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

by HK Kolmar Canada, Inc · 75 mL in 1 BOTTLE, PUMP (49354-055-75)
NDC 49354-0055-75
🏷️ FDA NDC (as labeled) 49354-055-75 billing pads the product segment with a zero
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) 49354-055-75
Product NDC 49354-055
11-digit billing NDC 49354005575
RxCUI 1020365
UNII F5UM2KM3W7
UPC 0814081000022
Application # 505G(a)(3)
SPL Set ID 3c636145-03fe-47c7-81fc-279fef69b1c3
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-05-01
Route TOPICAL
Dosage form AEROSOL, FOAM
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 49354-055-75 — 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 → 49354-0055-75. 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

LabelerHK Kolmar Canada, Inc
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code49354
First marketedMay 2019
Product typeHuman Otc Drug
Portfolio37 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 Foaming Hand Sanitizer is a foaming aerosol spray applied to the skin. It contains benzalkonium chloride, an antimicrobial agent that is typically used in over-the-counter hand sanitizers to help reduce bacteria on the hands. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for hand sanitizer products rather than being individually reviewed and approved.

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 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.
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/mL 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/mLthis 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

🏛️
2019
On the market since
May 2019
📍
2026
Currently FDA-listed
7 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 X3 Clean Foaming Hand Sanitizer (this brand).

Top reported reactions

Drug Hypersensitivity118
Condition Aggravated114
Arthralgia112
Musculoskeletal Stiffness111
Pain In Extremity111
Infection110
Hepatotoxicity108

Age at onset

Infant1
Adolescent3
Adult36
Elderly10

Reporter sex

331 reports
Male · 28%
Female · 72%
Unknown · 0%

Serious outcomes

Hospitalization175
Life-threatening27
Disabling18
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 77 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
49354-0055-75 You're viewing this 75 mL in 1 BOTTLE, PUMP (49354-055-75) 2019-05-01 Active

🧭 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) — 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.
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 49354-055-75, 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: 49354-0055-75, written without dashes as 49354005575. 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 49354-0055-75, the first segment (49354) is the labeler code FDA assigned to HK Kolmar Canada, Inc; the middle segment (0055) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (75) 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 HK Kolmar Canada, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
HK Kolmar Canada, 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 🧪 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 50 words ▾

Warnings For external use only. Do not use in or near the eyes. In case of contact with eyes, flush thoroughly with water. Stop use and ask doctor if skin irritation develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

🧪 Active Ingredient 7 words ▾

Active ingredient Benzalkonium Chloride 0.13% Purpose Antimicrobial

🧪 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 ↗
← 49354-0053-00 · HK 49354-0060-00 · HK →
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.