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ULINE Eyewash

Eyewash · Solution

Over-the-counter NDA RLD Official labelling

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name

ULINE Eyewash

Generic name

Eyewash

Dosage form

Solution

Route

Ophthalmic

Marketing category

NDA · NDA

Labeler

Niagara Pharmaceuticals Inc.

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Water	465 mL/473mL	1053154	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Solution

Route of administration

Ophthalmic

Presentations

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

022305

Application type

NDA · New Drug Application

Approval date

September 1, 2011

Sponsor

NIAGARA PHARMS

Products on application

Submissions recorded

Products approved under application 022305.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
022305-001	PUR-WASH	SOLUTION		PURIFIED WATER	Over-the-counter	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 022305.
Type	No.	Action	Status	Date	Review
Supplement	8	Labeling	Approved	February 2, 2026	Standard
Supplement	7	Labeling	Approved	June 26, 2025	Standard
Supplement	6	Labeling	Approved	December 12, 2019	Standard
Supplement	4	Manufacturing (CMC)	Approved	January 7, 2015	Standard
Supplement	1	Manufacturing (CMC)	Approved	September 26, 2013	Standard
Original application	1	Type 5 - New Formulation or New Manufacturer	Approved	September 1, 2011	Standard

Review documents

0 · Supplement · February 5, 2026
0 · Supplement · June 27, 2025
0 · Original application · June 26, 2012
0 · Original application · June 26, 2012
0 · Original application · September 16, 2011

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251124). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251124

Indications and Usage

openFDA Drug Labeling

Use For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Purpose

openFDA Drug Labeling

Purpose Eyewash

Dosage and Administration

openFDA Drug Labeling

Dosage & Administration Remove Tamper evident seal and cap flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

Warnings

openFDA Drug Labeling

Warnings For external use only Do not use if you experience any open wounds in or near the eyes and obtain immediate medical treatment if solution changes color or becomes cloudy When using this product to avoid contamination, do not touch tip of container to any surface do not reuse once opened, discard

Ask a Doctor

openFDA Drug Labeling

Stop use and ask a doctor if you have any of the following continued redness or irritation of the eye condition worsens or persists eye pain changes in vision

Active Ingredient

openFDA Drug Labeling

Active ingredient Purified water 98.3%

Adverse event reports

Source: openFDA FAERS

19,134

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: WATER. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
65785-125-01	65785-125	Niagara Pharmaceuticals Inc.	473 mL in 1 BOTTLE, UNIT-DOSE (65785-125-01)	April 1, 2024
65785-125-02	65785-125	Niagara Pharmaceuticals Inc.	946 mL in 1 BOTTLE, UNIT-DOSE (65785-125-02)	April 1, 2024
69790-010-16	69790-010	Uline.	473 mL in 1 BOTTLE, UNIT-DOSE (69790-010-16)	April 1, 2024
69790-010-32	69790-010	Uline.	946 mL in 1 BOTTLE, UNIT-DOSE (69790-010-32)	April 1, 2024
65785-125	65785-125	Niagara Pharmaceuticals Inc.	—	April 1, 2024
69790-010	69790-010	Uline.	—	April 1, 2024

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.