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Antibacterial Benzethonium Chloride .13 g/100mL Liquid, 1000 mL — NDC 68599-5501-02 package photo

Antibacterial Benzethonium Chloride .13 g/100mL Liquid, 1000 mL

by McKesson · 1000 mL in 1 BOTTLE (68599-5501-2)
NDC 68599-5501-02
🏷️ FDA NDC (as labeled) 68599-5501-2 billing pads the package segment with a zero
This package
Contains1000 mL Pack sizes4 compare ↓
Also comes in: 237 ml 68599-5501-03 532 ml 68599-5501-04 3785 ml 68599-5501-01
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

🆔 Identity & classification

FDA NDC (as labeled) 68599-5501-2
Product NDC 68599-5501
11-digit billing NDC 68599550102
RxCUI 1039026
UNII PH41D05744
UPC 0612479227002
Application # M003
SPL Set ID 58892abf-e0b9-83d9-e053-2a91aa0ad035
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-09-29
Route TOPICAL
Dosage form LIQUID
Substance BENZETHONIUM CHLORIDE
GCN Seq No 053936
GCN 21725
HICL code 004259
Ingredient (HICL) Benzethonium Chloride
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5B
Therapeutic class — specific (HIC3) Topical Preparations,Antibacterials
AHFS code 84:04.92.00
AHFS class Local Anti-Infectives, Miscellaneous
FDB label name ANTIBACTERIAL 0.13% SOAP RFL
FDB brand name Antibacterial Soap
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 68599-5501-2 — a 5-4-1 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 package segment → 68599-5501-02. 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.

🏭 Manufacturer & labeler

LabelerMcKesson
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code68599
First marketedSep 2017
Product typeHuman Otc Drug
Portfolio27 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

Label name ANTIBACTERIAL 0.13% SOAP RFL Ingredient Benzethonium Chloride
🧪 What is this product?

This is a topical liquid antibacterial product containing benzethonium chloride, an antimicrobial agent typically used in over-the-counter skin cleansing and antiseptic applications. Benzethonium chloride is commonly found in products meant to help reduce bacteria on the skin surface. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and use guidelines for this category of antimicrobial products rather than being reviewed as a new drug application.

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.

🧪 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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 M4SL82J7HK
    A foaming and cleansing agent derived from coconut oil. It's used in liquid formulations to create texture, improve spreadability, and help distribute active ingredients evenly throughout the product.
  • UNII C80684146D
    A foaming agent and thickener derived from coconut oil. It helps create a smooth texture and stable foam in liquid or semi-solid medicines, improving how the product feels and applies.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • UNII X3W0AM1JLX
    A synthetic red dye used to color medicines and products. It helps make pills, liquids, and capsules visually distinct and easier to identify.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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 Z8ROG2A0LZ
    A thick, waxy substance made by combining polyethylene glycol with stearic acid. It helps emulsify and blend oil and water-based ingredients, and improves texture and spreadability in topical and oral medicines.
  • UNII O414PZ4LPZ
    A beta hydroxy acid derived from willow bark or synthesized chemically. In topical medicines, it acts as a keratolytic agent that helps soften and shed dead skin cells, improving penetration of active ingredients.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • 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.

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

The official label also statesInactive Ingredients: Benzyl Alcohol, Cetrimonium Chloride, Citric Acid, Cocamide MEA, Cocamidopropylamine Oxide, Fragrance, Glycerin, PEG-200 Glyceryl Stearate, Red 4, Salicylic Acid, Sorbic Acid, Tetrasodium EDTA, Water, Yellow 5, (may contain Sodium Hydroxide)

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: 237 ml 532 ml 3785 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
DermaCen Antimicrobial-B Hand .13 g/100mL 62654-0232-09 Central 266 ml — — FDA listed —
Antibacterial .13 g/100mLthis 68599-5501-02 McKesson 1000 ml — — FDA listed —
Antibacterial .13 g/100mL 68599-5502-01 McKesson 251 ml — — FDA listed —
Clean Revolution Anti-Bacterial Foaming Hand Refill Supply Container - Anti-Bacterial - ELIMINATES 99.9% Germs - Ready To Use - Fresh Orange 1.3 mg/mL 74810-0727-00 Replenish 3785 ml — — FDA listed —
Clean Revolution Anti-Bacterial Hand Refill Supply Container - Anti-Bacterial - ELIMINATES 99.9% Germs - Ready To Use - Fresh Orange 1.3 mg/mL 74810-0728-00 Replenish 3785 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

🏛️
2017
On the market since
Sep 2017
📍
2026
Currently FDA-listed
9 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 Antibacterial (this brand).

Top reported reactions

Toxicity To Various Agents6,010
Completed Suicide5,432
Drug Abuse5,289
Overdose1,891
Death1,602
Intentional Overdose1,541
Cardio-respiratory Arrest1,346

Reporter sex

27,171 reports

Serious outcomes

Death15,173
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,703 1,506
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
68599-5501-01 3785 mL in 1 BOTTLE (68599-5501-1) 2017-09-29 Active
68599-5501-02 You're viewing this 1000 mL in 1 BOTTLE (68599-5501-2) 2017-09-29 Active
68599-5501-03 237 mL in 1 BOTTLE, DISPENSING (68599-5501-3) 2017-09-29 Active
68599-5501-04 532 mL in 1 BOTTLE, DISPENSING (68599-5501-4) 2017-09-29 Active

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 68599-5501-02?
NDC 68599-5501-02 contains 1000 mL — 1000 ml in 1 bottle.
What is the difference between NDC 68599-5501-02 and NDC 68599-5501-03?
Both are Antibacterial Benzethonium Chloride .13 g/100mL Liquid — the drug itself is identical. NDC 68599-5501-02 is the 1000 mL package, while NDC 68599-5501-03 is the 237 ml package.
What NDC number is used to bill for this package of Antibacterial Benzethonium Chloride .13 g/100mL Liquid?
Bill NDC 68599-5501-02 — the 11-digit billing format is 68599550102. 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 68599-5501-2, 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: 68599-5501-02, written without dashes as 68599550102. 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 68599-5501-02, the first segment (68599) is the labeler code FDA assigned to McKesson; the middle segment (5501) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 McKesson. 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 237 ml (68599-5501-03), 532 ml (68599-5501-04), 3785 ml (68599-5501-01). 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?
McKesson 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 10 words ▾

Uses • For handwashing to decrease bacteria on the skin.

⏱️ Dosage and Administration 24 words ▾

Directions • Apply to hands and wet as needed. • Lather vigorously for at least 15 seconds. • Wash skin, rinse thoroughly and dry.

⚠️ Warnings 30 words ▾

Warnings For external use only . Do not use in the eyes. Discontinue use if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

🧪 Active Ingredient 6 words ▾

Active Ingredient Benzethonium Chloride @ 0.13%

🧪 Inactive Ingredients 32 words ▾

Inactive Ingredients: Benzyl Alcohol, Cetrimonium Chloride, Citric Acid, Cocamide MEA, Cocamidopropylamine Oxide, Fragrance, Glycerin, PEG-200 Glyceryl Stearate, Red 4, Salicylic Acid, Sorbic Acid, Tetrasodium EDTA, Water, Yellow 5, (may contain Sodium Hydroxide)

🎯 Purpose 2 words ▾

Purpose Antiseptic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68599-5401-00 · McKesson 68599-5502-01 · McKesson →
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.