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ZylastXP Antiseptic Foaming Benzethonium Chloride 2 mg/mL Soap, 244 mL — NDC 57362-467-01 (Billing 57362-0467-01)

by Innovative Biodefense · 244 mL in 1 BOTTLE

This is a package of 244 mL of ZylastXP Antiseptic Foaming Benzethonium Chloride 2 mg/mL Soap from Innovative Biodefense, marketed since Apr 2015 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 57362-0467-01
🏷️ FDA NDC (as labeled) 57362-467-01 billing pads the product segment with a zero
This package
Contains244 mL Pack sizes2 compare ↓
Main listing for product 57362-467 · Also comes in: 1000 ml 57362-467-02
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) 57362-467-01
Product NDC 57362-467
11-digit billing NDC 57362046701
RxCUI 1243889
UNII PH41D05744
UPC 0094922487056, 0094922464156
Application # 505G(a)(3)
SPL Set ID 86857d95-56ce-2eb4-e053-2a91aa0ad557
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-04-06
Route TOPICAL
Dosage form SOAP
Substance BENZETHONIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1243889
Why two NDCs? The FDA registers this code as 57362-467-01 — 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 → 57362-0467-01. 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 Antiseptics class.

Drug family (ATC) Antiseptics, Quaternary ammonium compounds
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?

ZylastXP is a topical antiseptic soap containing benzethonium chloride, an active ingredient typically used to reduce bacteria on the skin. This foaming cleanser is marketed as an over-the-counter monograph drug, meaning it follows FDA guidelines for antiseptic soaps in this category. Benzethonium chloride functions as a broad-spectrum antimicrobial agent commonly found in hand soaps and cleansing products intended for routine hygiene and minor wound care.

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: 1000 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
57362-0467-01 You're viewing this Main listing 244 mL in 1 BOTTLE 2015-04-13 — Active
57362-0467-02 57362-467-02 1000 mL in 1 BOTTLE 2015-04-13 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 244 mL — 244 ml in 1 bottle.
How does this package differ from NDC 57362-0467-02?
Both are ZylastXP Antiseptic Foaming Benzethonium Chloride 2 mg/mL Soap — the drug itself is identical. This page's package is the 244 mL one, while NDC 57362-0467-02 is the 1000 ml package.
What NDC number is used to bill for this package of ZylastXP Antiseptic Foaming Benzethonium Chloride 2 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
benzethonium chloride liquid .2 g/100g 37945-0902-08 Bio-Medical 236 g — — FDA listed —
ZylastXP Antiseptic Foaming 2 mg/mLthis 57362-0467-01 Innovative 244 ml — — FDA listed —
A-Cute Derm B-Kleer 2 mg/mL 68605-1040-02 ABBE 946.35 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
Apr 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 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII UC9PE95IBP
    A synthetic compound that works as a preservative and antimicrobial agent in medicines. It helps prevent bacterial and fungal growth, extending the shelf life of liquid formulations like eye drops and topical solutions.
  • 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 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 EB41QIU6JL
    Farnesol is a natural fragrant compound found in plants. It's used in medicines as a preservative and flavoring agent to improve taste and help prevent microbial growth.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 4F6FC4MI8W
    Lauramine oxide is a surfactant, a substance that helps mix oil and water together. It's used in medicines to improve how ingredients blend and to help the product dissolve or spread properly.
  • UNII DEL7T5QRPN
    A synthetic preservative that kills bacteria and fungi. It's added to medications to prevent microbial growth and extend shelf life, especially in liquid or topical formulations.
  • UNII 322U039GMF
    Polihexanide is a synthetic antimicrobial chemical used as a preservative in some liquid medications and topical products. It prevents bacterial and fungal growth to maintain product safety during storage and use.
  • UNII 34N07GUJ3X
    A synthetic conditioning agent derived from coconut oil. It functions as an emulsifier and thickener, helping blend water and oil-based ingredients together and improving the texture and feel of the formulation.
  • 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.
  • UNII U6WSN5SQ1Z
    Zinc gluconate is a form of zinc, a mineral, combined with gluconic acid. It's used as a supplement ingredient to provide zinc content in the formulation.

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

The official label also statesAlcohol Denatured, Aloe Barbadenis Lead Extract, Butylene Glycol, Cetrimonium Chloride, Citric Acid, Cocamidopropyl Betaiine, Farnesol, Fragrance, Glycerin, Lauramine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, Polyaminopropyl Biguanide, Polyquaternium-10, PPG-12 Hydroxyethyl Cocamide, Water, Zinc Gluconate

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

LabelerInnovative Biodefense
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code57362
First marketedApr 2015
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 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

Uses Handwash to decrease bacteria on the skin. Recommended for repeated use.

⏱️ Dosage and Administration 30 words ▾

Directions Wet hands and forearms. Apply one pump to hands and forearms thoroughly for 15 seconds or more. Rinse and repeat. For children under 6, use only with adult supervision.

⚠️ Warnings 35 words ▾

Warnings For external use only. When using this product, do not use in or near eyes. In case of contact, rinse eyes throroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

🧪 Active Ingredient 6 words ▾

Active Ingredients Benzethonium Chloride - 0.20%

🧪 Inactive Ingredients 32 words ▾

Inactive ingredients Alcohol Denatured, Aloe Barbadenis Lead Extract, Butylene Glycol, Cetrimonium Chloride, Citric Acid, Cocamidopropyl Betaiine, Farnesol, Fragrance, Glycerin, Lauramine Oxide, Methylchloroisothiazolinone, Methylisothiazolinone, Polyaminopropyl Biguanide, Polyquaternium-10, PPG-12 Hydroxyethyl Cocamide, Water, Zinc Gluconate

🎯 Purpose 2 words ▾

Purpose Antiseptic

📄 Stop Use and Ask a Doctor If 18 words ▾

Stop use and ask a doctor if Irritation or redness develops. Condition persists for more than 72 hours.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Recent Major Changes 9 words ▾

Uses section Warnings section Inactive Ingredients section Directions section

📄 Package Label / Principal Display Panel 37 words ▾

Package/Label Principal Display Panel NDC 57362-467-01 Zylast Extended Protection Broad Spectrum Antimicrobial Antiseptic Foaming Soap 8.25 oz 8.25 oz

Package/Label Principal Display Panel NDC 57362-467-02 Zylast Extended Protection Broad Spectrum Antimicrobial Antiseptic Foaming Soap 1000mL (33.8oz) 1000mL

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 — Not published for this NDC No photo available yet for this listing.
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 Innovative Biodefense. 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 1000 ml (57362-0467-02). 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?
Innovative Biodefense 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.
← 57362-0466-16 · Innovative 57362-0468-00 · Innovative →
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.