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Zylast Antiseptic K Benzalkonium Chloride .13 g/100mL Lotion, 59.1 mL — NDC 57362-0468-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Zylast Antiseptic K Benzalkonium Chloride .13 g/100mL Lotion, 59.1 mL — NDC 57362-468-00 (Billing 57362-0468-00)

by Innovative Biodefense · 59.1 mL in 1 BOTTLE, DISPENSING

This is a package of 59.1 mL of Zylast Antiseptic K Benzalkonium Chloride .13 g/100mL Lotion from Innovative Biodefense, marketed since Jan 2020 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 57362-0468-00
🏷️ FDA NDC (as labeled) 57362-468-00 billing pads the product segment with a zero
This package
Contains59.1 mL Pack sizes4 compare ↓
Main listing for product 57362-468 · Also comes in: 14.8 ml 57362-468-04 236.6 ml 57362-468-03 1000 ml 57362-468-05
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

⚠️
Other active recalls for Benzalkonium Chloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 8, 2026 — CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0693-2026
Class II · Apr 8, 2026 — CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0699-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0375-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0369-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0365-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0374-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 57362-468-00
Product NDC 57362-468
11-digit billing NDC 57362046800
RxCUI 1046442
UNII F5UM2KM3W7
UPC 0040232338182, 0040232338168, 0040232338151
Application # 505G(a)(3)
SPL Set ID 84766b3b-915c-b604-e053-2a91aa0a672c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-01-01
Route TOPICAL
Dosage form LOTION
Substance BENZALKONIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1046442
Why two NDCs? The FDA registers this code as 57362-468-00 — 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 → 57362-0468-00. 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 Quaternary ammonium compounds class.

Drug family (ATC) Quaternary ammonium compounds, Medicated dressings with antiinfectives, Antiseptics
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?

Zylast Antiseptic K is an over-the-counter topical lotion containing benzalkonium chloride, a quaternary ammonium compound. Benzalkonium chloride is typically used as an antimicrobial and antiseptic agent in skin care products. This lotion is formulated as an OTC monograph drug, meaning it is marketed under FDA's established regulations for antiseptic lotions rather than as an individually approved application.

