HomeNDC LookupIngredientsChloroxylenol › 59503-0544-07
Chemseptic CHLOROXYLENOL 3 mg/mL Soap, 75600 mL — NDC 59503-0544-07 package photo

Chemseptic CHLOROXYLENOL 3 mg/mL Soap, 75600 mL

by Rochester Midland Corporation · 75600 mL in 1 DRUM (59503-0544-7)
NDC 59503-0544-07
🏷️ FDA NDC (as labeled) 59503-0544-7 billing pads the package segment with a zero
This package
Contains75600 mL Pack sizes9 compare ↓
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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 →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 59503-0544-7
Product NDC 59503-0544
11-digit billing NDC 59503054407
RxCUI 413261
UNII 0F32U78V2Q
Application # M003
SPL Set ID f3109c8d-c684-47a7-b26a-32e3ba64b838
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2004-03-30
Route TOPICAL
Dosage form SOAP
Substance CHLOROXYLENOL
Why two NDCs? The FDA registers this code as 59503-0544-7 — a 5-4-1 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 package segment → 59503-0544-07. 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.

🏷️ RxNorm drug class

This medicine belongs to the Phenol and derivatives class.

Drug family (ATC) Phenol and derivatives
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

LabelerRochester Midland Corporation
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code59503
First marketedMar 2004
Product typeHuman Otc Drug
Portfolio3 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?

Chemseptic Chloroxylenol 3 mg/mL Soap is a topical soap product containing chloroxylenol, an antimicrobial agent. This over-the-counter monograph drug is typically used as a cleansing and antiseptic soap for routine hand and skin washing. Chloroxylenol is commonly found in consumer antimicrobial soaps and functions as a broad-spectrum antimicrobial to help reduce bacteria and other microorganisms on the skin surface.

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 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.
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
Lemon Drop Gentle Antiseptic 3 mg/mL 11429-1006-01 Woodbine 118 ml FDA listed
Simplify Antibacterial Hand Apple Blossom Scent .3 g/100mL 11822-0281-01 Rite 573 ml Discontinued
Antiseptic Hand 3 mg/mL 16496-0544-14 Image 3785 ml FDA listed
Renown Antibacterial Hand 3000 mg/L 18949-0051-00 HD 3.78 l FDA listed
Symmetry Antimicrobial Foaming Hand Wash .3 g/100mL 30805-0006-02 Buckeye 1250 ml FDA listed
Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX .3 g/100mL 30805-0016-02 Buckeye 1250 ml Discontinued
Sentry Antiseptic Handsoap 3 mg/mL 31507-0544-14 Wechem, 3785 ml FDA listed
Hand Guard High Foaming Antiseptic Hand and Body Wash 3 mg/mL 31507-0876-01 Wechem, 1200 ml Discontinued
Chloroxylenol 0.30 % 3 mg/mL 42669-0028-03 Davion, 828 ml FDA listed
Fm-24 Foaming 3 mg/mL 43097-0876-01 People's 1200 ml Discontinued
Sani Foam Mango Antiseptic Hand and Body Wash 3 mg/mL 43374-0876-10 Delta 1000 ml Discontinued
Pearl Antimicrobial Hand Item 1027Ab-01 .3 g/100mL 50536-0127-01 AMERICAN 3785 ml FDA listed
Soft Touch Plus Antibacterial Hand Item 1039 .3 g/100mL 50536-0139-01 AMERICAN 3785 ml FDA listed
Super Suds Antibacterial Hand Item 1063 .3 g/100mL 50536-0163-01 AMERICAN 3785 ml FDA listed
E-2 Hand Item 1095 .3 g/100mL 50536-0195-01 AMERICAN 3785 ml FDA listed
Golden Medicated .3 g/100mL 50865-0060-09 Kutol 3785 ml FDA listed
Xtra Antibacterial Hand Juicy Orange 3 mg/mL 51628-0033-00 MY 709 ml FDA listed
Ultra 3 mg/mL 55910-0589-44 Old 532 ml FDA listed
Triclosan Free Antibacterial Antibacterial .3 g/100mL 57337-0086-01 Rejoice 443 ml FDA listed
Triclosan Free Antibacterial 7.5 oz original Antibacterial .3 g/100mL 57337-0087-01 Rejoice 221 ml FDA listed
Triclosan Free Antibacterial 7.5 oz (Ocean) Antibacterial .3 g/100mL 57337-0088-01 Rejoice 221 ml FDA listed
Triclosan Free Antibacterial 7.5 oz (Strawberry Pomegranate) Antibacterial .3 g/100mL 57337-0089-01 Rejoice 221 ml FDA listed
Triclosan Free Antibacterial 7.5 oz (Fresh Citrus) Antibacterial .3 g/100mL 57337-0090-01 Rejoice 221 ml FDA listed
Chemseptic 3 mg/mLthis 59503-0544-07 Rochester 75600 ml Discontinued
Antibacterial Foamy Mango High Foaming Antiseptic Hand and Body Wash 3 mg/mL 60456-0876-01 Carpet 1200 ml Discontinued
Franklin cleaning technology antibacterial hand 3 mg/mL 60933-0056-00 Fuller 3790 ml FDA listed
1012 Antimicrobial 3 mg/mL 62257-0012-06 ABC 800 ml Discontinued
Lynx Antibacterial 3 mg/mL 62257-0160-01 ABC 1200 ml Discontinued
Lynx Foamy PCMX Antiseptic Hand and Body Wash 6876 3 mg/mL 62257-0161-01 ABC 1200 ml Discontinued
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380 3 mg/mL 62257-0380-12 ABC 1000 ml FDA listed
Palm 3 mg/mL 62257-0544-06 ABC 800 ml FDA listed
Lynx LX0864 peachy-foam antiseptic handsoap 3 mg/mL 62257-0686-12 ABC 1000 ml FDA listed
Sani Mango Antiseptic Hand and Body Wash 3 mg/mL 62257-0875-01 ABC 1200 ml Discontinued
Sani Mango Antiseptic Hand and Body Wash 3 mg/mL 62257-0876-01 ABC 1200 ml FDA listed
Handtastic Foamy Mango Antiseptic Hand and Body Wash 3 mg/mL 63533-0876-01 Momar 1200 ml Discontinued
Suds High Foaming Antiseptic Hand and Body Wash 3 mg/mL 63830-0876-01 Pro 1200 ml Discontinued
Fresh Start 3 mg/mL 63830-0950-06 Pro 800 ml FDA listed
Surgent Antiseptic 3 mg/mL 66155-0544-01 SunCoast 1200 ml Discontinued
Zep Applaud AB .3 g/100mL 66949-0123-01 Zep 11400 ml FDA listed
Inoderm Style Antibacterial 3 mg/.001L 73062-0055-00 Avro 3.8 l FDA listed
Inoderm Choice Antibacterial 3 mg/mL 73062-0523-42 Avro 3800 ml FDA listed
Kroger Antibacterial Green Apple Hand .3 g/100mL 73487-0001-01 Korex 709 ml Discontinued
Power Force Antibacterial Handsoap Green Apple Scent .3 g/100mL 73487-0008-01 Korex 709 ml FDA listed
Power Force Antibacterial Handsoap Citrus Scent .3 g/100mL 73487-0009-01 KOREX 709 ml FDA listed
Freshands Premium Foamy Antibacterial Handsoap 6876 3 mg/mL 75632-0876-14 Consolidated 3785 ml Discontinued
Satin Foam High Foaming Antiseptic Hand Wash 3 mg/mL 75990-0914-03 Certus 750 ml FDA listed
Green Antibacterial Dish and HandSoap 30 mg/10mL 79481-0200-02 Meijer, 709 ml FDA listed
TOTO Antibacterial Foam HandSoap 3 mg/mL 84791-0686-05 Toto 18927 ml FDA listed
Ban-Aid 3 mg/mL 63830-0544-06 Pro 800 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

