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 21 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Discount Drug Mart Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Discount Drug Mart, Inc.	31a98e6c-42df-6b56-e063-6294a90a3564	2024-01-01	Warnings	Exact identifier application number: M018
Harris Teeter Ultra Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Harris Teeter, LLC.	31ac6883-ffc6-39de-e063-6294a90a52dd	2024-01-01	Warnings	Exact identifier application number: M018
Exchange Select High Performance Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Army and Air Force Exchange Service	31ac8bd2-c2e9-6f2c-e063-6394a90adc72	2024-01-01	Warnings	Exact identifier application number: M018
CVS Health Fast Acting Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	CVS Pharmacy, Inc.	31addfd2-52f2-05b3-e063-6294a90a337f	2024-01-01	Warnings	Exact identifier application number: M018
Equate Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Wal-Mart Stores, Inc.	91fb8fb5-b871-4535-e053-2995a90a9b16	2023-12-23	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops Preservative-Free	CARBOXYMETHYLCELLULOSE SODIUM	Wal-Mart Stores, Inc.	9228a39b-38d2-1dfc-e053-2a95a90a3c90	2023-12-23	Warnings	Exact identifier application number: M018
Equate Restore Plus Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Walmart, Inc.	9e665ca2-4fa6-fdb4-e053-2a95a90abcca	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Eye Drops Advanced Moisturizer/Lubricant	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE	Strategic Sourcing Services LLC	0daa4e39-0447-44b6-a7d7-370b12bf9451	2023-12-23	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Wal-Mart Stores, Inc.	91f85a72-5270-e4db-e053-2995a90aeb21	2023-12-23	Warnings	Exact identifier application number: M018
Equate Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Wal-Mart Stores, Inc.	e32233ef-ea15-45b8-8e83-b658cf4c56a0	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Eye Drops Original Formula	TETRAHYDROZOLINE HCL	Strategic Sourcing Services LLC	33efa7e9-4c3a-4d72-af31-c5e35095c2ff	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Lubricant Eye Drops	POLYPROPYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	b117ff0a-1a48-4022-96e6-52bc45f056fc	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Strategic Sourcing Services LLC	043ccc34-44ee-416a-88bc-f247774e9075	2023-12-23	Warnings	Exact identifier application number: M018
Sunmark Lubricating Tears	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Strategic Sourcing Services LLC	58f0b6d7-6072-40fd-ba72-b3ed68834791	2023-12-23	Warnings	Exact identifier application number: M018
Leader Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Cardinal Health	8d9a4eec-bf0e-6c3b-e053-2995a90ae9aa	2023-12-23	Warnings	Exact identifier application number: M018
Leader Eye Wash	PURIFIED WATER	Cardinal Health	8d3ad11f-1945-f838-e053-2995a90a7aa5	2023-12-23	Warnings	Exact identifier application number: M018
Good Neighbor Pharmacy Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Amerisource Bergen Drug Corp.	fd2dc23f-6ccc-2644-e053-6294a90a889e	2023-12-23	Warnings	Exact identifier application number: M018
Rite Aid Eye Drops Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Rite Aid Corporation	fa1b5b66-9643-e9a7-e053-6394a90ae3cf	2023-12-23	Warnings	Exact identifier application number: M018
Signature Care Lubricant Eye Drops Long Lasting	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Better Living Brands, LLC	05a63929-fccd-2936-e063-6294a90aeac5	2023-12-23	Warnings	Exact identifier application number: M018
Meijer Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Meijer Distribution, Inc.	9feadde4-fbe5-0c9e-e053-2995a90a9b30	2023-12-22	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