PUR-WASH

Product NDC: 65785-162
Requested package NDC: 65785-162-01
11-digit product format: 657850162
Labeler code: 65785
Product ID: 65785-162_445cd72e-831e-98c4-e063-6294a90a7bdc
Type: HUMAN OTC DRUG
Nonproprietary name: Water
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Niagara Pharmaceuticals Inc.
Application: NDA022305
Marketing category: NDA
Marketing start: 2011-09-12
Substance: WATER
Active strength: 929 g/946mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	65785-162	65785-162-01	D	Discontinued by firm		2026-10-16

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022305-001	PUR-WASH	PURIFIED WATER	98.3%	SOLUTION / OPHTHALMIC		RLD, RS	2011-09-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`3a93d1ddd44b…`

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: PUR-WASH
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
WATER	929 g/946mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
059QF0KO0R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1151101	Internal RxNorm lookup
1424605	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
777e1559-786f-8d54-e053-2991aa0aa98d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65785-162-01	PUR-WASH	236 mL in 1 BOTTLE, UNIT-DOSE	SOLUTION	236		6
65785-162-02	PUR-WASH	473 mL in 1 BOTTLE, UNIT-DOSE	SOLUTION	473		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
WATER	ACTIVE INGREDIENT	059QF0KO0R	PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH (PURIFIED WATER 98.3%) SOLUTION [ACME UNITED CORPORATION]	1
WATER	ACTIVE MOIETY	059QF0KO0R	PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH (PURIFIED WATER 98.3%) SOLUTION [ACME UNITED CORPORATION]	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH (PURIFIED WATER 98.3%) SOLUTION [ACME UNITED CORPORATION]	1
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH (PURIFIED WATER 98.3%) SOLUTION [ACME UNITED CORPORATION]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH (PURIFIED WATER 98.3%) SOLUTION [ACME UNITED CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65785-162	PUR-WASH (WATER) SOLUTION [NIAGARA PHARMACEUTICALS INC.]	2	Current NDC, Legacy NDC, 2 package rows	20250130_777e1559-786f-8d54-e053-2991aa0aa98d.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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eyewash	EYEWASH	Global Equipment Company	c4f78121-4668-2e0c-e053-2995a90ab6c6	2021-06-17	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305
Dynamic Eyewash with Eyecup	WATER	Dynamic Safety International	7d3af0f4-0e1f-9ea5-e053-2991aa0af7a2	2018-12-17	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
059QF0KO0R	WATER	7732-18-5	WATER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1424605	Pur-Wash 98.3 % Ophthalmic Irrigation Solution	PSN	777e1559-786f-8d54-e053-2991aa0aa98d	6
1151101	water 98.3 % Ophthalmic Irrigation Solution	PSN	777e1559-786f-8d54-e053-2991aa0aa98d	6
1424605	water 983 MG/ML Ophthalmic Irrigation Solution [Pur-Wash]	SBD	777e1559-786f-8d54-e053-2991aa0aa98d	6
1151101	water 983 MG/ML Ophthalmic Irrigation Solution	SCD	777e1559-786f-8d54-e053-2991aa0aa98d	6
1424605	Pur-Wash 98.3 % Ophthalmic Irrigation Solution	SY	777e1559-786f-8d54-e053-2991aa0aa98d	6
1424605	Pur-Wash 983 MG/ML Ophthalmic Irrigation Solution	SY	777e1559-786f-8d54-e053-2991aa0aa98d	6
1151101	water 98.3 % Ophthalmic Irrigation Solution	SY	777e1559-786f-8d54-e053-2991aa0aa98d	6
1151101	water 98.3 % Ophthalmic Irrigation Solution	PSN	d3812fa3-9334-464d-b50c-98548ff76727	4
1151101	water 983 MG/ML Ophthalmic Irrigation Solution	SCD	d3812fa3-9334-464d-b50c-98548ff76727	4
1151101	water 98.3 % Ophthalmic Irrigation Solution	SY	d3812fa3-9334-464d-b50c-98548ff76727	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65785-162-01	65785016201	236 mL in 1 BOTTLE, UNIT-DOSE (65785-162-01)	236 ml	2011-09-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pur-Wash Purified Water, 98.3% Ophthalmic Solution Eyewash	Niagara Pharmaceuticals Inc. \| STERIS Applied Sterilization Technologies ULC \| Isomedix Operations Inc.	2025-11-24	HUMAN OTC DRUG LABEL	6
PhysiciansCare Ophthalmic Solution Eyewash	Acme United Corporation \| Acme United Corporation Vancouver Division	2024-11-26	HUMAN OTC DRUG LABEL	4