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 23 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Better Living Brands LLC	5d7228ce-f108-4cc2-9aec-8b4548c3a155	2023-12-20	Warnings	Exact identifier application number: M018
Target Eye Drops Maximum Redness Relief Eye	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Target Corporation	1b26cd3b-4a05-4623-b320-01f22b3106ff	2023-12-20	Warnings	Exact identifier application number: M018
Kroger High Performance Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Kroger	d2aa8963-1922-02f3-e053-2a95a90a7d93	2023-12-20	Warnings	Exact identifier application number: M018
Kroger Eye Drops Seasonal Relief	TETRAHYDROZOLINE HCL, ZINC SULFATE	Kroger	f6829be4-e3b7-7ff2-e053-2995a90a80fc	2023-12-20	Warnings	Exact identifier application number: M018
Rite Aid Multi-Symptom Relief Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Rite Aid Corporation	efa7d208-9d42-13c7-e053-2a95a90a11b3	2023-12-20	Warnings	Exact identifier application number: M018
Signature Care Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	Better Living Brands LLC	ea358e01-f03e-454b-bae1-6c83da44c369	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Original Eye Drops	TETRAHYDROZOLINE HCL	Topco Associates LLC	9c61a56a-c1a9-2846-e053-2995a90a755b	2023-12-20	Warnings	Exact identifier application number: M018
Signature Care Eye Drops A.C.	TETRAHYDROZOLINE HCL, ZINC SULFATE	Better Living Brands LLC	f685aca4-93d0-26d9-e053-2995a90a6e51	2023-12-20	Warnings	Exact identifier application number: M018
Kroger Lubricant Eye	CARBOXYMETHYLCELLULOSE SODIUM	The Kroger Co.	046f4ebc-d8f9-4755-b6ba-790fe86f3128	2023-12-20	Warnings	Exact identifier application number: M018
Kroger Eye Drops Advanced Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	Kroger Company	f7ad77fc-d890-25b9-e053-6394a90a2b12	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Dry Eye Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Topco Associates LLC	9c617e34-fc66-1a5b-e053-2995a90ace2c	2023-12-20	Warnings	Exact identifier application number: M018
Equaline Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE	United Natural Foods, Inc.	f7602789-179a-edfc-e053-6294a90a0844	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Ultra Itch Relief Astringent Eye Drops	TETRAHYDROZOLINE HCL, ZINC SULFATE	Topco Associates LLC	9c617e34-fc64-1a5b-e053-2995a90ace2c	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Topco Associates LLC	9c614c0e-5862-682f-e053-2a95a90abc09	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Health Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Topco Assoc LLC	9c6284f9-00bb-37b5-e053-2a95a90ae2ee	2023-12-20	Warnings	Exact identifier application number: M018
HEB Dry Eye Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	HEB	f80023cf-8e42-780a-e053-6294a90a66cd	2023-12-20	Warnings	Exact identifier application number: M018
TopCare Health Advanced Moisturizing Plus Redness Relief	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Topco Associates LLC	9c6193a6-d822-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier application number: M018
Topcare Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Topco Assoc LLC	9c6193a6-d824-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier application number: M018
HEB Lubricant Eye Drops	CARBOXYMETHYLCELLULOSE SODIUM	HEB	5d522e4d-d647-486f-a947-25c14b1417fa	2023-12-20	Warnings	Exact identifier application number: M018
HEB A.C. Eye Drops	TETRAHYDROZOLINE HCL, ZINC SULFATE	HEB Grocery Company., LP	f680a8c1-dc91-7a52-e053-2a95a90a571e	2023-12-20	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