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AFCO 5508 Sanifect Foam-E II Ethanol 2081980 mg/208198mL Liquid, 208198 mL — NDC 66949-0139-01 package photo

AFCO 5508 Sanifect Foam-E II Ethanol 2081980 mg/208198mL Liquid, 208198 mL

by Zep Inc. · 208198 mL in 1 DRUM (66949-139-01)
NDC 66949-0139-01
🏷️ FDA NDC (as labeled) 66949-139-01 billing pads the product segment with a zero
This package
Contains208198 mL Pack sizes3 compare ↓
Also comes in: 3785 ml 66949-0139-03 6000 ml 66949-0139-02
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 Ethanol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 22, 2026 — Microbial contamination of sterile products (Zep Inc) · FDA recall D-0586-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 66949-139-01
Product NDC 66949-139
11-digit billing NDC 66949013901
RxCUI 413257
UNII 0F32U78V2Q
Application # 505G(a)(3)
SPL Set ID 347995ef-38bd-7cdb-e063-6394a90adec3
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-05
Marketing end 2026-12-31
Route TOPICAL
Dosage form LIQUID
Substance CHLOROXYLENOL
Why two NDCs? The FDA registers this code as 66949-139-01 — 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 → 66949-0139-01. 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 Phenol and derivatives class.

Drug family (ATC) Phenol and derivatives
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

LabelerZep Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code66949
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio28 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?

This is a topical liquid foam product containing chloroxylenol, an antimicrobial agent. Chloroxylenol is typically used in antiseptic and antimicrobial skin cleansers to reduce bacteria and other microorganisms on the skin surface. This product is marketed as an over-the-counter monograph drug, meaning it is formulated under FDA's established guidelines for this category of antimicrobial cleansing products rather than as an individually reviewed drug application.

4
Nutrient depletion considerations

Ethanol may be associated with lower levels of 4 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Ethanol nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 698O4Z48G6
    A synthetic cleaning agent derived from coconut oil. Used as a surfactant and emulsifier to help blend water and oil-based ingredients together in liquid or semi-solid formulations.
  • UNII Q7AO2R1M0B
    Ammonium lauryl sulfate is a mild detergent and foaming agent derived from plant oils. It helps mix water and oil-based ingredients together and creates a light foam in topical formulations like shampoos and cleansers.
  • 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 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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.

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

The official label also statesWater, Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Ethyl Alcohol, Propylene Glycol, Cocamide MEA, Glycerin, Disodium EDTA.

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: 3785 ml 6000 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
Kindest Kare Hand Antimicrobial Handwash 1 g/100mL 11084-0036-41 SC 1000 ml — — FDA listed —
Acute-Kare Healthcare Personnel Handwash 1 g/100mL 11084-0800-41 SC 1000 ml — — FDA listed —
DigiClean E 1 mg/100mL 47593-0308-41 Ecolab 750 ml — — FDA listed —
Ecolab 10 mg/mL 47593-0506-41 Ecolab 750 ml — — FDA listed —
VioNexus 1 g/100mL 55443-0600-03 Metrex 2 bottles — — FDA listed —
SoftenSure Foam Antimicrobial 10 mg/mL 59900-0127-05 Best 1250 ml — — FDA listed —
Soften Sure Foam Antimicrobial 10 g/1000mL 59900-0211-06 Best 1000 ml — — FDA listed —
Prestige 10 mg/mL 63621-0335-14 Sunburst 3785 ml — — FDA listed —
FoamyIQ Healthcare Personnel Handwash 10.11 g/L 64009-0203-06 Spartan 1.25 l — — FDA listed —
Lite nFoamy Healthcare Personnel Handwash 10.11 g/L 64009-0335-82 Spartan 532 l — — FDA listed —
Antiseptic Hand Cleaner 10.11 g/L 64009-0336-85 Spartan 3.79 l — — FDA listed —
Clean Xpress Antiseptic Hand Cleaner 10 mg/mL 64009-0338-02 Spartan 1000 ml — — FDA listed —
Soft Care Defend Foam Antibacterial Handwash 1 g/100mL 64536-8308-02 Diversey, 1200 ml — — Discontinued —
Soft Care Defend Antibacterial Handwash 1 g/100mL 64536-8748-02 Diversey, 1200 ml — — Discontinued —
Soft Care Defend Antibacterial Handwash 10 g/L 64536-8760-02 Diversey, 3.78 l — — FDA listed —
WhiskCare 365 10 mg/mL 65585-0365-02 Whisk 3785 ml — — FDA listed —
AFCO 5508 Sanifect Foam-E II 2081980 mg/208198mLthis 66949-0139-01 Zep 208198 ml — — FDA listed —
AFCO 5508 Sanifect Foam-E II 2081980 mg/208198mL 66949-0141-01 Zep 208198 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

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year 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 AFCO 5508 Sanifect Foam-E II (this brand).

Top reported reactions

Completed Suicide2,795
Toxicity To Various Agents1,745
Drug Abuse1,625
Death1,131
Cardiac Arrest841
Cardio-respiratory Arrest805
Respiratory Arrest762

Reporter sex

7,955 reports

Serious outcomes

Death6,941
Disabling15
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 2 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
66949-0139-01 You're viewing this 208198 mL in 1 DRUM (66949-139-01) 2025-05-05 Active
66949-0139-02 6000 mL in 1 CASE (66949-139-02) 2025-05-05 Active
66949-0139-03 3785 mL in 1 CASE (66949-139-03) 2025-05-05 Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 66949-0139-01?
NDC 66949-0139-01 contains 208198 mL — 208198 ml in 1 drum.
What is the difference between NDC 66949-0139-01 and NDC 66949-0139-03?
Both are AFCO 5508 Sanifect Foam-E II Ethanol 2081980 mg/208198mL Liquid — the drug itself is identical. NDC 66949-0139-01 is the 208198 mL package, while NDC 66949-0139-03 is the 3785 ml package.
What NDC number is used to bill for this package of AFCO 5508 Sanifect Foam-E II Ethanol 2081980 mg/208198mL Liquid?
Bill NDC 66949-0139-01 — the 11-digit billing format is 66949013901. 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 66949-139-01, 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: 66949-0139-01, written without dashes as 66949013901. 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 66949-0139-01, the first segment (66949) is the labeler code FDA assigned to Zep Inc.; the middle segment (0139) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 it is currently marketed — but Zep Inc. has reported a marketing end date of 2026-12-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 3785 ml (66949-0139-03), 6000 ml (66949-0139-02). 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?
Zep 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 25 words ▾

Uses Hand wash to help reduce bacteria on skin that potentially can cause diseases. Helps prevent cross contamination by hand contact. Recommended for repeat use.

⏱️ Dosage and Administration 34 words ▾

Directions For one step hand washing and sanitizing, wet hands with water. Apply a generous amount of product in palm of hand and work into later. Rinse thoroughly with potable water. Dry hands completely.

⚠️ Warnings 9 words ▾

Warnings For external use only – Harmful if swallowed.

🧪 Active Ingredient 5 words ▾

Active ingredient Chloroxylenol 1.0% w/w

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients Water, Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Ethyl Alcohol, Propylene Glycol, Cocamide MEA, Glycerin, Disodium EDTA.

🎯 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 ↗
← 66949-0137-08 · Zep 66949-0140-01 · Zep →
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.