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SENTRY ANTISEPTIC HANDSOAP CHLOROXYLENOL 3 mg/mL Soap, 3785 mL — NDC 31507-544-14 (Billing 31507-0544-14)

by Wechem, Inc. · 3785 mL in 1 BOTTLE, PLASTIC

This is a package of 3,785 mL of SENTRY ANTISEPTIC HANDSOAP CHLOROXYLENOL 3 mg/mL Soap from Wechem, Inc., marketed since Oct 2023 and currently FDA-listed. It is this product's only package size.

NDC 31507-0544-14
🏷️ FDA NDC (as labeled) 31507-544-14 billing pads the product segment with a zero
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

NDC database record

One package, one record: these facts belong to NDC 31507-544-14 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
31507 labeler · 544 product · 14 package
Package marketed since
Oct 31, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 3150754414 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 31507-544-14
Product NDC 31507-544
11-digit billing NDC 31507054414
RxCUI 413261
UNII 0F32U78V2Q
Application # 505G(a)(3)
SPL Set ID 09041e53-4ca8-9992-e063-6394a90a3062
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-30
Route TOPICAL
Dosage form SOAP
Substance CHLOROXYLENOL
Quick answers
  • RxCUI (RxNorm): 413261
Why two NDCs? The FDA registers this code as 31507-544-14 — 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 → 31507-0544-14. 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.

Clinical

🧪 What is this product?

This is an over-the-counter antiseptic hand soap containing chloroxylenol as its active ingredient. Chloroxylenol is an antimicrobial compound that is typically used in topical soap products to help reduce bacteria on the skin during hand washing. The product is marketed under the FDA's OTC monograph rules for antiseptic soaps, meaning it follows an established regulatory framework for this category rather than being individually approved. It is intended for routine hand hygiene and cleaning.

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.

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 eachPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
31507-0544-14 You're viewing this Main listing 3785 mL in 1 BOTTLE, PLASTIC 2023-10-31 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lemon Drop Gentle Antiseptic 3 mg/mL 11429-1006-01 Woodbine 118 ml — — FDA listed —
Simplify Antibacterial Hand Apple Blossom Scent .3 g/100mL 11822-0281-01 Rite 573 ml — — Discontinued —
Antiseptic Hand 3 mg/mL 16496-0544-14 Image 3785 ml — — FDA listed —
Renown Antibacterial Hand 3000 mg/L 18949-0051-00 HD 3.78 l — — FDA listed —
Symmetry Antimicrobial Foaming Hand Wash .3 g/100mL 30805-0006-02 Buckeye 1250 ml — — FDA listed —
Altra Antimicrobial Foaming Hand Wash with 0.3% PCMX .3 g/100mL 30805-0016-02 Buckeye 1250 ml — — Discontinued —
Sentry Antiseptic Handsoap 3 mg/mLthis 31507-0544-14 Wechem, 3785 ml — — FDA listed —
Hand Guard High Foaming Antiseptic Hand and Body Wash 3 mg/mL 31507-0876-01 Wechem, 1200 ml — — Discontinued —
Chloroxylenol 0.30 % 3 mg/mL 42669-0028-03 Davion, 828 ml — — FDA listed —
Fm-24 Foaming 3 mg/mL 43097-0876-01 People's 1200 ml — — Discontinued —
Sani Foam Mango Antiseptic Hand and Body Wash 3 mg/mL 43374-0876-10 Delta 1000 ml — — Discontinued —
Pearl Antimicrobial Hand Item 1027Ab-01 .3 g/100mL 50536-0127-01 AMERICAN 3785 ml — — FDA listed —
Soft Touch Plus Antibacterial Hand Item 1039 .3 g/100mL 50536-0139-01 AMERICAN 3785 ml — — FDA listed —
Super Suds Antibacterial Hand Item 1063 .3 g/100mL 50536-0163-01 AMERICAN 3785 ml — — FDA listed —
E-2 Hand Item 1095 .3 g/100mL 50536-0195-01 AMERICAN 3785 ml — — FDA listed —
Golden Medicated .3 g/100mL 50865-0060-09 Kutol 3785 ml — — FDA listed —
Xtra Antibacterial Hand Juicy Orange 3 mg/mL 51628-0033-00 MY 709 ml — — FDA listed —
Ultra 3 mg/mL 55910-0589-44 Old 532 ml — — Discontinued —
Triclosan Free Antibacterial Antibacterial .3 g/100mL 57337-0086-01 Rejoice 443 ml — — FDA listed —
Triclosan Free Antibacterial 7.5 oz original Antibacterial .3 g/100mL 57337-0087-01 Rejoice 221 ml — — FDA listed —
Triclosan Free Antibacterial 7.5 oz (Ocean) Antibacterial .3 g/100mL 57337-0088-01 Rejoice 221 ml — — FDA listed —
Triclosan Free Antibacterial 7.5 oz (Strawberry Pomegranate) Antibacterial .3 g/100mL 57337-0089-01 Rejoice 221 ml — — FDA listed —
Triclosan Free Antibacterial 7.5 oz (Fresh Citrus) Antibacterial .3 g/100mL 57337-0090-01 Rejoice 221 ml — — FDA listed —
Chemseptic 3 mg/mL 59503-0544-01 Rochester 532 ml — — Discontinued —
Antibacterial Foamy Mango High Foaming Antiseptic Hand and Body Wash 3 mg/mL 60456-0876-01 Carpet 1200 ml — — Discontinued —
Franklin cleaning technology antibacterial hand 3 mg/mL 60933-0056-00 Fuller 3790 ml — — FDA listed —
1012 Antimicrobial 3 mg/mL 62257-0012-06 ABC 800 ml — — Discontinued —
Lynx Antibacterial 3 mg/mL 62257-0160-01 ABC 1200 ml — — Discontinued —
Lynx Foamy PCMX Antiseptic Hand and Body Wash 6876 3 mg/mL 62257-0161-01 ABC 1200 ml — — Discontinued —
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380 3 mg/mL 62257-0380-12 ABC 1000 ml — — FDA listed —
Palm 3 mg/mL 62257-0544-06 ABC 800 ml — — FDA listed —
Lynx LX0864 peachy-foam antiseptic handsoap 3 mg/mL 62257-0686-12 ABC 1000 ml — — FDA listed —
Sani Mango Antiseptic Hand and Body Wash 3 mg/mL 62257-0875-01 ABC 1200 ml — — Discontinued —
Sani Mango Antiseptic Hand and Body Wash 3 mg/mL 62257-0876-01 ABC 1200 ml — — FDA listed —
Handtastic Foamy Mango Antiseptic Hand and Body Wash 3 mg/mL 63533-0876-01 Momar 1200 ml — — Discontinued —
Suds High Foaming Antiseptic Hand and Body Wash 3 mg/mL 63830-0876-01 Pro 1200 ml — — Discontinued —
Fresh Start 3 mg/mL 63830-0950-06 Pro 800 ml — — FDA listed —
Surgent Antiseptic 3 mg/mL 66155-0544-01 SunCoast 1200 ml — — Discontinued —
Zep Applaud AB .3 g/100mL 66949-0123-01 Zep 11400 ml — — FDA listed —
Inoderm Style Antibacterial 3 mg/.001L 73062-0055-00 Avro 3.8 l — — FDA listed —
Inoderm Choice Antibacterial 3 mg/mL 73062-0523-42 Avro 3800 ml — — FDA listed —
Kroger Antibacterial Green Apple Hand .3 g/100mL 73487-0001-01 Korex 709 ml — — Discontinued —
Power Force Antibacterial Handsoap Green Apple Scent .3 g/100mL 73487-0008-01 Korex 709 ml — — FDA listed —
Power Force Antibacterial Handsoap Citrus Scent .3 g/100mL 73487-0009-01 KOREX 709 ml — — FDA listed —
Freshands Premium Foamy Antibacterial Handsoap 6876 3 mg/mL 75632-0876-14 Consolidated 3785 ml — — Discontinued —
Satin Foam High Foaming Antiseptic Hand Wash 3 mg/mL 75990-0914-03 Certus 750 ml — — FDA listed —
Green Antibacterial Dish and HandSoap 30 mg/10mL 79481-0200-02 Meijer, 709 ml — — FDA listed —
TOTO Antibacterial Foam HandSoap 3 mg/mL 84791-0686-05 Toto 18927 ml — — FDA listed —
Ban-Aid 3 mg/mL 63830-0544-06 Pro 800 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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

