PUR-WASH Water 929 g/946mL Solution, 473 mL
by Niagara Pharmaceuticals Inc. · 473 mL in 1 BOTTLE, UNIT-DOSE (65785-166-01)
NDC 65785-0166-01
🏷️ FDA NDC (as labeled)
65785-166-01
billing pads the product segment with a zero
This package
Contains473 mL
Pack sizes2 compare ↓
Also comes in:
946 ml 65785-0166-02
OTC
Brand
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Water (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 2, 2026 — Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. (B BRAUN MEDICAL INC) · FDA recall D-0495-2026
Class II · Dec 22, 2025 — Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution (Baxter Healthcare Corporation) · FDA recall D-0296-2026
Class II · Aug 26, 2025 — Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. (B BRAUN MEDICAL INC) · FDA recall D-0652-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
65785-166-01
Product NDC
65785-166
11-digit billing NDC
65785016601
UNII
059QF0KO0R
Application #
NDA022305
SPL Set ID
7289103a-5cbf-42f4-8848-e827149a43ca
DEA schedule
Non-controlled
Marketing category
NDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2013-05-24
Route
OPHTHALMIC
Dosage form
SOLUTION
Substance
WATER
Why two NDCs?
The FDA registers this code as 65785-166-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 65785-0166-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏭 Manufacturer & labeler
LabelerNiagara Pharmaceuticals Inc.
Application holderNIAGARA PHARMACEUTICALS INC
FDA applicationNDA022305 (NDA)
Labeler code65785
First marketedMay 2013
Product typeHuman Otc Drug
Portfolio6 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
📗 Our plain-language guide HelloPharmacist
- It can seem a little odd at first. In these products, sterile water plays the essential role of carrying or dissolving the actual active medication — like insulin — so it can be sa...
- Why is 'water' listed as the active ingredient on my medicine?
- No — these are very different products that should never be used interchangeably. Sterile Water for Injection is used only as a diluent for other drugs given by needle, and it must...
- Is Sterile Water for Injection the same as the eye wash or the irrigation product?
Patient education
Supplement & herbal interactions
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about Water?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size:
946 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3% 465 mL/473mL 00924-0158-16 | Acme | 473 ml | — | — | FDA listed | — |
| PhysiciansCare Ophthalmic Solution Eyewash 929 g/946mL 00924-0160-01 | Acme | 30 ml | — | — | FDA listed | — |
| PhysiciansCare Ophthalmic Solution Eyewash 929 g/946mL 00924-0162-08 | Acme | 236 ml | — | — | FDA listed | — |
| Physicians Care Eyewash 465 mL/473mL 00924-0163-01 | Acme | 29 ml | — | — | FDA listed | — |
| Easy Care First Aid Eyewash 929 g/946mL 44224-0160-01 | Tender | 30 ml | — | — | FDA listed | — |
| Medi-First First Aid Eye Wash 983 mg/mL 47682-0197-11 | Unifirst | 473 ml | — | — | FDA listed | — |
| Medi-First First Aid Eye Wash 983 mg/mL 47682-0198-08 | Unifirst | 236 ml | — | — | FDA listed | — |
| Green Guard First Aid Eye Wash .983 mg/mL 47682-0410-08 | Unifirst | 236 ml | — | — | FDA listed | — |
| Green Guard First Aid Eye Wash .983 mg/mL 47682-0412-11 | Unifirst | 473 ml | — | — | FDA listed | — |
| Medi-First Plus First Aid Eye Wash .983 mg/mL 47682-0936-18 | Unifirst | 118 ml | — | — | FDA listed | — |
| Eye Clean 98.3 mL/100mL 50332-0201-01 | HART | 118 ml | — | — | FDA listed | — |
| AeroWash Eyewash .983 mL/mL 55305-0115-10 | Aero | 30 ml | — | — | FDA listed | — |
| ULINE Eyewash 465 mL/473mL 65785-0125-01 | Niagara | 473 ml | — | — | FDA listed | — |
