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Ecolab Inc. Benzalkonium chloride 8.9 mg/mL Solution, 2000 mL — NDC 47593-0512-61 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ecolab Inc. Benzalkonium chloride 8.9 mg/mL Solution, 2000 mL — NDC 47593-512-61 (Billing 47593-0512-61)

by Ecolab Inc. · 2000 mL in 1 POUCH

This is a package of 2,000 mL of Ecolab Inc. Benzalkonium chloride 8.9 mg/mL Solution from Ecolab Inc., marketed since Mar 2015 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 47593-0512-61
🏷️ FDA NDC (as labeled) 47593-512-61 billing pads the product segment with a zero
This package
Contains2000 mL Pack sizes3 compare ↓
Main listing for product 47593-512 · Also comes in: 1300 ml 47593-512-62 1900 ml 47593-512-94
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 47593-512-61 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
47593 labeler · 512 product · 61 package
Package marketed since
Mar 2, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4759351261 0
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Benzalkonium Chloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 8, 2026 — CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0693-2026
Class II · Apr 8, 2026 — CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0699-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0375-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0369-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0365-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0374-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 47593-512-61
Product NDC 47593-512
11-digit billing NDC 47593051261
RxCUI 1604323
UNII F5UM2KM3W7
Application # 505G(a)(3)
SPL Set ID 7873638a-afd7-4b55-bcc5-0e893a437fb3
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-03-02
Route TOPICAL
Dosage form SOLUTION
Substance BENZALKONIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1604323
Why two NDCs? The FDA registers this code as 47593-512-61 — 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 → 47593-0512-61. 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.

RxNorm drug class

This medicine belongs to the Quaternary ammonium compounds class.

Drug family (ATC) Quaternary ammonium compounds, Medicated dressings with antiinfectives, Antiseptics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

🧪 What is this product?

This is a topical solution containing benzalkonium chloride, an antimicrobial agent commonly used in over-the-counter products for skin cleansing and disinfection. The product is marketed as an OTC monograph drug, meaning it is formulated according to established FDA guidelines for this category rather than as an individually approved application. Benzalkonium chloride functions as a broad-spectrum antimicrobial and is typically found in hand sanitizers, first-aid antiseptics, and wound-care preparations.

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.
Try another pack size: 1300 ml 1900 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
47593-0512-61 You're viewing this Main listing 2000 mL in 1 POUCH 2015-03-02 — Active
47593-0512-62 47593-512-62 1300 mL in 1 BOTTLE, PLASTIC 2015-03-02 — Active
47593-0512-94 47593-512-94 1900 mL in 1 BOTTLE, PLASTIC 2024-05-03 — Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 2000 mL — 2000 ml in 1 pouch.
How does this package differ from NDC 47593-0512-62?
Both are Ecolab Inc. Benzalkonium chloride 8.9 mg/mL Solution — the drug itself is identical. This page's package is the 2000 mL one, while NDC 47593-0512-62 is the 1300 ml package.
What NDC number is used to bill for this package of Ecolab Inc. Benzalkonium chloride 8.9 mg/mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ecolab Inc. 8.9 mg/mLthis 47593-0512-61 Ecolab 2000 ml — — FDA listed —
Ecolab Concentrated Foaming Antibacterial Handsoap 8.9 mg/mL 47593-0676-61 Ecolab 2000 ml — — FDA listed —
Ecolab Inc. 8.9 mg/mL 47593-0514-62 Ecolab 1300 ml — — FDA listed —
Ecolab Inc. 8.9 mg/mL 47593-0513-62 Ecolab 1300 ml — — FDA listed —
Ecolab Inc. 8.9 mg/mL 47593-0511-61 Ecolab 2000 ml — — 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

🏛️
2015
On the market since
Mar 2015
📍
2026
Currently FDA-listed
11 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.

  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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.

5 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesInactive ingredients  water (aqua), propylene glycol, sodium benzoate, FD&C yellow 5, FD&C red 40

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

LabelerEcolab Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code47593
First marketedMar 2015
Product typeHuman Otc Drug
Portfolio115 products on file

More NDCs from Ecolab Inc. labeler code 47593

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 🧪 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 📚 References 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 9 words ▾

Uses For handwashing to decrease bacteria on the skin

⏱️ Dosage and Administration 20 words ▾

Directions: Ready-To-Use Solution wash hands to remove soil apply sanitizer to hands spread to cover hands thoroughly, rub to dry

⚠️ Warnings 66 words ▾

Warnings For external use only Do not use In eyes When using this product If in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Posoin Control Center right away.

🧪 Active Ingredient 5 words ▾

Active ingredient Benzalkonium chloride 0.89%

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients water (aqua), propylene glycol, sodium benzoate, FD&C yellow 5, FD&C red 40

🎯 Purpose 3 words ▾

Purpose Antispetic handwash

📄 Do Not Use 5 words ▾

Do not use In eyes

📄 Ask a Doctor Before Use If 17 words ▾

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours

📄 When Using This Product 20 words ▾

When using this product If in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Questions or Comments 4 words ▾

Questions? call 1-800-35-CLEAN (352-5326)

📚 References 36 words ▾

Other information for additional information, see Safety Data Sheet (SDS) EMERGENCY HEALTH INFORMATION: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).

📖 Instructions for Use 52 words ▾

Directions: Concentrated Solution do not mix with anything except for potable water use only provided bottles for dilution and dispensing of ready-to-use product remove cap, open dispenser door, place bottle into position, and close dispenser door fill hand sanitizer bottle with solution form dispenser place bottle into a Nexa dispenser for use

📄 Package Label / Principal Display Panel 55 words ▾

Principal display panel and representative label ECOLAB® 6100873 Concentrated Foam1.3 L (44 US FL OZ) Active ingredient: Benzalkonium chloride, 0.89% Ecolab - 1 Ecolab Place - St. Paul MN 55102 USA tel: 1 800 35 CLEAN (352 5326) © 2018 Ecolab USA Inc • All rights reserved Made in U.S.A. www.ecolab.com • 759250/5401/1018 representative label

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

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 Ecolab Inc. (this brand).

Top reported reactions

Drug Hypersensitivity118
Condition Aggravated114
Arthralgia112
Musculoskeletal Stiffness111
Pain In Extremity111
Infection110
Hepatotoxicity108

Reporter sex

331 reports
Male · 28%
Female · 72%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 77 5
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.

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 Ecolab 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 2 other package presentations of this same product, including 1300 ml (47593-0512-62), 1900 ml (47593-0512-94). 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?
Ecolab 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.
← 47593-0511-61 · Ecolab 47593-0513-62 · Ecolab →
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.