Home › NDC Lookup › Ingredients › Benzalkonium Chloride › 47593-0676-61
Ecolab Concentrated Foaming Antibacterial Handsoap Benzalkonium chloride 8.9 mg/mL Solution, 2000 mL — NDC 47593-0676-61 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ecolab Concentrated Foaming Antibacterial Handsoap Benzalkonium chloride 8.9 mg/mL Solution, 2000 mL — NDC 47593-676-61 (Billing 47593-0676-61)

by Ecolab Inc. · 2000 mL in 1 BOTTLE, PLASTIC

This is a package of 2,000 mL of Ecolab Concentrated Foaming Antibacterial Handsoap Benzalkonium chloride 8.9 mg/mL Solution from Ecolab Inc., marketed since Dec 2025 and currently FDA-listed. It is this product's only package size.

NDC 47593-0676-61
🏷️ FDA NDC (as labeled) 47593-676-61 billing pads the product segment with a zero
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 47593-676-61 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
47593 labeler · 676 product · 61 package
Package marketed since
Dec 17, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4759367661 9
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) 47593-676-61
Product NDC 47593-676
11-digit billing NDC 47593067661
RxCUI 1603470
UNII F5UM2KM3W7
Application # 505G(a)(3)
SPL Set ID 5427ae5c-83d1-4395-8155-6837cc22a95f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-17
Route TOPICAL
Dosage form SOLUTION
Substance BENZALKONIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1603470
Why two NDCs? The FDA registers this code as 47593-676-61 — 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 → 47593-0676-61. 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 foaming hand soap solution for topical use containing benzalkonium chloride, an antimicrobial agent. Benzalkonium chloride is commonly used in over-the-counter hand soaps and cleansers to help reduce bacteria on the skin. This product is marketed as an OTC monograph drug, meaning it follows FDA's established safety and use guidelines for antibacterial hand soaps rather than undergoing individual drug approval review.

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
47593-0676-61 You're viewing this Main listing 2000 mL in 1 BOTTLE, PLASTIC 2025-12-17 — Active

Therapeutic equivalents

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

🏛️
2025
On the market since
Dec 2025
📍
2026
Currently FDA-listed
1 year 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 H2KVQ74JM4
    A compound derived from coconut oil that acts as a conditioning agent and surfactant. It helps stabilize and thicken liquid formulations while reducing static and improving texture in topical products.
  • UNII 9DBA0SBB0L
    A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII IWS58C6V2Y
    A synthetic emollient and emulsifier derived from glycerin and fatty acids. It helps blend oil and water components in formulations and provides a smooth texture to creams, lotions, and other topical products.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII 4F6FC4MI8W
    Lauramine oxide is a surfactant, a substance that helps mix oil and water together. It's used in medicines to improve how ingredients blend and to help the product dissolve or spread properly.
  • UNII J3QD0LD11P
    A synthetic compound made by combining glucose with methyl alcohol and polyethylene glycol. It acts as an emulsifier and solvent to help blend water and oil-based ingredients and improve how the medicine dissolves or spreads.
  • UNII DEL7T5QRPN
    A synthetic preservative that kills bacteria and fungi. It's added to medications to prevent microbial growth and extend shelf life, especially in liquid or topical formulations.
  • UNII ZEL54N6W95
    A silicone-based compound that helps oils and water mix together. Used in medicines as an emulsifier and anti-foaming agent to improve texture and prevent bubbles in liquids and creams.
  • UNII VNX7251543
    A plant-derived emulsifier made from coconut oil and polyethylene glycol. It helps mix oil and water-based ingredients together and improves how the medicine spreads or absorbs.
  • UNII 0L414VCS5Y
    A synthetic polymer used as a film-former and conditioning agent. It helps create a protective coating on hair or skin surfaces and improves texture and manageability in topical formulations.
  • 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.

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

The official label also statesIngredients (acc. INCI): water (aqua), lauryl dimethylamine oxide, cocoamidopropyl PG-dimonium chloride phosphate, glycerine, polyquaternium-77, hexylene glycol, methyl gluceth-20, PEG-7 glyceryl cocoate, tetrasodium EDTA, polyquaternium-7, lactic acid, chloro-2-methyl-4-isothiazolin-3-one, PEG-12 dimethicone. glycereth-18 ethylhexanoate, fragrance, D&C Red 33

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 marketedDec 2025
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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 9 words ▾

Uses for handwashing to decrease bacteria on the skin

⏱️ Dosage and Administration 88 words ▾

Directions: Concentrated Solution do not mix with anything except for potable water use only provided bottles for diution and dispensing of ready-to-use product insert probe into bag, twist cap tight, and close dispenser fill hand soap bottle with solution from dispenser place bottle into a Nexa dispenser for use Directions: Ready-To-Use Solution wet hands with warm water apply soap to hands and scrub vigorously wash between fingers, around fingernails, and back of hands rinse hands thoroughly with warm water dry hands with clean towel or with mechanical dryer

⚠️ 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 Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active ingredient Benzalkonium chloride 1.89%

🧪 Inactive Ingredients 35 words ▾

Ingredients (acc. INCI): water (aqua), lauryl dimethylamine oxide, cocoamidopropyl PG-dimonium chloride phosphate, glycerine, polyquaternium-77, hexylene glycol, methyl gluceth-20, PEG-7 glyceryl cocoate, tetrasodium EDTA, polyquaternium-7, lactic acid, chloro-2-methyl-4-isothiazolin-3-one, PEG-12 dimethicone. glycereth-18 ethylhexanoate, fragrance, D&C Red 33

🎯 Purpose 3 words ▾

Purpose Antiseptic 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 Poison Control Center right away.

📄 Questions or Comments 3 words ▾

Questions? call 1-800-529-5458

📚 References 20 words ▾

Other information for additional information, see Safety Data Sheet (SDS) Medical Emergency: (877) 231-2615 or call collect 0 (952) 853-1713

📄 Package Label / Principal Display Panel 68 words ▾

Principal Display Panel and Representative Label ECOLAB ® Concentrated Foaming Antibacterial Hand Soap FOR INSTITUTIONAL USE ONLY Distributed by | Distribuido por: Kay Chemical Company · 8300 Capital Drive Greensboro NC 27409-9790 USA Customer Service: (800) 529-5458 ©2016 Kay Chemical Company All rights reserved | Todas los derechos reservados Made in USA | Hecho en Estados Unidos 763845-00 KUSA 7+3845/8000/0116 Net contents: 2L (0.53 US Gal) 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 Concentrated Foaming Antibacterial Handsoap (this brand).

Top reported reactions

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

Reporter sex

331 reports

Serious outcomes

Death25
Disabling18
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 77 0
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.
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.
← 47593-0675-11 · Ecolab 47593-0677-59 · 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.