Application 022305

Type: NDA
Sponsor: NIAGARA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PUR-WASH	PURIFIED WATER	SOLUTION;OPHTHALMIC	98.3%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2022-10-28 04:53 UTC	2022-10	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022305-001	PUR-WASH	98.3%	SOLUTION / OPHTHALMIC	RLD, RS	2011-09-01	`cb3db0bc1861…`

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 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Firstep Firstflush	EYEWASH	Encon Safety Products, Inc.	a44beb26-79ae-98bd-e053-2995a90a9b74	2025-12-09	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 70290-310
PUR-WASH	WATER	Niagara Pharmaceuticals Inc.	beda35c3-9a8b-47ad-e053-2995a90a7b1b	2025-11-24	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 65785-169
Easy Care First Aid Eyewash	WATER	Tender Corporation	a070aac8-e6d2-ef10-e053-2a95a90aa5b1	2025-11-24	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 44224-0160
PUR-WASH	WATER	Niagara Pharmaceuticals Inc.	e07a064b-f680-405c-bbcd-24fac430951e	2025-11-24	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 65785-160
ULINE Eyewash	EYEWASH	Niagara Pharmaceuticals Inc.	2d7f22d2-320b-6af1-e063-6294a90addc6	2025-11-24	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305
Pur-Wash	EYEWASH	Niagara Pharmaceuticals, Inc.	0d43b1c1-2699-37f1-e054-00144ff88e88	2025-11-24	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 65785-168
PUR-WASH	WATER	Niagara Pharmaceuticals Inc.	777e1559-786f-8d54-e053-2991aa0aa98d	2025-11-24	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 65785-162
PUR-WASH	WATER	Niagara Pharmaceuticals Inc.	7289103a-5cbf-42f4-8848-e827149a43ca	2025-11-24	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 65785-166
Medi-First First Aid Eye Wash	PURIFIED WATER	Unifirst First Aid Corporation	dcd7fe56-ff5c-4c8d-a415-6e363d7e53f4	2025-09-08	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 47682-198 ndc (product): 47682-197
Green Guard First Aid Eye Wash	WATER	Unifirst First Aid Corporation	a4ba5526-b4e2-4bcc-9127-aa22ebf5017f	2025-09-08	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 47682-410 ndc (product): 47682-412
Medi-First Plus First Aid Eye Wash	WATER	Unifirst First Aid Corporation	d7ea80ca-b4a0-4476-8b50-b3425c6d456a	2025-09-08	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 47682-936
ECOLAB Eye Wash	PURIFIED WATER	ECOLAB Food Safety Specialties, Inc.	4bcfa21a-791e-4d04-e054-00144ff88e88	2025-09-08	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 71338-119
AeroWash Eyewash	EYEWASH SOLUTION	Aero Healthcare US LLC	a477de08-4301-0ee5-e053-2995a90af79d	2025-02-26	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 55305-115
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%	PURIFIED WATER 98.3%	Acme United Corporation	9248ee71-2d47-620d-e053-2995a90af5c8	2024-11-26	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 0924-0158
PhysiciansCare Ophthalmic Solution Eyewash	PURIFIED WATER 98.3%	Acme United Corporation	cca454e0-b2bd-4215-bc06-426fcc3f7bd6	2024-11-26	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 0924-0160
PhysiciansCare Ophthalmic Solution Eyewash	PURIFIED WATER 98.3%	Acme United Corporation	d3812fa3-9334-464d-b50c-98548ff76727	2024-11-26	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 0924-0162
Crane Safety Eye Wash	WATER SOLUTION	Crane Safety LLC	96d8dda9-6cd6-3f68-e053-2995a90a0da2	2024-11-08	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 73408-936
Thompson Safety Eyewash	WATER	Thompson Safety	1d0e96cf-245b-cfb7-e063-6294a90a4ced	2024-07-12	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305
ULINE Eyewash	EYEWASH	Uline.	14545fc9-1fb4-befa-e063-6294a90a0474	2024-03-23	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305
Eye wash	PURIFIED WATER	McKesson	bd089fde-24ba-4de5-e053-2995a90a39bb	2022-10-18	Warnings	Exact identifier application applno (NDA): 022305 application number: NDA022305 ndc (product): 68599-1981

