Keystone Benzalkonium Chloride .1 mg/100mL Solution, 750 mL
by Ecolab Inc. · 750 mL in 1 BOTTLE, PLASTIC (47593-359-41)
NDC 47593-0359-41
🏷️ FDA NDC (as labeled)
47593-359-41
billing pads the product segment with a zero
This package
Contains750 mL
Pack sizes2 compare ↓
Also comes in:
1200 ml 47593-0359-56
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)
47593-359-41
Product NDC
47593-359
11-digit billing NDC
47593035941
UNII
F5UM2KM3W7
Application #
505G(a)(3)
SPL Set ID
b742f102-a60c-4ed0-8d6c-d6721c9ec5dc
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2002-07-26
Route
TOPICAL
Dosage form
SOLUTION
Substance
BENZALKONIUM CHLORIDE
Why two NDCs?
The FDA registers this code as 47593-359-41 — 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 → 47593-0359-41. 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 marketedJul 2002
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?
Keystone Benzalkonium Chloride is a liquid solution applied to the skin as an over-the-counter antiseptic and disinfectant product. Benzalkonium chloride is a quaternary ammonium compound that functions as an antimicrobial agent, typically used in topical products to help reduce bacteria on the skin and in minor wounds. This product is marketed under FDA's OTC monograph regulations, which allow it to be sold without individual drug approval based on established safety and use guidelines for this ingredient class.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Benzalkonium Chloride — tap one for details:
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 Benzalkonium Chloride?
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:
1200 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 |
|---|---|---|---|---|---|---|
| FoamFresh Alco-Free Hand Sanitizer 1 mg/mL 11429-1001-00 | Woodbine | 1125 ml | — | — | FDA listed | — |
| Summit 377Alcohol Free Foam Hand Sanitizer 1 mg/mL 23590-0600-10 | R.L. | 850 ml | — | — | FDA listed | — |
| Keystone .1 mg/100mLthis 47593-0359-41 | Ecolab | 750 ml | — | — | FDA listed | — |
| DigiSan E 1 mg/mL 47593-0404-41 | Ecolab | 750 ml | — | — | FDA listed | — |
| Foodservice Foam Hand Sanitizer .1 mg/100mL 47593-0470-41 | Ecolab | 750 ml | — | — | Discontinued | — |
| Pure Force 1 mg/mL 47593-0504-41 | Ecolab | 750 ml | — | — | FDA listed | — |
| Swisher 1 mg/mL 47593-0576-30 | Ecolab | 207 ml | — | — | FDA listed | — |
| Clean Force 1 mg/mL 47593-0586-41 | Ecolab | 750 ml | — | — | FDA listed | — |
| SSDC Foaming Hand Sanitizer 1 mg/mL 47593-0662-70 | Ecolab | 1250 ml | — | — | FDA listed | — |
| Kay Foaming Hand Sanitizer 1 mg/mL 47593-0670-59 | Ecolab | 1250 ml | — | — | FDA listed | — |
| SSDC Mystic Foaming Hand Sanitizer 1 mg/mL 47593-0674-41 | Ecolab | 750 ml | — | — | FDA listed | — |
| Ecolab Foaming Hand Sanitizer 1 mg/mL 47593-0677-59 | Ecolab | 1250 ml | — | — | FDA listed | — |
| MG FoamSan .1 g/100g 50241-0522-01 | Morgan | 3785 g | — | — | FDA listed | — |
| I.C. Hand Sanitizer 1 mg/mL 59555-0401-11 | R&R | 3785 ml | — | — | FDA listed | — |
| ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer 1 mg/mL 59555-0404-11 | R | 3785 ml | — | — | FDA listed | — |
| ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Cucumber Mint Bliss 1 mg/mL 59555-0405-11 | R | 3785 ml | — | — | FDA listed | — |
| ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Vanilla Sugar Bliss 1 mg/mL 59555-0406-11 | R | 3785 ml | — | — | FDA listed | — |
| ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Island Tranquility 1 mg/mL 59555-0407-11 | R | 3785 ml | — | — | FDA listed | — |
| ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Eucalyptus Tranquility 1 mg/mL 59555-0408-11 | R | 3785 ml | — | — | FDA listed | — |
| ForPro Professional Collection Alcohol-Free Foaming Instant Hand Sanitizer - Whispering Rose 1 mg/mL 59555-0409-11 | R | 3785 ml | — | — | FDA listed | — |
| Simple Hygiene Alcohol Free Foam Hand Sanitizer 1 mg/mL 60933-0018-01 | FULLER | 237 ml | — | — | FDA listed | — |
| Alcohol Free Hand Sanitizer 1 mg/mL 60933-0200-00 | FULLER | 1000 ml | — | — | FDA listed | — |
| Sani-Foam Foaming Non-Alcohol Hand Sanitizer 1 mg/mL 62767-0104-31 | Multi-Clean | 50 ml | — | — | FDA listed | — |
| Life is Simple Hand Sanitizer 1 mg/mL 63148-0500-10 | Apollo | 296 ml | — | — | FDA listed | — |
| Alcohol-Free Hand Sanitizing Foam 1 mg/mL 63998-0764-01 | United | 59 ml | — | — | FDA listed | — |