| Pur-Wash 929 g/946mL 65785-0160-01 | Niagara | 30 ml | — | — | FDA listed | — |
| Pur-Wash 929 g/946mL 65785-0162-01 | Niagara | 236 ml | — | — | Discontinued | — |
| Pur-Wash 929 g/946mLthis 65785-0166-01 | Niagara | 473 ml | — | — | FDA listed | — |
| Pur-Wash 465 mL/473mL 65785-0168-01 | Niagara | 473 ml | — | — | FDA listed | — |
| Pur-Wash 929 g/946mL 65785-0169-01 | Niagara | 30 ml | — | — | FDA listed | — |
| Eye wash 98.3 mL/100mL 68599-1981-01 | McKesson | 29.6 ml | — | — | FDA listed | — |
| ULINE Eyewash 465 mL/473mL 69790-0010-16 | Uline. | 473 ml | — | — | FDA listed | — |
| Firstep Firstflush 465 mL/473mL 70290-0310-32 | Encon | 946 ml | — | — | FDA listed | — |
| ECOLAB Eye Wash .983 mg/mL 71338-0119-18 | ECOLAB | 118 ml | — | — | FDA listed | — |
| Dynamic Eyewash with Eyecup 929 g/946mL 72745-0101-16 | Dynamic | 473 ml | — | — | FDA listed | — |
| Kollourion Eyesalve Eyewash 929 g/946mL 72924-0001-01 | Miracle | 1 bottle | — | — | FDA listed | — |
| Thompson Safety Eyewash 929 g/946mL 73408-0198-18 | Thompson | 118 ml | — | — | FDA listed | — |
| Crane Safety Eye Wash .983 mg/mL 73408-0936-18 | Crane | 118 ml | — | — | FDA listed | — |
| Eyewash 465 mL/473mL 78641-0786-67 | Global | 473 ml | — | — | FDA listed | — |
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2013
On the market since
May 2013
📍
2026
Currently FDA-listed
13 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PUR-WASH (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 38%
Female · 62%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 65785-0166-01 You're viewing this | 473 mL in 1 BOTTLE, UNIT-DOSE (65785-166-01) | 2013-05-24 | Active |
| 65785-0166-02 | 946 mL in 1 BOTTLE, UNIT-DOSE (65785-166-02) | 2013-05-24 | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 65785-0166-01?
NDC 65785-0166-01 contains 473 mL — 473 ml in 1 bottle, unit-dose.
What is the difference between NDC 65785-0166-01 and NDC 65785-0166-02?
Both are PUR-WASH Water 929 g/946mL Solution — the drug itself is identical. NDC 65785-0166-01 is the 473 mL package, while NDC 65785-0166-02 is the 946 ml package.
What NDC number is used to bill for this package of PUR-WASH Water 929 g/946mL Solution?
Bill NDC 65785-0166-01 — the 11-digit billing format is 65785016601. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | — Not published for this NDC No photo available yet for this listing. |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 65785-166-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 65785-0166-01, written without dashes as 65785016601. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 65785-0166-01, the first segment (65785) is the labeler code FDA assigned to Niagara Pharmaceuticals Inc.; the middle segment (0166) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Niagara Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 946 ml (65785-0166-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Niagara Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Use For cleansing the eye to help relieve irritation or burning by removing loose foreign material
⏱️ Dosage and Administration ▾
Directions • pull cover off cap • avoid contamination of rim and inside surfaces of the eyecup • place eyecup surface to the affected eye, pressing tightly to prevent the escape of the liquid and tilt the head backward • open eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash
⚠️ Warnings ▾
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 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
🧪 Active Ingredient ▾
Active ingredient Purified water 98.3%
🧪 Inactive Ingredients ▾
Inactive ingredients boric acid, sodium borate, sodium chloride
🎯 Purpose ▾
Purpose Eyewash
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.