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PurKlenz CHLOROXYLENOL 2.949 g/100mL Liquid, 3780 mL — NDC 49436-291-02 (Billing 49436-0291-02)

by PurKlenz Formulations Inc. · 3780 mL in 1 BOTTLE

This is a package of 3,780 mL of PurKlenz CHLOROXYLENOL 2.949 g/100mL Liquid from PurKlenz Formulations Inc., marketed since May 2012 and currently FDA-listed.

NDC 49436-0291-02
🏷️ FDA NDC (as labeled) 49436-291-02 billing pads the product segment with a zero
This package
Contains3780 mL Pack sizes4 compare ↓
Product page 49436-0291-01 Also comes in: 500 ml 49436-291-05 900 ml 49436-291-01 1000 packets 49436-291-03
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 49436-291-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
49436 labeler · 291 product · 02 package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4943629102 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49436-291-02
Product NDC 49436-291
11-digit billing NDC 49436029102
RxCUI 247396, 1537468
UNII 0F32U78V2Q
Application # M003
SPL Set ID 9f1223a8-a256-46f0-b01d-01b32ca09d48
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-05-01
Route TOPICAL
Dosage form LIQUID
Substance CHLOROXYLENOL
Quick answers
  • RxCUI (RxNorm): 247396
Why two NDCs? The FDA registers this code as 49436-291-02 — 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 → 49436-0291-02. 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 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?

PurKlenz Chloroxylenol is a topical liquid antiseptic product marketed as an over-the-counter monograph drug. The active ingredient, chloroxylenol, is an antimicrobial agent typically used in cleansers and antiseptic solutions to reduce bacteria on the skin. This product is commonly found in hand washes, body washes, and wound-cleansing preparations used for general hygiene and minor skin care.

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 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: 500 ml 900 ml 1000 packets
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
49436-0291-01 49436-291-01 Main listing 900 mL in 1 BOTTLE, PLASTIC 2012-05-01 — Active
49436-0291-02 You're viewing this 3780 mL in 1 BOTTLE 2012-05-01 — Active
49436-0291-03 49436-291-03 1000 PACKET in 1 BOX / 3.5 mL in 1 PACKET 2012-05-01 — Active
49436-0291-05 49436-291-05 500 mL in 1 BOTTLE, PLASTIC 2012-05-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 3780 mL — 3780 ml in 1 bottle.
How does this package differ from NDC 49436-0291-05?
Both are PurKlenz CHLOROXYLENOL 2.949 g/100mL Liquid — the drug itself is identical. This page's package is the 3780 mL one, while NDC 49436-0291-05 is the 500 ml package.
What NDC number is used to bill for this package of PurKlenz CHLOROXYLENOL 2.949 g/100mL 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
PurKlenz 2.949 g/100mLthis 49436-0291-02 PurKlenz 3780 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

🏛️
2012
On the market since
May 2012
📍
2026
Currently FDA-listed
14 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

LabelerPurKlenz Formulations Inc.
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code49436
First marketedMay 2012
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from PurKlenz Formulations Inc. labeler code 49436

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 7 words ▾

Uses To decrease bacteria on the skin

⏱️ Dosage and Administration 39 words ▾

Directions For best results do not dilute Apply as needed Scrub thoroughly for 30 seconds Wipe excess with sterile gauze Repeat - liquid only Massage package and remove towelette - towelette only Fold gauze and repeat - towelette only

⚠️ Warnings 72 words ▾

Warnings For external use only Do not use if you are allergic or sensitive to any of the ingredients listed When using this product avoid contact in or near eyes and mouth (oral mucosa). In case of eye contact, flush eyes with water. Stop and ask a doctor if irritation, rash or other allergic reaction develops. In case of accidental ingestion seek medical help or contact a Poison Control Center right away.

📦 Storage and Handling 27 words ▾

Other Information Other Information: Reseal container after use - liquid only Avoid freezing Store between 4° - 30° C (40-86° F) Dispose after use - towelette only

🧪 Active Ingredient 8 words ▾

Active Ingredient Drug Facts Active Ingredient: Chloroxylenol 3.0%

🧪 Inactive Ingredients 21 words ▾

Inactive Ingredients Water (aqua), Sodium Laureth Sulfate, Propylene Glycol, Cocamidopropyl Betaine, PPG-2 Hydroxyethyl Cocamide, Hypromellose, Citric Acid, Tetrasodium EDTA, Lanolin Oil

🎯 Purpose 3 words ▾

Purpose Purpose: Antiseptic

📄 Keep Out of Reach of Children 28 words ▾

Keep Out of Reach of Children Keep out of reach of children. In case of accidental ingestion seek medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 59 words ▾

PurKlenz Antiseptic Skin Cleaner Label - 30 FL Oz PurKlenz® Antiseptic Skin Cleanser Chloroxylenol 3.0 % NO PARABEN • ALCOHOL • DYE • FRAGRANCE• Contains No Paraben, Fragrance or Dye 30 FL. OZ. (900 mL) NDC 49436-291-01 Made in Canada Distributed in U.S.A. by PurKlenz Formulations Inc. Questions or Comments? www.purklenz.com PURKlenz PurKlenz Formulations Inc. PurKlenz AntisepticSkin 5 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 PurKlenz (this brand).

Top reported reactions

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

Reporter sex

0 reports

Serious outcomes

Hospitalization3
Life-threatening1
Death1
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 PurKlenz Formulations 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 3 other package presentations of this same product, including 500 ml (49436-0291-05), 900 ml (49436-0291-01), 1000 packets (49436-0291-03). 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?
PurKlenz Formulations 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.
← 49436-0099-30 · PURKLENZ 49436-0377-30 · PURKLENZ →
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.