| Lite n Foamy Non-Alcohol Hand Sanitizer 1 g/1000g 64009-0222-82 | Spartan | 532 g | — | — | FDA listed | — |
| Lite nFoamy E3 Hand Sanitizer 1 g/L 64009-0334-05 | Spartan | 3.79 l | — | — | FDA listed | — |
| WhiskCare 377 1 mg/mL 65585-0356-01 | Whisk | 50 ml | — | — | FDA listed | — |
| Sani-Sure AF 1 mg/mL 65585-0360-01 | Whisk | 1000 ml | — | — | FDA listed | — |
| WhiskCare 377 Free 1 mg/mL 65585-0527-01 | Whisk | 1000 ml | — | — | FDA listed | — |
| WhiskCare 377 Free 1 mg/mL 65585-0528-01 | Whisk | 1000 ml | — | — | FDA listed | — |
| WhiskCare 377 1 mg/mL 65585-0529-01 | Whisk | 50 ml | — | — | FDA listed | — |
| MyTerra Hand Sanitizer Foam NA 1 mg/mL 70780-0151-13 | PortionPac | 1000 ml | — | — | FDA listed | — |
| Sani Luxe Foaming Hand Sanitizer Alcohol Free 1 mg/mL 71489-0006-01 | Celeste | 237 ml | — | — | FDA listed | — |
| LOCKE TEDDY Foaming Hand Sanitizer .1 g/100mL 73928-0011-01 | KINGKEY | 30 ml | — | — | FDA listed | — |
| Servo Stat BAC 1 mg/mL 76378-0023-01 | Enzyme | 473 ml | — | — | FDA listed | — |
| Hillyard Alcohol Free Foaming Instant Hand Sanitizer .1 g/100mL 76402-0403-02 | Hillyard | 1000 ml | — | — | FDA listed | — |
| Healthy Hands Foaming Hand Sanitizer .1 g/100g 77617-0001-02 | Maintex | 4 bottles | — | — | FDA listed | — |
| Servo Stat BAC 1 mg/mL 78041-0023-01 | Fusion | 3875 ml | — | — | FDA listed | — |
| Decon7 Antiseptic Foaming Hand Sanitizer 1 mg/mL 78245-0201-01 | Decon7 | 50 ml | — | — | FDA listed | — |
| Lavex Alcohol Free Foaming Instant Hand Sanitizer 1 mg/mL 81551-0377-01 | Clark | 1000 ml | — | — | FDA listed | — |
| Reliance Hand Saniziter .1 mg/100mL 47593-0478-41 | Ecolab | 750 ml | — | — | FDA listed | — |
| CHEMSTAR Foaming Hand Sanitizer .1 mg/100mL 47593-0689-59 | Ecolab | 1250 ml | — | — | FDA listed | — |
| EXP Foaming Hand Sanitizer .1 mg/100mL 47593-0692-70 | Ecolab | 1200 ml | — | — | FDA listed | — |
| ProClean Foam Nexa Hand Sanitizer .1 mg/100mL 47593-0657-41 | 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
🏛️
2002
On the market since
Jul 2002
📍
2026
Currently FDA-listed
24 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 Keystone (this brand).
Top reported reactions
Reporter sex
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 |
|---|---|---|---|
| 47593-0359-41 You're viewing this | 750 mL in 1 BOTTLE, PLASTIC (47593-359-41) | 2002-07-26 | Active |
| 47593-0359-56 | 1200 mL in 1 BOTTLE, PLASTIC (47593-359-56) | 2002-07-26 | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 47593-0359-41?
NDC 47593-0359-41 contains 750 mL — 750 ml in 1 bottle, plastic.
What is the difference between NDC 47593-0359-41 and NDC 47593-0359-56?
Both are Keystone Benzalkonium Chloride .1 mg/100mL Solution — the drug itself is identical. NDC 47593-0359-41 is the 750 mL package, while NDC 47593-0359-56 is the 1200 ml package.
What NDC number is used to bill for this package of Keystone Benzalkonium Chloride .1 mg/100mL Solution?
Bill NDC 47593-0359-41 — the 11-digit billing format is 47593035941. 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 47593-359-41, 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: 47593-0359-41, written without dashes as 47593035941. 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 47593-0359-41, the first segment (47593) is the labeler code FDA assigned to Ecolab Inc.; the middle segment (0359) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (41) 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 1200 ml (47593-0359-56). 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
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses for handwashing to decrease bacteria on the skin
⏱️ Dosage and Administration ▾
Directions wash hands to remove soil dispense 20 mL into hand (palmful) spread to cover hands, rub in well for at least 30 seconds air dry, do not rinse or towel dry
⚠️ Warnings ▾
Warnings For external use only Do not use in eyes When using this product discontinue use if irritation and redness develop Stop use and ask a doctor if irritation and redness develop
🧪 Active Ingredient ▾
Active ingredient Benzalkonium chloride 0.1%
🧪 Inactive Ingredients ▾
Inactive ingredients water (aqua), isopropyl alcohol, propylene glycol, red 40, blue 1
🎯 Purpose ▾
Purpose Antiseptic handwash
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.