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 gPer 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: 14.8 ml 236.6 ml 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
57362-0468-00 You're viewing this Main listing 59.1 mL in 1 BOTTLE, DISPENSING 2020-01-01 — Active
57362-0468-03 57362-468-03 236.6 mL in 1 BOTTLE, PUMP 2020-01-01 — Active
57362-0468-04 57362-468-04 14.8 mL in 1 TUBE 2020-01-01 — Active
57362-0468-05 57362-468-05 1000 mL in 1 CARTRIDGE 2020-01-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 59.1 mL — 59.1 ml in 1 bottle, dispensing.
How does this package differ from NDC 57362-0468-04?
Both are Zylast Antiseptic K Benzalkonium Chloride .13 g/100mL Lotion — the drug itself is identical. This page's package is the 59.1 mL one, while NDC 57362-0468-04 is the 14.8 ml package.
What NDC number is used to bill for this package of Zylast Antiseptic K Benzalkonium Chloride .13 g/100mL Lotion?
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
Target Up and Up 2-in-1 Hand Sanitizer 1.3 mg/mL 11673-0147-15 TARGET 150 ml — — FDA listed —
Zylast Antiseptic K .13 g/100mLthis 57362-0468-00 Innovative 59.1 ml — — FDA listed —
I.C. Waterless Hand Cleaner with Micro Scrubbers 1.3 mg/mL 59555-0303-04 R 59 ml — — FDA listed —
I.C. Sanitizer and Re-Moisturizer with Benzalkonium Chloride 1.3 mg/mL 59555-0903-03 R 50 ml — — FDA listed —
Vaseline 1.3 mg/mL 64942-1849-01 Conopco 88.5 ml — — FDA listed —
Dr Lift Antibacterial .156 mg/120mg 68062-2243-01 Spa 120 mg — — FDA listed —
Dermadive Ultracare - Tetraid .13 g/100mL 78663-0102-34 Releaf 100 ml — — FDA listed —
Tazza Antiseptic Hand Sanitizing Wipes .13 g/100mL 76370-0018-00 Tazza 320 applicators — — Discontinued —
Tazza King Wipes .13 g/100mL 76370-0024-00 Tazza 950 applicators — — Discontinued —
Moxie Hand Wipes .13 g/100mL 77720-0035-01 Skaffles 1 ml — — FDA listed —
Meijer Antibacterial Amber Hand .13 g/100mL 79481-0156-01 Meijer, 1650 ml — — FDA listed —
XTRA Squeeze Antibacterial Hand Juicy Orange .13 g/100mL 84987-0002-01 Zhejiang 458 ml — — FDA listed —
XTRA Squeeze Antibacterial Hand Fresh Lemon .13 g/100mL 84987-0003-01 Zhejiang 458 ml — — FDA listed —
XTRA Squeeze Antibacterial Hand Fresh Lemon .13 g/100mL 51628-4502-01 MY 458 ml — — FDA listed —
Marvel Bzk Antiseptic Wipe .13 g/100mL 70108-0104-01 Ashtel 1 pouch — — FDA listed —
Pharma-Care Skin Preparation Cloths .13 g/100mL 71884-0015-02 Enviro 1 packet — — FDA listed —
Black Ops Ab Antibacterial Foaming .13 g/100mL 79016-0103-12 Archer 1000 ml — — FDA listed —
XTRA Antibacterial Hand Fresh Lemon .13 g/100mL 84987-0004-01 Zhejiang 399 ml — — FDA listed —
Sanitaxe Antibacterial .13 g/100mL 72197-0033-27 American 800 ml — — FDA listed —
Tazza .13 g/100mL 76370-0009-00 Tazza 500 applicators — — Discontinued —
XTRA Squeeze Antibacterial Hand Juicy Orange .13 g/100mL 51628-4442-01 MY 458 ml — — FDA listed —
Meijer Antibacterial Spring Rain Hand .13 g/100mL 79481-0125-01 Meijer, 1650 ml — — FDA listed —
Club Wipes Usa Sanitizing Wipes .13 g/100mL 80976-0102-01 Bubble 3.15 ml — — FDA listed —
Nurture ANTISEPTIC WIPES .13 g/100mL 81072-0001-01 Devon 1 packet — — FDA listed —
Proheal Benzalkonium Chloride Antiseptic Towelettes .13 g/100mL 86173-0006-12 Click 120 pouches — — FDA listed —
My-Shield Hand Sanitizer Gel .13 g/100mL 71884-0011-01 Enviro 3 tubes — — Discontinued —
Wipes4Health .13 g/100mL 80976-0100-01 Bubble 3.15 ml — — FDA listed —
XTRA Antibacterial Hand Fresh Lemon .13 g/100mL 51628-4503-01 MY 399 ml — — FDA listed —
Tazza .13 g/100mL 76370-0013-00 Tazza 1700 applicators — — Discontinued —
Tazza Optima Sanitizing Wipes .13 g/100mL 76370-0023-01 Tazza 1460 applicators — — Discontinued —
Tork Foam Antibacterial .13 g/100mL 49351-0104-01 Essity 1000 ml — — FDA listed —
Tazza Hand Sanitizer Gym Wipes .13 g/100mL 76370-0017-00 Tazza 1500 applicators — — FDA listed —
Meijer Antibacterial White Tea and Berry Hand .13 g/100mL 79481-0135-01 Meijer, 221 ml — — FDA listed —
Tazza .13 g/100mL 76370-0001-00 Tazza 180 applicators — — FDA listed —
Tazza Antiseptic Hand Sanitizing Wipes .13 g/100mL 76370-0016-00 Tazza 1400 applicators — — FDA listed —
Tazza Antiseptic Hand Sanitizing Wipes .13 g/100mL 76370-0019-00 Tazza 250 applicators — — Discontinued —
Tazza XL Wipes .13 g/100mL 76370-0025-02 Tazza 1500 applicators — — Discontinued —
RHINO Hand Sanitizing Wipes .13 g/100mL 76370-0026-00 Tazza 1500 applicators — — Discontinued —
Complete .13 g/100mL 63900-0101-02 Simoniz 4 bottles — — FDA listed —
Saniclean .13 g/100mL 63900-0110-02 Simoniz 4 bottles — — FDA listed —
Barbie BZK ANTISEPTIC WIPE .13 g/100mL 70108-0107-01 Ashtel 1 pouch — — 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
Jan 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 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.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesWater, Alcohol Denature, Cetearyl Alcohol, Glycerin,Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin, Dimethicone, Stearamidopropyl Dimethylamine, Benzyl Alcohol, Farnesol, Panthenol, Zinc Gluconate, Chlorhexidine Digluconate, Citric Acid, Polyquaternium-10, Tocopheryl Acetate.

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 marketedJan 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 📦 Storage and Handling 🧪 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 10 words ▾

Uses To decrease bacteria on skin. Recommended for repeated use.

⏱️ Dosage and Administration 21 words ▾

Directions Wet hands thoroughly with product and allow to dry without wiping. 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 thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

📦 Storage and Handling 6 words ▾

Other Information Store at 20-25°C (68-77°F)

🧪 Active Ingredient 5 words ▾

Active Ingredient Benzalkonium Chloride- 0.13%

🧪 Inactive Ingredients 27 words ▾

Inactive Ingredient Water, Alcohol Denature, Cetearyl Alcohol, Glycerin,Phenoxyethanol Caprylyl Glycol Ethylhexylglycerin, Dimethicone, Stearamidopropyl Dimethylamine, Benzyl Alcohol, Farnesol, Panthenol, Zinc Gluconate, Chlorhexidine Digluconate, Citric Acid, Polyquaternium-10, Tocopheryl Acetate.

🎯 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 28 words ▾

Uses section Warnings section Stop and ask a doctor if section Keep out of reach of children section Directions section Inactive Ingredient section Package Label. Principal Display Panel

📄 Package Label / Principal Display Panel 62 words ▾

NDC 57362-468-04 Zylast Broad Sprectrum Antimicrobial Antiseptic 14.79 mL (0.5 fl. oz) NDC 57362-468-00 Zylast Broad Sprectrum Antimicrobial Antiseptic 59.159 mL (2 fl. oz) NDC 57362-468-03 Zylast Broad Sprectrum Antimicrobial 236.59 mL (8 fl. oz) NDC 57362-468-05 Zylast Broad Sprectrum Antimicrobial Antiseptic 1000 mL (33.8 fl. oz)

0.5 Lotion K 2 oz Lotion K 8 oz Lotion K 1000 mL lotion K

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 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 3 other package presentations of this same product, including 14.8 ml (57362-0468-04), 236.6 ml (57362-0468-03), 1000 ml (57362-0468-05). 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?
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.
← 57362-0467-01 · Innovative 57362-0469-18 · Westwood →
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.