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Antibacterial Lotions Skin Cleanser Chloroxylenol 4 mg/mL Soap, 1100 mL — NDC 65601-0841-10 package photo

Antibacterial Lotions Skin Cleanser Chloroxylenol 4 mg/mL Soap, 1100 mL

by Betco Corporation, Ltd. · 1100 mL in 1 BAG (65601-841-10)
NDC 65601-0841-10
🏷️ FDA NDC (as labeled) 65601-841-10 billing pads the product segment with a zero
This package
Contains1100 mL Pack sizes6 compare ↓
Also comes in: 500 ml 65601-0841-88 900 ml 65601-0841-19 1000 ml 65601-0841-29 3780 ml 65601-0841-04 207900 ml 65601-0841-55
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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

🆔 Identity & classification

FDA NDC (as labeled) 65601-841-10
Product NDC 65601-841
11-digit billing NDC 65601084110
UNII 0F32U78V2Q
UPC 0700427141552, 0700427023391, 0700427141194, 0700427031709 +1 more
Application # 505G(a)(3)
SPL Set ID 1b2d1076-2c8b-8869-e063-6394a90a1ac4
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-11-12
Route TOPICAL
Dosage form SOAP
Substance CHLOROXYLENOL
Why two NDCs? The FDA registers this code as 65601-841-10 — 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 → 65601-0841-10. 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.

🏭 Manufacturer & labeler

LabelerBetco Corporation, Ltd.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code65601
First marketedNov 2012
Product typeHuman Otc Drug
Portfolio4 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?

This is an over-the-counter soap cleanser containing chloroxylenol, an antimicrobial ingredient applied topically to the skin. Chloroxylenol is commonly used in antibacterial soaps and lotions to help reduce bacteria on the skin during washing. As an OTC monograph product, it is marketed under established FDA guidelines for antibacterial cleansers rather than as an individually reviewed drug application. The product is intended for routine skin cleansing and hygiene use.

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.

🧪 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 WC51CA3418
    A fragrance compound derived from cinnamon, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII 7X6O37OK2I
    A synthetic fragrance compound used as a flavoring agent or aromatic component in medicines. It adds pleasant taste or smell to make the medication more acceptable to patients.
  • UNII 565OK72VNF
    A natural-origin fragrance compound derived from plants like citronella and geranium. Used as a flavoring agent and fragrance ingredient to improve taste or aroma in medications.
  • UNII QB1T0AG2YL
    A naturally occurring compound used in medicines as a flavoring agent to mask bitter or unpleasant tastes. It may also serve as a fragrance component in certain formulations.
  • UNII 1GD7ODM28Y
    A natural compound derived from plant sources, typically used as a flavoring agent or fragrance component to enhance the taste or aroma of medicines.
  • UNII Z331YX9EL9
    A synthetic fragrance compound used as a flavoring agent in medicines. It provides taste and aroma to make oral medications more palatable, particularly in liquid formulations or chewable products.
  • UNII VK5ZHH2T3F
    A synthetic organic compound used as a fragrance or flavoring agent in medicines. It provides aroma or taste to mask unpleasant flavors and improve patient acceptance of the medication.
  • UNII 364FV60913
    A synthetic chemical compound used primarily as a fragrance ingredient and solvent in pharmaceutical formulations. It helps dissolve other components and contributes scent to improve the taste or appeal of oral medicines.
  • UNII L65EG8H6PA
    A synthetic organic compound used as a flavoring agent in medicines. It provides a distinctive aromatic taste to help mask unpleasant flavors and improve patient acceptance of oral formulations.
  • UNII 30E3255185
    A synthetic organic compound used as a fragrance or flavoring agent in medicines. It provides pleasant taste or smell to make the medication more palatable for patients.
  • UNII 0ECG3V79ZJ
    Benzyl acetate is a clear liquid chemical used as a solvent and fragrance component in medicines. It helps dissolve other ingredients and may contribute to the product's smell or taste.
  • UNII WAO5MNK9TU
    Benzyl salicylate is a fragrant chemical compound used as a flavor and scent ingredient in medicines. It helps mask unpleasant tastes or odors in liquid or oral formulations.
  • UNII S4255P4G5M
    Calcium silicate is a white powder made from calcium and silicon compounds. It acts as an anti-caking agent and flow aid, helping powder ingredients move smoothly during tablet or capsule manufacturing.
  • 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 M4SL82J7HK
    A foaming and cleansing agent derived from coconut oil. It's used in liquid formulations to create texture, improve spreadability, and help distribute active ingredients evenly throughout the product.
  • UNII 8J6RDU8L9X
    A synthetic green dye used to color medications. It helps make pills and capsules visually distinct so patients can easily identify their medicine.
  • UNII 46L1B02ND9
    A synthetic fragrance ingredient derived from myrcene, a natural plant oil. It adds a fresh, woody scent to the medicine and helps mask unpleasant flavors or odors of active ingredients.
  • UNII 9A87HC7ROD
    A synthetic compound used as a plasticizer and conditioning agent in tablet coatings and film formulations. It helps make coatings flexible and improves how they cling to the tablet surface.
  • UNII JJH7GNN18P
    Ethylene oxide is a sterilizing gas used to eliminate bacteria, viruses, and other microorganisms from medical devices and some pharmaceutical equipment during manufacturing. It helps ensure the final medicine is free from harmful contamination.
  • 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 13W7MDN21W
    A waxy compound made from glycol and stearic acid. It's used as an emulsifier to help blend oil and water-based ingredients, and as a thickener to give the medicine its desired texture and consistency.
  • UNII S3ASM14UAS
    A synthetic chemical compound used as an inactive ingredient in medications. It typically serves as a fragrance or flavoring agent to improve the taste or smell of the medicine.
  • UNII 8F78EY72YL
    Hexyl salicylate is a synthetic compound used as a fragrance ingredient in medications. It provides pleasant odor and taste to make medicines more acceptable to take.
  • UNII 82DUX3RRVU
    A cleansing agent derived from lauric acid and isopropanolamine. It helps remove oils and impurities in topical formulations and may act as an emulsifier to mix water and oil-based ingredients together.
  • UNII D81QY6I88E
    Linalool is a natural fragrant oil found in plants like lavender and citrus. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII ML9LGA7468
    A naturally-derived alcohol used as a preservative and fragrance in medicines. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • 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 058TS43PSM
    Sodium aluminosilicate is a mineral-based powder used as an anti-caking agent and flow improver in solid medicines. It absorbs moisture and prevents clumping, helping tablets and capsules remain dry and easy to handle.
  • 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 45P3261C7T
    Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII BPV390UAP0
    Sodium laureth sulfate is a mild detergent and surfactant derived from coconut oil or petroleum. It helps mix oil and water in formulations and is often used as a cleaning or foaming agent in topical products like shampoos and cleansers.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 91D9GV0Z28
    A mineral salt made from calcium and phosphate. It acts as a filler to add bulk to the tablet or capsule, and helps bind ingredients together so the medicine holds its shape.
  • UNII 5232EN3X2F
    A synthetic compound used as a colorant and flavoring agent in medications. It provides green coloring and may contribute fruity or herbal taste characteristics to tablets, capsules, or liquid 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.

