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Clean Xpress Antiseptic Hand Cleaner Chloroxylenol 10 mg/mL Soap — NDC 64009-0338-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clean Xpress Antiseptic Hand Cleaner Chloroxylenol 10 mg/mL Soap — NDC 64009-338-02 (Billing 64009-0338-02)

by Spartan Chemical Company, Inc. · 12 BAG in 1 BOX / 1000 mL in 1 BAG

This is a package of Clean Xpress Antiseptic Hand Cleaner Chloroxylenol 10 mg/mL Soap from Spartan Chemical Company, Inc., marketed since Apr 2020 and currently FDA-listed. It is this product's only package size.

NDC 64009-0338-02
🏷️ FDA NDC (as labeled) 64009-338-02 billing pads the product segment with a zero
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64009-338-02
Product NDC 64009-338
11-digit billing NDC 64009033802
RxCUI 413257
UNII 0F32U78V2Q
Application # 505G(a)(3)
SPL Set ID b0a70513-9530-4209-90c9-3cf2fd9895e5
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-04-20
Route TOPICAL
Dosage form SOAP
Substance CHLOROXYLENOL
Quick answers
  • RxCUI (RxNorm): 413257
Why two NDCs? The FDA registers this code as 64009-338-02 — 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 → 64009-0338-02. 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.

Clinical

🧪 What is this product?

Clean Xpress Antiseptic Hand Cleaner is a topical soap containing chloroxylenol, an antimicrobial agent. This over-the-counter monograph product is typically used to cleanse and reduce germs on the skin of the hands. Chloroxylenol is commonly found in antiseptic and antibacterial hand cleansers and soaps intended for routine handwashing and hygiene.

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.
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
64009-0338-02 You're viewing this Main listing 12 BAG in 1 BOX / 1000 mL in 1 BAG 2020-04-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Kindest Kare Hand Antimicrobial Handwash 1 g/100mL 11084-0036-41 SC 1000 ml — — FDA listed —
Acute-Kare Healthcare Personnel Handwash 1 g/100mL 11084-0800-41 SC 1000 ml — — FDA listed —
DigiClean E 1 mg/100mL 47593-0308-41 Ecolab 750 ml — — FDA listed —
Ecolab 10 mg/mL 47593-0506-41 Ecolab 750 ml — — FDA listed —
VioNexus 1 g/100mL 55443-0600-03 Metrex 2 bottles — — FDA listed —
SoftenSure Foam Antimicrobial 10 mg/mL 59900-0127-05 Best 1250 ml — — FDA listed —
Soften Sure Foam Antimicrobial 10 g/1000mL 59900-0211-06 Best 1000 ml — — FDA listed —
Prestige 10 mg/mL 63621-0335-14 Sunburst 3785 ml — — FDA listed —
FoamyIQ Healthcare Personnel Handwash 10.11 g/L 64009-0203-06 Spartan 1.25 l — — FDA listed —
Lite nFoamy Healthcare Personnel Handwash 10.11 g/L 64009-0335-82 Spartan 532 l — — FDA listed —
Antiseptic Hand Cleaner 10.11 g/L 64009-0336-85 Spartan 3.79 l — — FDA listed —
Clean Xpress Antiseptic Hand Cleaner 10 mg/mLthis 64009-0338-02 Spartan 1000 ml — — FDA listed —
Soft Care Defend Foam Antibacterial Handwash 1 g/100mL 64536-8308-02 Diversey, 1200 ml — — Discontinued —
Soft Care Defend Antibacterial Handwash 1 g/100mL 64536-8748-02 Diversey, 1200 ml — — Discontinued —
Soft Care Defend Antibacterial Handwash 10 g/L 64536-8760-02 Diversey, 3.78 l — — FDA listed —
WhiskCare 365 10 mg/mL 65585-0365-02 Whisk 3785 ml — — FDA listed —
AFCO 5508 Sanifect Foam-E II 2081980 mg/208198mL 66949-0139-01 Zep 208198 ml — — FDA listed —
AFCO 5508 Sanifect Foam-E II 2081980 mg/208198mL 66949-0141-01 Zep 208198 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

🏛️
2020
On the market since
Apr 2020
📍
2026
Currently FDA-listed
6 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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII I29I2VHG38
    A foaming and thickening agent derived from lauric acid (a natural fatty acid). It helps create texture and stability in liquid or semi-solid formulations, often used in topical products.
  • UNII 0L414VCS5Y
    A synthetic polymer used as a film-former and conditioning agent. It helps create a protective coating on hair or skin surfaces and improves texture and manageability in topical formulations.
  • UNII O9W3D3YF5U
    A synthetic surfactant derived from petroleum-based olefins. It helps dissolve or suspend active ingredients and other substances in liquid formulations, improving how the medicine mixes and flows.
  • 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 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, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene/Acrylates Copolymer, Tetrasodium EDTA, Citric Acid

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

LabelerSpartan Chemical Company, Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code64009
First marketedApr 2020
Product typeHuman Otc Drug
Portfolio7 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.

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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 7 words ▾

Use Reduces amount of bacteria on hands.

⏱️ Dosage and Administration 28 words ▾

Directions Wet hands and forearms. Apply a small amount (5 mL) or palmful to hands and forearms. Scrub thoroughly for at least 15 seconds. Rinse completely and dry.

⚠️ Warnings 44 words ▾

Warnings For external use only. Do not use in eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor. Not for use on children under six months of age. For institutional and professional use only.

🧪 Active Ingredient 5 words ▾

Active Ingredient Chloroxylenol 1% w/w

🧪 Inactive Ingredients 22 words ▾

Inactive Ingredients Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene/Acrylates Copolymer, Tetrasodium EDTA, Citric Acid

🎯 Purpose 3 words ▾

Purpose Skin antimicrobial

📄 Questions or Comments 2 words ▾

Questions? 1-800-537-8990

📄 Package Label / Principal Display Panel 3 words ▾

Package Label cleanxpressantiseptic2024.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Clean Xpress Antiseptic Hand Cleaner (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.

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 Spartan Chemical Company, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Spartan Chemical Company, 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.
← 64009-0336-85 · Spartan 64009-0660-02 · Spartan →
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.