🏛️
2004
On the market since
Mar 2004
📍
2026
Currently FDA-listed
22 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 Chemseptic (this brand).

Top reported reactions

Vomiting2
Abdominal Pain Lower1
Abdominal Pain Upper1
Anaemia1
Cholecystitis1
Cystitis1
Drug Effect Decreased1

Age at onset

Elderly1

Reporter sex

7 reports
Male · 14%
Female · 86%

Serious outcomes

Hospitalization3
Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2025 2026 2 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
59503-0544-01 532 mL in 1 BOTTLE, PLASTIC (59503-0544-1) 2004-03-30 Discontinued by firm
59503-0544-02 3785 mL in 1 BOTTLE, PLASTIC (59503-0544-2) 2004-03-30 Active
59503-0544-03 18900 mL in 1 PAIL (59503-0544-3) 2004-03-30 Discontinued by firm
59503-0544-04 208200 mL in 1 DRUM (59503-0544-4) 2004-03-30 Discontinued by firm
59503-0544-05 946 mL in 1 BOTTLE, PLASTIC (59503-0544-5) 2004-03-30 Discontinued by firm
59503-0544-06 2500 mL in 1 BOTTLE, PLASTIC (59503-0544-6) 2004-03-30 Active
59503-0544-07 You're viewing this 75600 mL in 1 DRUM (59503-0544-7) 2004-03-30 Discontinued by firm
59503-0544-08 132500 mL in 1 DRUM (59503-0544-8) 2004-03-30 Active
59503-0544-09 650 mL in 1 BAG (59503-0544-9) 2004-03-30 Discontinued by firm

You're viewing one of 9 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 59503-0544-07?
NDC 59503-0544-07 contains 75600 mL — 75600 ml in 1 drum.
What is the difference between NDC 59503-0544-07 and NDC 59503-0544-01?
Both are Chemseptic CHLOROXYLENOL 3 mg/mL Soap — the drug itself is identical. NDC 59503-0544-07 is the 75600 mL package, while NDC 59503-0544-01 is the 532 ml package.
What NDC number is used to bill for this package of Chemseptic CHLOROXYLENOL 3 mg/mL Soap?
Bill NDC 59503-0544-07 — the 11-digit billing format is 59503054407. 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 No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 59503-0544-7, 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: 59503-0544-07, written without dashes as 59503054407. 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 59503-0544-07, the first segment (59503) is the labeler code FDA assigned to Rochester Midland Corporation; the middle segment (0544) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 8 other package presentations of this same product, including 532 ml (59503-0544-01), 650 ml (59503-0544-09), 946 ml (59503-0544-05). 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?
Rochester Midland Corporation 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 15 words

Drug Facts Box OTC-Indications & Usage Section for hand-washing to decrease bacteria on the skin

⏱️ Dosage and Administration 28 words

Drug Facts Box OTC-Dosage & Administration Section wet hands and forearms apply 5 milliliters (teaspoonful) or palmful to hands and forearms scrub thoroughly for 1 minute and rinse

⚠️ Warnings 9 words

Drug Facts Box OTC-Warnings Section For external use only

🧪 Active Ingredient 8 words

Drug Facts Box OTC-Active Ingredient Section Chloroxylenol 0.3%

🧪 Inactive Ingredients 29 words

Drug Facts Box OTC-Inactive Ingredient Section water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, sodium chloride, citric acid, fragrance, FD and C yellow no.5, FD&C Red 40

🎯 Purpose 6 words

Drug Facts Box OTC-Purpose Section Antiseptic

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.