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X3 Clean BENZALKONIUM CHLORIDE 1.3 mg/mL Aerosol, Foam, 75 mL — NDC 26550-0001-12 package photo

X3 Clean BENZALKONIUM CHLORIDE 1.3 mg/mL Aerosol, Foam, 75 mL

by X3 Labs Inc. · 75 mL in 1 BOTTLE (26550-001-12)
NDC 26550-0001-12
🏷️ FDA NDC (as labeled) 26550-001-12 billing pads the product segment with a zero
This package
Contains75 mL Pack sizes5 compare ↓
Also comes in: 250 ml 26550-0001-14 1000 ml 26550-0001-16 1000 ml 26550-0001-18 4000 ml 26550-0001-20
OTC On market Non-controlled
🗂️ 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 →

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-0360-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 26550-001-12
Product NDC 26550-001
11-digit billing NDC 26550000112
RxCUI 1020365
UNII F5UM2KM3W7
UPC 0814081000046
Application # M003
SPL Set ID a8eedcfd-3b97-497a-9a34-d59b0dd78439
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-09-01
Route TOPICAL
Dosage form AEROSOL, FOAM
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 26550-001-12 — 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 → 26550-0001-12. 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.

🏭 Manufacturer & labeler

LabelerX3 Labs Inc.
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code26550
First marketedSep 2009
Product typeHuman Otc Drug
Portfolio2 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?

X3 Clean is a topical foam aerosol containing benzalkonium chloride 1.3 mg/mL. Benzalkonium chloride is an antimicrobial agent commonly used in over-the-counter skin cleansing and antiseptic products. This is an OTC monograph drug, meaning it is marketed under FDA's established rules for this category of antimicrobial products 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.

🧪 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 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 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 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.

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

The official label also statesInactive Ingredients Purified Water, Glycerin, Cocamidopropyl Betaine.

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 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: 250 ml 1000 ml 1000 ml 4000 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
Instant Foam Non-alcohol PURE Hand Sanitizer .13 g/100mL 11084-0300-01 SC 47 ml — — Discontinued —
Foaming Hand 1.3 mg/mL 11344-0224-04 Nice-Pak 750 ml — — Discontinued —
Benzalkonium chloride 1.3 mg/mL 11673-0681-23 Target 68 ml — — FDA listed —
QS Plus Instant Hand Sanitizer 1.3 mg/mL 13302-0457-10 Romaine 1000 ml — — Discontinued —
X3 Clean 1.3 mg/mLthis 26550-0001-12 X3 75 ml — — FDA listed —
Tork Hand Sanitizer Alcohol Free Foam .13 g/100mL 49351-0103-01 Essity 6 bottles — — FDA listed —
Tork Hand Sanitizing Alcohol-Free Foam 1.3 mg/mL 49351-0303-01 Essity 1000 ml — — FDA listed —
X3 Clean Foaming Hand Sanitizer 1.3 mg/mL 49354-0055-75 HK 75 ml — — FDA listed —
Ben E. Keith FIHS 1.3 mg/mL 50980-0207-12 Ben 1000 ml — — FDA listed —
American Red Cross Antiseptic Cleansing Foam .13 g/100mL 51628-4539-01 MY 177 ml — — FDA listed —
North Woods Derma Foam Hand Sanitizer 1.3 mg/mL 53125-0700-54 Superior 1000 ml — — Discontinued —
DermaCen Non-Alcohol Foaming Hand Sanitizer .13 g/100mL 62654-0141-14 Central 532 ml — — FDA listed —
Byotrol Hand Sanitizer 1.3 mg/mL 63002-0002-12 Advanced 1250 ml — — FDA listed —
Hand Sanitizer 1.3 g/mL 63002-0004-33 Advanced 9.76 ml — — FDA listed —
99 Plus Hand Sanitizer 1.3 mg/mL 63533-0457-10 Momar 1000 ml — — FDA listed —
Lite nFoamy Eucalyptus Mint Sanitizing Handwash 1.3 g/L 64009-0332-72 Spartan 532 l — — FDA listed —
Lite nFoamy E2 Sanitizing Handwash 1.3 g/L 64009-0333-95 Spartan 3.79 l — — FDA listed —
Enriched Foam Alcohol-Free Hand Sanitizer 13 mg/100mL 65321-0039-01 Rubbermaid 4 pouches — — FDA listed —
Alcohol Free Foaming Hand Sanitizer 1.3 mg/mL 65601-0700-04 Betco 3780 ml — — FDA listed —
Band Aid Antiseptic Cleansing 1.3 mg/mL 69968-0728-01 Kenvue 68 ml — — FDA listed —
Blue Green Foam .13 g/100mL 70411-0100-07 H2Ocean, 207 ml — — FDA listed —
ElimiShield Hunt Core Body Foam for Hunters 1.3 mg/mL 71853-0010-00 Bryson 200 ml — — FDA listed —
Germ Free 24 Hand Sanitizer 1.3 mg/mL 71884-0006-01 Enviro 50 ml — — FDA listed —
Doctor Inks Hand Sanitizer 1.3 mg/mL 71884-0201-01 Enviro 58 ml — — FDA listed —
Mountain Air Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0040-08 K7 236 ml — — FDA listed —
Pine and Honey Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0041-08 K7 236 ml — — FDA listed —
Simply Lavender Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0042-08 K7 236 ml — — FDA listed —
Vanilla Coconut Scent FOAMING HAND SANITIZER 1.3 mg/mL 74177-0043-16 K7 473 ml — — FDA listed —
Foaming Hand Sanitizer 1.3 g/1000mL 75044-0280-16 American 2 bottles — — FDA listed —
American Red Cross Antiseptic Cleansing Foam .13 g/100mL 75742-0082-01 Zhejiang 177 ml — — FDA listed —
Hand Sanitizer .13 g/100mL 76370-0006-05 Tazza 1000 ml — — Discontinued —
Gentlecare Hand And Skin Sanitizer 1.3 mg/mL 78181-0020-02 PARAGON 50 ml — — FDA listed —
KleenLine Essentials Alcohol Free Foaming Hand Sanitizer 1.3 mg/mL 79258-0700-29 Brady 1000 ml — — FDA listed —
Hygiene Clean Balsam Fir Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0004-01 USA 237 ml — — FDA listed —
Hygiene Clean Leather Oak Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0005-01 USA 237 ml — — FDA listed —
Hygiene Clean Mahogany Teakwood Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0006-01 USA 237 ml — — FDA listed —
Hygiene Clean Pumpkin Spice Hand Sanitizer Alcohol Free 1.3 mg/mL 80499-0007-01 USA 237 ml — — FDA listed —
Hygiene Clean Spring Bloom Hand Sanitizer Bottle Alcohol Free 1.3 mg/mL 80499-0025-08 USA 237 ml — — FDA listed —
Hygiene Clean Lilac Garden Hand Sanitizer Bottle Alcohol Free 1.3 mg/mL 80499-0026-08 USA 237 ml — — FDA listed —
Hygiene Clean Lavender Blossom Hand Sanitizer Bottle Alcohol Free 1.3 mg/mL 80499-0027-08 USA 237 ml — — FDA listed —
Hygiene Clean Clean Cotton Hand Sanitizer 1.3 mg/mL 80499-0100-01 USA 800 ml — — FDA listed —
Hygiene Clean Eucalyptus Hand Sanitizer 1.3 mg/mL 80499-0101-01 USA 800 ml — — FDA listed —
Hygiene Clean Luxury Clean Hand Sanitizer 1.3 mg/mL 80499-0102-01 USA 800 ml — — FDA listed —
Antiseptic Foaming Hand Sanitizer 1.3 mg/mL 82442-0812-20 Target 2 bottles — — FDA listed —
NOxyDERM .13 g/100mL 83823-0001-01 NOxy 100 ml — — FDA listed —
NOxyDERM .038 g/29.5mL 83823-0002-01 NOxy 29.5 ml — — FDA listed —
Foaming Hand Sanitizer 1.3 mg/mL 83986-0118-45 UpLift 1150 ml — — FDA listed —
Guardelle .13 g/100mL 85754-0000-02 Social 52 ml — — FDA listed —
GrowDefender Antibacterial Foam 1.3 mg/mL 87109-0013-01 Grow 50.68 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

