings	Exact identifier application number: M018
Eye Wash	WATER	M-star (Hubei) Health&Care Products Co., Ltd.	71706039-e250-4f08-9687-71b2928c4e46	2024-04-01	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
65785-034-01	65785003401	.236 L in 1 BOTTLE, UNIT-DOSE (65785-034-01)	2011-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EYEWASH STATION ADDITIVE CONCENTRATE	Niagara Pharmaceuticals Inc. \| STERIS Applied Sterilization Technologies ULC \| Isomedix Operations Inc.	2025-11-24	HUMAN OTC DRUG LABEL	8