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AFFEX Antibacterial Plum Foam Handwash Benzalkonium Chloride .005 mg/mL Liquid, 1250 mL — NDC 54057-400-42 (Billing 54057-0400-42)

by Afflink, Inc. · 1250 mL in 1 PACKAGE

This is a package of 1,250 mL of AFFEX Antibacterial Plum Foam Handwash Benzalkonium Chloride .005 mg/mL Liquid from Afflink, Inc., marketed since Apr 2017 and currently FDA-listed.

NDC 54057-0400-42
🏷️ FDA NDC (as labeled) 54057-400-42 billing pads the product segment with a zero
This package
Contains1250 mL Pack sizes2 compare ↓
Product page 54057-0400-40 Also comes in: 1200 ml 54057-400-40
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) 54057-400-42
Product NDC 54057-400
11-digit billing NDC 54057040042
UNII F5UM2KM3W7
Application # 505G(a)(3)
SPL Set ID 3f51700a-0e8f-4091-ab0d-6751364304a4
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-04-30
Route TOPICAL
Dosage form LIQUID
Substance BENZALKONIUM CHLORIDE
Why two NDCs? The FDA registers this code as 54057-400-42 — 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 → 54057-0400-42. 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.

Clinical

🧪 What is this product?

Affex Antibacterial Plum Foam Handwash is a topical liquid soap product marketed as an over-the-counter monograph drug. It contains benzalkonium chloride, a synthetic antimicrobial agent commonly used in antibacterial hand soaps and skin cleansers to help reduce bacteria on the hands and skin. This product is designed for use as a routine handwash and functions through the topical application of the antimicrobial ingredient to help limit bacterial growth on the skin surface.