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 61 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-7198	Eyewash	Water	Henry Schein, Inc.	NDA	Current
0404-7198	Eyewash	Water	Henry Schein, Inc.	NDA	Current
0404-7198	Eyewash	Water	Henry Schein, Inc.	NDA	Current
0924-0158	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
0924-0158	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
0924-0160	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
0924-0160	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
0924-0162	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
0924-0162	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
0924-0168	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
0924-0168	PhysiciansCare Ophthalmic Solution Eyewash	Purified Water 98.3%	Acme United Corporation	NDA	Current
13985-609	Eyewash	Water	MWI	NDA	Current
13985-609	Eyewash	Water	MWI	NDA	Current
13985-609	Eyewash	Water	MWI	NDA	Current
17478-620	Eyewash	Water	Akorn	NDA	Current
17478-620	Eyewash	Water	Akorn	NDA	Current
17478-620	Eyewash	Water	Akorn, Inc.	NDA	Current
17478-620	Eyewash	Water	Akorn, Inc.	NDA	Current
44224-0160	Easy Care First Aid Eyewash	Water	Tender Corporation	NDA	Current
47682-197	Medi-First First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-197	Medi-First First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-197	Medi-First First Aid Eye Wash	Purified Water	Unifirst First Aid Corporation	NDA	Current
47682-198	Medi-First First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-198	Medi-First First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-198	Medi-First First Aid Eye Wash	Purified Water	Unifirst First Aid Corporation	NDA	Current
47682-410	Green Guard First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-410	Green Guard First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-410	Green Guard First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-412	Green Guard First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-412	Green Guard First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-412	Green Guard First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-936	Medi-First Plus First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-936	Medi-First Plus First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
47682-936	Medi-First Plus First Aid Eye Wash	Water	Unifirst First Aid Corporation	NDA	Current
55305-115	AeroWash Eyewash	Eyewash Solution	Aero Healthcare US LLC	NDA	Current
59276-416	Real Eyewash	Eyewash	Oliver Landon Intl Inc.	NDA	Current
65785-160	PUR-WASH	Water	Niagara Pharmaceuticals Inc.	NDA	Current
65785-162	PUR-WASH	Water	Niagara Pharmaceuticals Inc.	NDA	Current
65785-164	PUR-WASH	Water	Niagara Pharmaceuticals Inc.	NDA	Current
65785-166	PUR-WASH	Water	Niagara Pharmaceuticals Inc.	NDA	Current
65785-168	Pur-Wash	Eyewash	Niagara Pharmaceuticals, Inc.	NDA	Current
65785-168	Pur-Wash	Eyewash	Niagara Pharmaceuticals, Inc.	NDA	Current
65785-169	PUR-WASH	Water	Niagara Pharmaceuticals Inc.	NDA	Current
68071-2234	EyeWash	EyeWash	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-2234	EyeWash	EyeWash	NuCare Pharmaceuticals,Inc.	NDA	Current
68599-1981	Eye wash	Purified Water	McKesson	NDA	Current
68599-1981	Eye wash	Purified Water	McKesson	NDA	Current
70290-310	Firstep Firstflush	Eyewash	Encon Safety Products, Inc.	NDA	Current
70290-310	Firstep Firstflush	Eyewash	Encon Safety Products, Inc.	NDA	Current
71338-119	ECOLAB Eye Wash	Purified Water	ECOLAB Food Safety Specialties, Inc.	NDA	Current
71338-119	ECOLAB Eye Wash	Purified Water	ECOLAB Food Safety Specialties, Inc.	NDA	Current
71338-119	ECOLAB Eye Wash	Purified Water	ECOLAB Food Safety Specialties, Inc.	NDA	Current
72745-100	Dynamic Eyewash	Water	Dynamic Safety International	NDA	Current
72745-101	Dynamic Eyewash with Eyecup	Water	Dynamic Safety International	NDA	Current
73408-936	Crane Safety Eye Wash	water solution	Crane Safety LLC	NDA	Current
73408-936	Crane Safety Eye Wash	water solution	Crane Safety LLC	NDA	Current
73408-936	Crane Safety Eye Wash	water solution	Crane Safety LLC	NDA	Current
78641-786	Eyewash	Eyewash	Global Equipment Company	NDA	Current
81238-6708	Neutral-Eyes	Purified Water 98.3%	Western First Aid Safety	NDA	Current
81238-6708	Neutral-Eyes	Purified Water 98.3%	Western First Aid Safety	NDA	Current
81238-6708	Neutral-Eyes	Purified Water 98.3%	Western First Aid Safety	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84916	SUPPL	2026-02-05
82675	SUPPL	2025-06-27
44731	ORIG	2012-06-26
42482	ORIG	2012-06-26
29558	ORIG	2011-09-16