🏛️
2009
On the market since
Sep 2009
📍
2026
Currently FDA-listed
17 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
26550-0001-12 You're viewing this 75 mL in 1 BOTTLE (26550-001-12) 2009-09-01 Active
26550-0001-14 250 mL in 1 BOTTLE (26550-001-14) 2009-09-01 Active
26550-0001-16 1000 mL in 1 BOTTLE (26550-001-16) 2009-09-01 Active
26550-0001-18 1000 mL in 1 CARTRIDGE (26550-001-18) 2009-09-01 Active
26550-0001-20 4000 mL in 1 BOTTLE (26550-001-20) 2009-09-01 Active

Pack size FAQ

What quantity is in NDC 26550-0001-12?
NDC 26550-0001-12 contains 75 mL — 75 ml in 1 bottle.
What is the difference between NDC 26550-0001-12 and NDC 26550-0001-14?
Both are X3 Clean BENZALKONIUM CHLORIDE 1.3 mg/mL Aerosol, Foam — the drug itself is identical. NDC 26550-0001-12 is the 75 mL package, while NDC 26550-0001-14 is the 250 ml package.
What NDC number is used to bill for this package of X3 Clean BENZALKONIUM CHLORIDE 1.3 mg/mL Aerosol, Foam?
Bill NDC 26550-0001-12 — the 11-digit billing format is 26550000112. 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 26550-001-12, 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: 26550-0001-12, written without dashes as 26550000112. 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 26550-0001-12, the first segment (26550) is the labeler code FDA assigned to X3 Labs Inc.; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) 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 X3 Labs Inc.. 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 4 other package presentations of this same product, including 250 ml (26550-0001-14), 1000 ml (26550-0001-16), 1000 ml (26550-0001-18). 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?
X3 Labs 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.

📄 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 and Cautions ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 11 words ▾

Use To decrease bacteria on the skin that could cause disease.

⏱️ Dosage and Administration 14 words ▾

Directions Apply a small amount to palms and rub hands thoroughly until completely dry.

⚠️ Warnings and Cautions 5 words ▾

Other Information Do not freeze.

⚠️ Warnings 22 words ▾

Warnings For external use only. Do not use in or near eyes. In case of contact with eyes, flush thoroughly with water.

🧪 Active Ingredient 5 words ▾

Active Ingredient Benzalkonium Chloride 0.13%

🧪 Inactive Ingredients 7 words ▾

Inactive Ingredients Purified Water, Glycerin, Cocamidopropyl Betaine.

🎯 Purpose 2 words ▾

Purpose Antimicrobial

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 26251-0005-01 · Tianjin 26550-0002-10 · X3 →
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.