LabelerWechem, Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code31507
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from Wechem, Inc. labeler code 31507

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 ▾

Drug Facts Box OTC-Indications & Usage Section for hand-washing to decrease bacteria on the skin

⏱️ Dosage and Administration 28 words ▾

Drug Facts Box OTC-Dosage & Administration Section wet hands and forearms apply 5 milliliters (teaspoonful) or palmful to hands and forearms scrub thoroughly for 1 minute and rinse

⚠️ Warnings 9 words ▾

Drug Facts Box OTC-Warnings Section For external use only

🧪 Active Ingredient 8 words ▾

Drug Facts Box OTC-Active Ingredient Section Chloroxylenol 0.3%

🧪 Inactive Ingredients 32 words ▾

Drug Facts Box OTC-Inactive Ingredient Section water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, sodium chloride, citric acid, DMDM hydantoin, fragrance, FD and C yellow no.5, FD&C Red # 40

🎯 Purpose 6 words ▾

Drug Facts Box OTC-Purpose Section Antiseptic

📄 When Using This Product 19 words ▾

Drug Facts Box OTC-When Using Section do not get into eyes if contact occurs, rinse eyes thoroughly with water

📄 Stop Use and Ask a Doctor If 10 words ▾

Drug Facts Box OTC-Stop Use Section irritation and redness develop

📄 Keep Out of Reach of Children 23 words ▾

Drug Facts Box OTC-Keep Out of Reach of Children Section if swallowed, get medical help or contact a Poison Control Center right away

📄 Package Label / Principal Display Panel 5 words ▾

Sentry Antiseptic Handsoap Sentry 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 SENTRY ANTISEPTIC HANDSOAP (this brand).

Top reported reactions

Vomiting2
Abdominal Pain Lower1
Abdominal Pain Upper1
Anaemia1
Cholecystitis1
Cystitis1
Drug Effect Decreased1

Age at onset

Elderly1

Reporter sex

7 reports
Male · 14%
Female · 86%

Serious outcomes

Hospitalization3
Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2025 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.

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 Wechem, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Wechem, 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.
← 31507-0024-24 · Wechem, 31507-0585-08 · Wechem, →
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.