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E2 SANITIZING HAND .003 mg/mL Soap, 4000 mL — NDC 50865-0017-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

E2 SANITIZING HAND .003 mg/mL Soap, 4000 mL — NDC 50865-017-07 (Billing 50865-0017-07)

by KUTOL PRODUCTS COMPANY · 4000 mL in 1 BOTTLE, PLASTIC

This is a package of 4,000 mL of E2 SANITIZING HAND .003 mg/mL Soap from KUTOL PRODUCTS COMPANY, marketed since Sep 2015 and currently FDA-listed.

NDC 50865-0017-07
🏷️ FDA NDC (as labeled) 50865-017-07 billing pads the product segment with a zero
This package
Contains4000 mL Pack sizes6 compare ↓
Product page 50865-0017-03 Also comes in: 800 ml 50865-017-65 1000 ml 50865-017-41 2000 ml 50865-017-67 4000 ml 50865-017-09 209000 ml 50865-017-03
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 50865-017-07 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
50865 labeler · 017 product · 07 package
Package marketed since
Sep 15, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0686702017074, 0686702017098
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50865-017-07
Product NDC 50865-017
11-digit billing NDC 50865001707
UNII F5UM2KM3W7
UPC 0686702017074, 0686702017098
Application # 505G(a)(3)
SPL Set ID 70357eaf-8cd8-4c5e-b7a8-ae2fbba0ca2e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-09-15
Route TOPICAL
Dosage form SOAP
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 50865-017-07 — 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 → 50865-0017-07. 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?

E2 Sanitizing Hand Soap is a topical soap product containing benzalkonium chloride, an antimicrobial ingredient. Benzalkonium chloride is commonly used in hand sanitizers and antimicrobial soaps to help reduce bacteria on the skin. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for antiseptic hand-care products rather than going through individual approval.

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 eachPer 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: 800 ml 1000 ml 2000 ml 4000 ml 209000 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
50865-0017-03 50865-017-03 Main listing 209000 mL in 1 DRUM 2015-09-15 — Active
50865-0017-07 You're viewing this 4000 mL in 1 BOTTLE, PLASTIC 2015-09-15 — Active
50865-0017-09 50865-017-09 4000 mL in 1 BOTTLE, PLASTIC 2015-09-15 — Active
50865-0017-41 50865-017-41 1000 mL in 1 BAG 2015-09-15 — Active
50865-0017-65 50865-017-65 800 mL in 1 BAG 2015-09-15 — Active
50865-0017-67 50865-017-67 2000 mL in 1 BOTTLE, PLASTIC 2015-09-15 — Active

Pack size FAQ

What quantity is in this package?
This package contains 4000 mL — 4000 ml in 1 bottle, plastic.
How does this package differ from NDC 50865-0017-65?
Both are E2 SANITIZING HAND .003 mg/mL Soap — the drug itself is identical. This page's package is the 4000 mL one, while NDC 50865-0017-65 is the 800 ml package.
What NDC number is used to bill for this package of E2 SANITIZING HAND .003 mg/mL Soap?
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
E2 Sanitizing Hand .003 mg/mLthis 50865-0017-07 KUTOL 4000 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
Sep 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 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • 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 12VCE9HR9E
    A plant-derived thickening agent made from cellulose, a natural fiber. It increases the thickness and consistency of liquid or semi-solid medicines, helping them spread evenly and stay on the skin or in the mouth longer.
  • UNII 603P14DHEB
    A synthetic antimicrobial chemical used as a preservative in topical and cosmetic formulations. It prevents bacterial and fungal growth in products to maintain stability and safety during storage and use.
  • UNII A81MSI0FIC
    A quaternary ammonium compound derived from lauryl alcohol. It acts as an antimicrobial preservative and antistatic agent to help keep the product stable and prevent microbial growth during storage.
  • UNII 229D0E1QFA
    Methylisothiazolinone is a synthetic chemical preservative that prevents bacterial and fungal growth in liquid medicines and topical products. It helps keep the medication safe and extends shelf life during storage.
  • UNII YZ6NLA4O1E
    A plant-derived emulsifier made from coconut oil and polyethylene glycol. It helps blend oil and water ingredients together and improves how the medicine spreads or absorbs.
  • 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.

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

The official label also statesWater, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocamidopropyl Betaine, PEG-6 Cocamide, Hydroxyethyl Cellulose, Laurtrimonium Chloride, Iodopropynyl Butylcarbamate, Methylisothiazolinone.

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

LabelerKUTOL PRODUCTS COMPANY
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code50865
First marketedSep 2015
Product typeHuman Otc Drug
Portfolio7 products on file

More NDCs from KUTOL PRODUCTS COMPANY labeler code 50865

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 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

Uses For handwashing to help reduce bacteria on the skin that could cause disease.

⏱️ Dosage and Administration 20 words ▾

Directions To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

⚠️ Warnings 51 words ▾

Warnings For external use only. Avoid contact with eyes. If contact occurs, flush with water. Stop use and ask a doctor if, in rare instances, redness or irritation develops and persists for more than 72 hours. Keep out of reach of children. If swallowed, contact a physician or poison control center.

🧪 Active Ingredient 6 words ▾

Active Ingredient Benzalkonium Chloride 0.13% w/w

🧪 Inactive Ingredients 18 words ▾

Inactive Ingredients Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocamidopropyl Betaine, PEG-6 Cocamide, Hydroxyethyl Cellulose, Laurtrimonium Chloride, Iodopropynyl Butylcarbamate, Methylisothiazolinone.

🎯 Purpose 3 words ▾

Purpose Antibacterial Agent

📄 Stop Use and Ask a Doctor If 21 words ▾

Stop use and ask a doctor if, in rare instances, redness or irritation develops and persists for more than 72 hours.

📄 Keep Out of Reach of Children 15 words ▾

Keep out of reach of children. If swallowed, contact a physician or poison control center.

📄 Questions or Comments 7 words ▾

Kutol Product Co. Cincinnati, OH 45241 www.Kutol.com

📄 Package Label / Principal Display Panel 20 words ▾

1703 label 1703 label

1707 label 1707 label

1709 label 1709 label

1765 label 1765 label

1767 label 1767 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 KUTOL PRODUCTS COMPANY. 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 5 other package presentations of this same product, including 800 ml (50865-0017-65), 1000 ml (50865-0017-41), 2000 ml (50865-0017-67). 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?
KUTOL PRODUCTS COMPANY 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.
← 50845-0286-02 · Liddell 50865-0025-03 · Kutol →
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.