NDC 63621-0335-14 — Prestige Chloroxylenol 10 mg/mL Soap, 3785 mL

🆔 Identity & classification

FDA NDC (as labeled) 63621-335-14

Product NDC 63621-335

11-digit billing NDC 63621033514

RxCUI 413257

UNII 0F32U78V2Q

Application # 505G(a)(3)

SPL Set ID 2e4bb97c-9c16-43d1-aea3-54723c7afc45

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2020-04-03

Route TOPICAL

Dosage form SOAP

Substance CHLOROXYLENOL

Why two NDCs? The FDA registers this code as 63621-335-14 — 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 → 63621-0335-14. 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.

🏭 Manufacturer & labeler

LabelerSunburst Chemicals, Inc.

FDA application505G(a)(3) (OTC MONOGRAPH DRUG)

Labeler code63621

First marketedApr 2020

Product typeHuman Otc Drug

Portfolio4 products on file

🔎 All NDCs from Sunburst Chemicals, Inc.

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?

Prestige Chloroxylenol 10 mg/mL Soap is a topical soap product marketed as an over-the-counter drug under FDA monograph rules. Chloroxylenol is an antimicrobial agent typically used in cleansing products to help reduce bacteria and microorganisms on the skin. This soap form is designed for routine handwashing and general skin cleaning purposes.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

💊 What it looks like

Color white

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 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 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 ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
UNII 4F6FC4MI8W
Lauramine oxide is a surfactant, a substance that helps mix oil and water together. It's used in medicines to improve how ingredients blend and to help the product dissolve or spread properly.
UNII 0L414VCS5Y
A synthetic polymer used as a film-former and conditioning agent. It helps create a protective coating on hair or skin surfaces and improves texture and manageability in topical formulations.
UNII O9W3D3YF5U
A synthetic surfactant derived from petroleum-based olefins. It helps dissolve or suspend active ingredients and other substances in liquid formulations, improving how the medicine mixes and flows.
UNII BPV390UAP0
Sodium laureth sulfate is a mild detergent and surfactant derived from coconut oil or petroleum. It helps mix oil and water in formulations and is often used as a cleaning or foaming agent in topical products like shampoos and cleansers.
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, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene/Acrylates Copolymer, Tetrasodium EDTA, Citric Acid

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 system	Per each	Per 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price 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/mLthis 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/208198mL 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

🏛️

2020

On the market since

Apr 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 Prestige (this brand).

Top reported reactions

Abdominal Pain Upper2

Vomiting2

Abdominal Distension1

Abdominal Pain Lower1

Anaemia1

Arthritis1

Arthropathy1

Age at onset

Adult1

Elderly1

Reporter sex

Male · 25%

Female · 75%

Serious outcomes

Hospitalization5

Life-threatening1

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
63621-0335-14 You're viewing this	3785 mL in 1 BOTTLE, PLASTIC (63621-335-14)	2020-04-03	Active

🧭 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 63621-335-14, 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: 63621-0335-14, written without dashes as 63621033514. 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 63621-0335-14, the first segment (63621) is the labeler code FDA assigned to Sunburst Chemicals, Inc.; the middle segment (0335) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (14) 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 Sunburst Chemicals, Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Sunburst Chemicals, 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 7 words ▾

Use reduces amount of bacteria on hands

⏱️ Dosage and Administration 28 words ▾

Directions Wet hands and forearms. Apply a small amount (5 mL) or palmful to hands and forearms. Scrub thoroughly for at least fifteen seconds. Rinse completely and dry.

⚠️ Warnings 44 words ▾

Warnings For external use only. Do not use in eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a physician. Not for use on children under 6 months of age. For institutional and professional use only.

🧪 Active Ingredient 5 words ▾

Active Ingredient Chloroxylenol 1% w/w

🧪 Inactive Ingredients 22 words ▾

Inactive Ingredients Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene/Acrylates Copolymer, Tetrasodium EDTA, Citric Acid

🎯 Purpose 3 words ▾

Purpose Skin Antimicrobial

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

🔗 Related NDC lookups

🧪 All Chloroxylenol NDCsSame ingredient 🏭 All Sunburst labeler NDCsLabeler code 63621 📖 Read the Chloroxylenol drug informationUses, warnings & side effects