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

The official label also statesWater, Sodium Chloride, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Ethylene Glycol Phenyl Ether, Glycerin, Fragrance, Propylene Glycol, Sodium Hydroxide, Cocamidopropylamine Oxide, Sodium Benzoate, Glycol Distearate, Lauramide MIPA, Disodium Cocamido MIPA Sulfosuccinate, D&C Green 5, FD&C Yellow 5.

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.

💲 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: 500 ml 900 ml 1000 ml 3780 ml 207900 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
Antibacterial Lotions Skin Cleanser 4 mg/mLthis 65601-0841-10 Betco 1100 ml — — FDA listed —
Zep Round One Ab .4 g/100mL 66949-0129-24 Zep 15140 ml — — FDA listed —
Antibacterial Skin Cleanser 4 mg/mL 72024-0708-04 Fastenal 3780 ml — — FDA listed —
Pearlized Antibacterial Skin Cleanser 4 mg/mL 72024-0841-04 Fastenal 3780 ml — — FDA listed —
KleenLine Essentials Antibacterial LotionSkin Cleanser 4 mg/mL 79258-0841-04 Brady 3785 ml — — FDA listed —
Unitex Antibacterial LotionHandSoap 4 mg/mL 84955-0841-04 Jon-Don 3780 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

🏛️
2012
On the market since
Nov 2012
📍
2026
Currently FDA-listed
14 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65601-0841-04 3780 mL in 1 JUG (65601-841-04) 2016-02-01 Active
65601-0841-10 You're viewing this 1100 mL in 1 BAG (65601-841-10) 2016-02-01 Active
65601-0841-19 900 mL in 1 BAG (65601-841-19) 2016-02-01 Active
65601-0841-29 1000 mL in 1 BAG (65601-841-29) 2012-11-12 Active
65601-0841-55 207900 mL in 1 DRUM (65601-841-55) 2016-02-01 Active
65601-0841-88 500 mL in 1 BOTTLE, PUMP (65601-841-88) 2020-09-11 Active

You're viewing one of 6 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 65601-0841-10?
NDC 65601-0841-10 contains 1100 mL — 1100 ml in 1 bag.
What is the difference between NDC 65601-0841-10 and NDC 65601-0841-88?
Both are Antibacterial Lotions Skin Cleanser Chloroxylenol 4 mg/mL Soap — the drug itself is identical. NDC 65601-0841-10 is the 1100 mL package, while NDC 65601-0841-88 is the 500 ml package.
What NDC number is used to bill for this package of Antibacterial Lotions Skin Cleanser Chloroxylenol 4 mg/mL Soap?
Bill NDC 65601-0841-10 — the 11-digit billing format is 65601084110. 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) ✓ 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 65601-841-10, 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: 65601-0841-10, written without dashes as 65601084110. 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 65601-0841-10, the first segment (65601) is the labeler code FDA assigned to Betco Corporation, Ltd.; the middle segment (0841) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 Betco Corporation, Ltd.. 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 500 ml (65601-0841-88), 900 ml (65601-0841-19), 1000 ml (65601-0841-29). 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?
Betco Corporation, Ltd. 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 17 words ▾

Uses ​ ​Antibacterial hand cleaner. Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics

⏱️ Dosage and Administration 31 words ▾

Directions ​Read the entire label before using this product. ​Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands. Rinse with clean water.

⚠️ Warnings 63 words ▾

Warnings For external use only. Avoid contact with eyes. Children under the age of 6 should be supervised by an adult when using this product. Discontinue use is irritation or redness develops. If irritation persists for more than 72 hours, consult a physician. KEEP OUT OF REACH OF CHILDREN . If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 4 words ▾

Active Ingredient Chloroxylenol 0.40%

🧪 Inactive Ingredients 41 words ▾

Inactive Ingredients Water, Sodium Chloride, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Ethylene Glycol Phenyl Ether, Glycerin, Fragrance, Propylene Glycol, Sodium Hydroxide, Cocamidopropylamine Oxide, Sodium Benzoate, Glycol Distearate, Lauramide MIPA, Disodium Cocamido MIPA Sulfosuccinate, D&C Green 5, FD&C Yellow 5.

🎯 Purpose 2 words ▾

Purpose Antibacterial

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65601-0817-04 · Betco 65603-0100-01 · Arkansas →
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.