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 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: 1200 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
54057-0400-40 54057-400-40 Main listing 1200 mL in 1 PACKAGE 2017-04-30 — Active
54057-0400-42 You're viewing this 1250 mL in 1 PACKAGE 2017-04-30 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 1250 mL — 1250 ml in 1 package.
How does this package differ from NDC 54057-0400-40?
Both are AFFEX Antibacterial Plum Foam Handwash Benzalkonium Chloride .005 mg/mL Liquid — the drug itself is identical. This page's package is the 1250 mL one, while NDC 54057-0400-40 is the 1200 ml package.
What NDC number is used to bill for this package of AFFEX Antibacterial Plum Foam Handwash Benzalkonium Chloride .005 mg/mL Liquid?
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
Antibacterial Plum Foam Handwash .005 mg/mL 61666-0008-23 Waxie 700 ml — — FDA listed —
DON Antibacterial Plum Foam Handwash .005 mg/mL 66910-0400-40 Edward 1200 ml — — FDA listed —
PURELL HEALTHY SP 0.5pct BAK Antimicrobial Foam .005 mg/mL 21749-0684-40 GOJO 1200 ml — — FDA listed —
PRIME SOURCE SELECT Plum Antibacterial Foam Hand So ap .005 mg/mL 66294-0402-40 BUNZL 1200 ml — — FDA listed —
PRO-LINK Antibacterial Plum Perfection Foam So ap .005 mg/mL 66908-0400-23 Pro-Link, 700 ml — — FDA listed —
BRIGHTON PROFESSIONAL Antibacterial Plum Foam Handwash .005 mg/mL 49514-0400-23 Staples 700 ml — — FDA listed —
CLASSIC TOUCH Antibacterial Plum Foam Handwash .005 mg/mL 54057-0401-40 AFFLAB, 1200 ml — — FDA listed —
HygienePoint Advance Antibacterial F oam Hand Cleaner .005 mg/mL 59110-0401-40 Triple 1200 ml — — FDA listed —
PRIME SOURCE Antibacterial Foam Handwash .005 mg/mL 66294-0400-23 BUNZL 700 ml — — FDA listed —
PURELL Foodservice HEALTHY SP 0.5pct BAK Antimicrobial Foam .005 mg/mL 21749-0686-23 GOJO 222 ml — — Discontinued —
RENOWN Antibacterial Plum Handwash .005 mg/mL 71896-0400-23 Interline 700 ml — — FDA listed —
PURELL Healthcare HEALTHY SP 0.5 BAK Antimicrobial Foam .005 mg/mL 21749-0687-40 GOJO 1200 ml — — Discontinued —
ARRAY Plum Scent Antibacterial Foam Handwash .005 mg/mL 52220-0400-40 Gordon 1200 ml — — FDA listed —
PRIME SOURCE ULTRA Energy Plum Antibacterial Foam Hand So ap .005 mg/mL 66294-0401-40 BUNZL 1200 ml — — FDA listed —
Pro Formance Plum Perfection Antibacterial Foam S oap .005 mg/mL 66908-0401-40 Pro-Link, 1200 ml — — FDA listed —
Victoria Bay Antibacterial Plum Foam Handwash .005 mg/mL 71907-0400-23 Dade 700 ml — — FDA listed —
RENOWN Antibacterial Plum Handwash .005 mg/mL 42584-0400-01 Home 1200 ml — — Discontinued —
AFFEX Antibacterial Plum Foam Handwash .005 mg/mLthis 54057-0400-42 Afflink, 1250 ml — — FDA listed —
BRIGHT SOLUTIONS Antibacterial Plum Foam Handwash .005 mg/mL 66885-0400-40 Kel-San, 1200 ml — — FDA listed —
EXTENDED CARE Antimicrobial Plum Foam Handwash .005 mg/mL 71875-0400-23 TRIPLE 700 ml — — FDA listed —
Elevate TF Foam Skin Care Advance Antibacterial Foam Hand Cleaner .005 mg/mL 59110-0400-40 Triple 1200 ml — — FDA listed —
Reliable Luxury Foam Antimicrobial Handwash Citrus Floral Scent .005 mg/mL 71897-0401-40 Veritiv 1200 ml — — FDA listed —
Reliable Hand So ap Antibacterial Plum .005 mg/mL 71897-0523-40 Veritiv 1200 ml — — FDA listed —
SMART Antibacterial Plum Foam Handwash .005 mg/mL 71908-0400-40 Southeastern 1200 ml — — FDA listed —
GOJO Antibacterial Plum Foam Handwash with Biobased content .005 mg/mL 21749-0853-89 GOJO 1200 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
Apr 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.

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.

Manufacturer & labeler

LabelerAfflink, Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code54057
First marketedApr 2017
Product typeHuman Otc Drug
Portfolio3 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Uses • Handwash to help decrease bacteria on the skin • Recommended for repeated use

⏱️ Dosage and Administration 23 words ▾

Directions • Wet hands • Apply a small amount of product and work into a lather • Rinse well and dry hands completely

⚠️ Warnings 58 words ▾

Warnings For external use only When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active ingredient Benzalkonium Chloride 0.5%

🧪 Inactive Ingredients 29 words ▾

Inactive Ingredients Water (Aqua), Propylene Glycol, Glycerin, Cocamidopropyl Betaine, PEG-80 Sorbitan Laurate, Citric Acid, Ethylhexylglycerin, Lauramine Oxide, Polyquaternium-10, Fragrance (Parfum), Phenoxyethanol, Blue 1 (CI 42090), Red 33 (CI 17200)

🎯 Purpose 2 words ▾

Purpose Antimicrobial

📄 When Using This Product 21 words ▾

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

📄 Stop Use and Ask a Doctor If 13 words ▾

Stop use and ask a doctor if irritation or rash appears and lasts

📄 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.

📄 Package Label / Principal Display Panel 2 words ▾

Product Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 AFFEX Antibacterial Plum Foam Handwash (this brand).

Top reported reactions

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

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
2020 2022 2024 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.

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 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 Afflink, 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 1 other package presentation of this same product, including 1200 ml (54057-0400-40). 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?
Afflink, 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.
← 54057-0083-42 · Afflink, 54057-0401-40 · AFFLAB, →
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.