HomeNDC LookupIngredientsBenzalkonium Chloride › 47593-0681-59
MYSTIC FOAMING ANTI-BACTERIAL HANDSOAP Benzalkonium Chloride 5 mg/mL Solution, 1250 mL — NDC 47593-0681-59 package photo

MYSTIC FOAMING ANTI-BACTERIAL HANDSOAP Benzalkonium Chloride 5 mg/mL Solution, 1250 mL

by Ecolab Inc. · 1250 mL in 1 BOTTLE, PLASTIC (47593-681-59)
NDC 47593-0681-59
🏷️ FDA NDC (as labeled) 47593-681-59 billing pads the product segment with a zero
This package
Contains1250 mL Pack sizes2 compare ↓
Also comes in: 750 ml 47593-0681-41
OTC 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 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-0360-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 47593-681-59
Product NDC 47593-681
11-digit billing NDC 47593068159
RxCUI 1731737
UNII F5UM2KM3W7
Application # 505G(a)(3)
SPL Set ID 5fe2b669-6a7a-49a5-8374-ad6298944e5c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-12-31
Route TOPICAL
Dosage form SOLUTION
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 47593-681-59 — 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 → 47593-0681-59. 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.

🏭 Manufacturer & labeler

LabelerEcolab Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code47593
First marketedDec 2025
Product typeHuman Otc Drug
Portfolio115 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

🧪 What is this product?

Mystic Foaming Anti-Bacterial Handsoap is a topical liquid solution containing benzalkonium chloride, an antimicrobial agent commonly used in over-the-counter hand soaps and skin cleansers. Benzalkonium chloride functions as a broad-spectrum antimicrobial that is typically added to handsoaps to help reduce bacteria on the skin during washing. This product is marketed under the FDA's over-the-counter monograph rules for antiseptic hand-cleansing products, meaning it follows established safety and ingredient guidelines for this drug category.

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.

🧪 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 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: 750 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Advanced Antibacterial Foaming Hand Soap 5 mg/mL 47593-0543-41 Ecolab 750 ml FDA listed
Keystone 5 mg/mL 47593-0561-41 Ecolab 750 ml FDA listed
Facilipro 5 mg/mL 47593-0566-59 Ecolab 1250 ml FDA listed
PureForce 5 mg/mL 47593-0568-41 Ecolab 750 ml FDA listed
Members Mark 5 mg/mL 47593-0572-26 Ecolab 1000 ml FDA listed
Advanced Antibacterial Clean and Smooth 5 mg/mL 47593-0575-11 Ecolab 3780 ml FDA listed
Equi-Mild 5 mg/mL 47593-0582-38 Ecolab 500 ml FDA listed
Clean Force 5 mg/mL 47593-0584-41 Ecolab 750 ml FDA listed
Equi-Stat 5 mg/mL 47593-0585-31 Ecolab 540 ml FDA listed
Swisher 5 mg/mL 47593-0591-41 Ecolab 750 ml FDA listed
Keystone 5 mg/mL 47593-0594-11 Ecolab 3780 ml FDA listed
Keystone 5 mg/mL 47593-0595-41 Ecolab 750 ml FDA listed
Proclean 5 mg/mL 47593-0602-11 Ecolab 3780 ml FDA listed
Ecolab 5 mg/mL 47593-0613-41 Ecolab 750 ml FDA listed
Proclean Foaming Antibacterial Nexa 5 mg/mL 47593-0645-41 Ecolab 750 ml FDA listed
Ssdc Antibacterial Foam Handsoap 5 mg/mL 47593-0663-70 Ecolab 1200 ml FDA listed
Mystic Foaming Anti-Bacterial Handsoap 5 mg/mLthis 47593-0681-59 Ecolab 1250 ml FDA listed
EcoCare 280 5 mg/mL 47593-0646-11 Ecolab 3780 ml FDA listed
First Mark Ultra Foaming Antibacterial 5 mg/mL 51042-0001-10 Performance 1250 ml FDA listed
Swisher Advanced Antibacterial Foam Handsoap 5 mg/mL 47593-0696-41 Ecolab 750 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.

🔬 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 MYSTIC FOAMING ANTI-BACTERIAL HANDSOAP (this brand).

Top reported reactions

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

Age at onset

Infant1
Adolescent3
Adult36
Elderly10

Reporter sex

331 reports
Male · 28%
Female · 72%
Unknown · 0%

Serious outcomes

Hospitalization175
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
47593-0681-41 750 mL in 1 BOTTLE, PLASTIC (47593-681-41) 2025-12-31 Active
47593-0681-59 You're viewing this 1250 mL in 1 BOTTLE, PLASTIC (47593-681-59) 2025-12-31 Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 47593-0681-59?
NDC 47593-0681-59 contains 1250 mL — 1250 ml in 1 bottle, plastic.
What is the difference between NDC 47593-0681-59 and NDC 47593-0681-41?
Both are MYSTIC FOAMING ANTI-BACTERIAL HANDSOAP Benzalkonium Chloride 5 mg/mL Solution — the drug itself is identical. NDC 47593-0681-59 is the 1250 mL package, while NDC 47593-0681-41 is the 750 ml package.
What NDC number is used to bill for this package of MYSTIC FOAMING ANTI-BACTERIAL HANDSOAP Benzalkonium Chloride 5 mg/mL Solution?
Bill NDC 47593-0681-59 — the 11-digit billing format is 47593068159. 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 ✓ Available
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

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 FDA registers it as 47593-681-59, 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: 47593-0681-59, written without dashes as 47593068159. 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 47593-0681-59, the first segment (47593) is the labeler code FDA assigned to Ecolab Inc.; the middle segment (0681) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (59) 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 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 1 other package presentation of this same product, including 750 ml (47593-0681-41). 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.

📄 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 9 words

Uses for handwashing to decrease bacteria on the skin

⏱️ Dosage and Administration 14 words

Directions Wet hands and apply foam Scrub hands and forearms Rinse thoroughly and dry

⚠️ Warnings 66 words

Warnings For external use only Do not use in eyes When using the product if in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop Stop use and ask a docotr 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 0.5%

🧪 Inactive Ingredients 35 words

Inactive ingredients water (aqua), cocamine oxide, hexylene glycol, PEG-180, glycerin, cocamidopropyl PG-dimonium chloride phosphate, myristamine oxide, phenoxyethanol, polyquaternium 7, citric acid, myristamide DIPA, methyl gluceth-20, caprylic/capric glycerides, PEG-12 dimethicone, potassium hydroxide, fragrance, FD&C blue 1

🎯 Purpose 3 words

Purpose Antiseptic handwash

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.