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pre fense BENZALKONIUM CHLORIDE 120 mg/100mL Liquid, 1000 mL

by Prefense LLC · 1000 mL in 1 POUCH (48404-051-03)
NDC 48404-0051-03
🏷️ FDA NDC (as labeled) 48404-051-03 billing pads the product segment with a zero
This package
Contains1000 mL Pack sizes6 compare ↓
Also comes in: 3 bottles 48404-0051-06 6 bottles 48404-0051-05 44.4 ml 48404-0051-01 237 ml 48404-0051-02 1893 ml 48404-0051-04
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) 48404-051-03
Product NDC 48404-051
11-digit billing NDC 48404005103
RxCUI 1052949
UNII F5UM2KM3W7
Application # 505G(a)(3)
SPL Set ID fad70060-8bb6-4b06-a353-666132f64c26
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-05-11
Route TOPICAL
Dosage form LIQUID
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 48404-051-03 — 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 → 48404-0051-03. 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

LabelerPrefense LLC
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code48404
First marketedMay 2020
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?

Pre Fense Benzalkonium Chloride is a topical liquid antiseptic marketed as an over-the-counter monograph product. Benzalkonium chloride is a antimicrobial agent typically used to reduce bacteria and other microorganisms on the skin surface. This type of product is commonly applied to skin for cleansing and disinfection purposes in first-aid or hygiene settings.

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 T21BNL1S7F
    A silane compound used as a surface modifier and coupling agent in pharmaceutical manufacturing. It helps improve how active ingredients bind to tablet materials and enhances the stability of the finished product during storage.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 IQ36O85WQ4
    A silicone-based surface-active compound used as a glidant and anti-caking agent. It reduces friction between particles and tablet surfaces, improving powder flow during manufacturing and tablet handling.
  • UNII UP0M8M3VZW
    A fragrant essential oil extracted from lemongrass plants, used primarily as a flavoring and fragrance agent to improve taste and aroma in oral medications.
  • UNII VR5Y7PDT5W
    A saltwater solution with the same concentration as blood. It's used as a vehicle or diluent in injectable medicines to help distribute the active drug and maintain proper fluid balance in the body.
  • UNII Y4S76JWI15
    Methyl alcohol, also called methanol, is a simple organic solvent. It helps dissolve and carry active ingredients in liquid medicines, and helps the product mix evenly.
  • UNII AKN3KSD11B
    Orange oil obtained by cold pressing orange peel. It serves as a flavoring agent and fragrance in medicines to improve taste and aroma.
  • 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.

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

The official label also states3-Chloropropyltrimethoxysilane, Acetic Acid, Anhydrous Citric Acid, Cocomidoprophyl betaine, Octadecyldimethyl (3-trimethoxysilylpropyl)ammonium chloride, East Indian Lemongrass Oil, Isotonic Sodium Chloride Solution, Orange Oil, Water

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 mLPer 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: 3 bottles 6 bottles 44.4 ml 237 ml 1893 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
pre fense unscented 120 mg/100mL 48404-0050-01 Prefense 44.4 ml — — FDA listed —
pre fense 120 mg/100mLthis 48404-0051-03 Prefense 1000 ml — — FDA listed —
Hygienic Ear Care Antiseptic 1.2 mg/mL 70094-0001-04 The 118 ml — — FDA listed —
Inverness Home Ear Piercing Kit 70094-0004-03 The 1 kit — — FDA listed —
Inverness Hygienic Ear Care Antiseptic 1.2 mg/mL 70094-0005-01 The 60 ml — — FDA listed —
Lovisa Piercing Care Solution 1.2 mg/mL 70094-0006-01 The 60 ml — — FDA listed —
Inverness Ear Care 1.2 mg/mL 70094-0007-01 The 118 ml — — FDA listed —
Helzberg Diamonds Ear Care 1.2 mg/mL 70094-0008-01 The 60 ml — — FDA listed —
Ulta Beauty Ear Care 1.2 mg/mL 70094-0009-01 The 118 ml — — FDA listed —
Inverness EAR CARE ANTISEPTIC 1.2 mg/mL 70094-0010-02 The 60 ml — — FDA listed —
bolor sanitizing hand wipes .12 mg/100mg 77665-0002-02 Guangzhou 60 packets — — FDA listed —
bolor sanitizing hand wipes .12 mg/100mg 85577-0002-02 EcoRhine 60 packets — — 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
May 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.

