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 20 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clear Eyes Natural Tears	POLYVINYL ALCOHOL AND POVIDONE	Prestige Brands Holdings, Inc.	efba3eb0-798d-4635-b19b-4970e45b3cc9	2024-04-01	Warnings	Exact identifier application number: M018
Polyvinyl Alcohol	POLYVINYL ALCOHOL	A-S Medication Solutions	c77589fd-f68d-48b7-bd12-51f6b4cc9402	2024-03-20	Warnings	Exact identifier application number: M018
REFRESH CLASSIC	POLYVINYL ALCOHOL, POVIDONE	A-S Medication Solutions	3bf6193c-56db-45ad-844c-58eb8c33cba9	2024-03-14	Warnings	Exact identifier application number: M018
GOODSENSE ARTIFICIAL TEARS	POLYVINYL ALCOHOL	Proficient Rx LP	f29c792c-6cb2-449f-b97d-6304a58dec2a	2024-02-01	Warnings	Exact identifier application number: M018
GoodSense Artifical Tears	POLYVINYL ALCOHOL, AND POVIDONE	Proficient Rx LP	cd24da78-fd90-4a9c-8e5f-f7fc56ec0fc9	2024-02-01	Warnings	Exact identifier application number: M018
GENTEAL TEARS	DEXTRAN 70, GLYCERIN, HYPROMELLOSE	A-S Medication Solutions	a2b715e9-332d-4f0b-b8e5-ebc000681586	2024-01-21	Warnings	Exact identifier application number: M018
Visine Red Eye Hydrating Comfort, CVP	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400 SOLUTION/ DROPS	Lil' Drug Store Products, Inc.	0f50bcc8-3658-8c2c-e063-6294a90a8e13	2024-01-19	Warnings	Exact identifier application number: M018
Fendall 2000 Pure Flow	PURIFIED WATER	Honeywell Safety Products USA, Inc.	b56ef662-fec2-4d94-e053-2995a90aba2b	2024-01-06	Warnings	Exact identifier application number: M018
Exchange Select Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HCL	Army and Air Force Exchange Service	318bc025-c936-a066-e063-6294a90a4712	2024-01-01	Warnings	Exact identifier application number: M018
Kroger Eye Drops Original	TETRAHYDROZOLINE HCL	The Kroger Co.	318c17a1-fe08-508b-e063-6394a90a2e08	2024-01-01	Warnings	Exact identifier application number: M018
HEB Original Eye Drops	TETRAHYDROZOLINE HCL	HEB Grocery Company, LP	318cb457-bb2d-a1ee-e063-6294a90a8019	2024-01-01	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops Multi-Symptom Relief	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Discount Drug Mart, Inc.	318dc92a-0707-d6a4-e063-6294a90ab78a	2024-01-01	Warnings	Exact identifier application number: M018
Kroger Eye Drops Redness Relief	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	The Kroger Co.	318dea21-2656-36a3-e063-6294a90ac9c4	2024-01-01	Warnings	Exact identifier application number: M018
Harris Teeter Eye Drops Original	TETRAHYDROZOLINE HCL	Harris Teeter, LLC.P	31a1b962-27ad-97b1-e063-6294a90a77f1	2024-01-01	Warnings	Exact identifier application number: M018
CVP Sterile Eye Drops	TETRAHYDROZOLINE HCL	Salado Sales, Inc.	31a216f8-28e9-ec8f-e063-6394a90aec49	2024-01-01	Warnings	Exact identifier application number: M018
Equaline Sterile Eye Drops	TETRAHYDROZOLINE HCL	United Natural Foods, Inc.	31a25efb-a627-1a13-e063-6394a90a2ca3	2024-01-01	Warnings	Exact identifier application number: M018
Best Choice Eye Drops Original	TETRAHYDROZOLINE HCL	Valu Merchandisers Company	31a2a42a-bcfe-4f22-e063-6294a90ac60e	2024-01-01	Warnings	Exact identifier application number: M018
Discount Drug Mart Eye Drops Original	TETRAHYDROZOLINE HCL	Discount Drug Mart, Inc.	31a2efb2-3924-6a12-e063-6394a90ab0e2	2024-01-01	Warnings	Exact identifier application number: M018
Equaline Redness Relief Lubricant Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	United Natural Foods, Inc	31a30b00-9f4b-717a-e063-6394a90a8a87	2024-01-01	Warnings	Exact identifier application number: M018
Harris Teeter Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Harris Teeter, LLC.	31a3d575-10f1-5feb-e063-6294a90ac478	2024-01-01	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