Home › NDC Lookup › Ingredients › Chlorhexidine Gluconate And Propylene Gl... › 65785-0034-01
Eyewash Station Additive Concentrate Chlorhexidine gluconate and Propylene Glycol 145.6 kg/2800L; 280 kg/2800L Liquid, 236 l — NDC 65785-0034-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Eyewash Station Additive Concentrate Chlorhexidine gluconate and Propylene Glycol 145.6 kg/2800L; 280 kg/2800L Liquid, 236 l — NDC 65785-034-01 (Billing 65785-0034-01)

by Niagara Pharmaceuticals Inc. · .236 L in 1 BOTTLE, UNIT-DOSE

This is a package of 236 l of Eyewash Station Additive Concentrate Chlorhexidine gluconate and Propylene Glycol 145.6 kg/2800L; 280 kg/2800L Liquid from Niagara Pharmaceuticals Inc., marketed since Nov 2011 and currently FDA-listed. It is this product's only package size.

NDC 65785-0034-01
🏷️ FDA NDC (as labeled) 65785-034-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 65785-034-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
65785 labeler · 034 product · 01 package
Package marketed since
Nov 15, 2011
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6578503401 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 65785-034-01
Product NDC 65785-034
11-digit billing NDC 65785003401
UNII MOR84MUD8E, 6DC9Q167V3
Application # M018
SPL Set ID 362a6b6d-862d-4322-87a8-5b3a07fbe174
Physiologic effect Decreased Cell Wall Integrity
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-11-15
Route OPHTHALMIC
Dosage form LIQUID
Substance CHLORHEXIDINE GLUCONATE; PROPYLENE GLYCOL
Why two NDCs? The FDA registers this code as 65785-034-01 — 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 → 65785-0034-01. 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.

Clinical

🧪 What is this product?

This is an over-the-counter eyewash station additive concentrate for ophthalmic use, marketed under FDA's OTC monograph rules. It contains chlorhexidine gluconate, an antimicrobial agent typically used to reduce bacteria and other microorganisms, and propylene glycol, a humectant that is commonly used to help lubricate and preserve liquid eye products. The concentrate is diluted to prepare eyewash solution for emergency eye-rinsing stations.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 systemPer mLPer 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.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
65785-0034-01 You're viewing this Main listing .236 L in 1 BOTTLE, UNIT-DOSE 2011-11-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Eyewash Station Additive Concentrate 145.6 kg/2800L; 280 kg/2800Lthis 65785-0034-01 Niagara 236 l — — FDA listed —
Eyewash Station Additive Concentrate 145.6 kg/2800L; 280 kg/2800L 00924-0159-08 Acme 236 l — — FDA listed —
Eyewash Station Additive Concentrate 145.6 kg/2800L; 280 kg/2800L 78641-0785-63 Global 236 l — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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

🏛️
2011
On the market since
Nov 2011
📍
2026
Currently FDA-listed
15 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.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 2374.4 L / 2800 L UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesChlorhexidine gluconate 1% w/v Purified Water, Propylene Glycol

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

Manufacturer & labeler

LabelerNiagara Pharmaceuticals Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code65785
First marketedNov 2011
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from Niagara Pharmaceuticals Inc. labeler code 65785

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.

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

Use A preservative for use in potable self-contained emergency eyewash stations

⏱️ Dosage and Administration 81 words ▾

Directions wear protective eyewear and gloves clean potable eyewash station and rinse with potable water partially fill station with potable water remove tamper evident seal and cap of bottle add entire contents of the bottle to the eyewash station container fill the station to the manufacturer's required level date and initial inspection tag station should be cleaned and refilled every 120 days when using this product in advance of emergency, add the concentrate to potable water to have a solution available

⚠️ Warnings 88 words ▾

Warnings For external use only. In case of contact with eye in undiluted form, flush with clean water Do not use in full strength When using this product do not change dilution or use with other chemicals do not reuse Stop use and ask a doctor if you have any of the following changes in vision eye pain condition worsens or persists continued redness or irritation of the eye Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 52 words ▾

Other information lot number is printed on the bottle store at 20° to 25° C [68° to 77° F] for your protection, this bottle has an imprinted white seal with black printing "TAMPER EVIDENT SEAL" do not use if this seal is missing or broken use before expiration date marked on bottle

🧪 Active Ingredient 9 words ▾

Ingredients Chlorhexidine gluconate 1% w/v Purified Water, Propylene Glycol

🧪 Inactive Ingredients 8 words ▾

Chlorhexidine gluconate 1% w/v Purified Water, Propylene Glycol

🎯 Purpose 2 words ▾

Purpose Preservative

📄 Do Not Use 6 words ▾

Do not use in full strength

📄 Ask a Doctor Before Use If 29 words ▾

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

📄 When Using This Product 16 words ▾

When using this product do not change dilution or use with other chemicals do not reuse

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 13 words ▾

Questions ? ☎ Call 905 690-6277 9 a.m. to 5 p.m. EST Mon-Fri

📄 Package Label / Principal Display Panel 70 words ▾

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label EYEWASH STATION ADDITIVE CONCENTRATE NDC 65785-034-01 A preservative for potable water. Preserves from 5 - 20 US Gallons (15 - 76 Liters) FOR USE IN EMERGENCY EYEWASH STATIONS. Manufactured by: Niagara Pharmaceuticals Inc. 60 Innovation Dr. Flamborough ON L9H 7P3 Made in Canada 8 Fl Oz [236 mL] HEALTH SAVER ® The Safe Solution™ PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 ✓ Available
Inactive ingredients (structured) ✓ 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
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.
← 65757-0728-03 · Alkermes, 65785-0125-01 · Niagara →
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.