🔬 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 BENZALKONIUM CHLORIDE — the ingredient across all brands.

Top reported reactions

Drug Hypersensitivity124
Arthralgia117
Condition Aggravated115
Pain In Extremity114
Infection111
Musculoskeletal Stiffness111
Joint Swelling109

Age at onset

Infant1
Child1
Adolescent3
Adult41
Elderly17

Reporter sex

479 reports
Male · 32%
Female · 68%
Unknown · 0%

Serious outcomes

Hospitalization211
Life-threatening33
Death31
Disabling23
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 40 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
48404-0051-01 44.4 mL in 1 BOTTLE (48404-051-01) 2020-05-11 Active
48404-0051-02 237 mL in 1 BOTTLE (48404-051-02) 2020-05-11 Active
48404-0051-03 You're viewing this 1000 mL in 1 POUCH (48404-051-03) 2020-05-11 Active
48404-0051-04 1893 mL in 1 JUG (48404-051-04) 2020-05-11 Active
48404-0051-05 6 BOTTLE in 1 PACKAGE (48404-051-05) / 44.4 mL in 1 BOTTLE 2020-05-11 Active
48404-0051-06 3 BOTTLE in 1 PACKAGE (48404-051-06) / 236.6 mL in 1 BOTTLE 2020-05-11 Active

Pack size FAQ

What quantity is in NDC 48404-0051-03?
NDC 48404-0051-03 contains 1000 mL — 1000 ml in 1 pouch.
What is the difference between NDC 48404-0051-03 and NDC 48404-0051-06?
Both are pre fense BENZALKONIUM CHLORIDE 120 mg/100mL Liquid — the drug itself is identical. NDC 48404-0051-03 is the 1000 mL package, while NDC 48404-0051-06 is the 3 bottles package.
What NDC number is used to bill for this package of pre fense BENZALKONIUM CHLORIDE 120 mg/100mL Liquid?
Bill NDC 48404-0051-03 — the 11-digit billing format is 48404005103. 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 — 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 FDA registers it as 48404-051-03, 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: 48404-0051-03, written without dashes as 48404005103. 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 48404-0051-03, the first segment (48404) is the labeler code FDA assigned to Prefense LLC; the middle segment (0051) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Prefense LLC. 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 5 other package presentations of this same product, including 3 bottles (48404-0051-06), 6 bottles (48404-0051-05), 44.4 ml (48404-0051-01). 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?
Prefense LLC 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 ▾

Uses: Hand sanitizer to help reduce germs that potentially cause disease.

⏱️ Dosage and Administration 10 words ▾

Directions: Apply to dry hands, rub together, and let dry.

⚠️ Warnings 24 words ▾

Warning: For external use only. Avoid contact with eyes. In case of eye contact, flush with water. Discontinue use if irritation or redness occurs.

🧪 Active Ingredient 9 words ▾

Active Ingredient Drug Facts Active Ingredient Benzalkonium Chloride ............0.12%

🧪 Inactive Ingredients 24 words ▾

Inactive Ingredients: 3-Chloropropyltrimethoxysilane, Acetic Acid, Anhydrous Citric Acid, Cocomidoprophyl betaine, Octadecyldimethyl (3-trimethoxysilylpropyl)ammonium chloride, East Indian Lemongrass Oil, Isotonic Sodium Chloride Solution, Orange Oil, Water

🎯 Purpose 5 words ▾

Purpose Hand and Skin Sanitizer

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 48404-0050-01 · Prefense 48433-0001-06 · Safecor →
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.