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PurPrep povidone iodine and isopropyl alcohol 725 mg/mL; 8.3 mg/mL Sponge — NDC 54365-0014-42 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PurPrep povidone iodine and isopropyl alcohol 725 mg/mL; 8.3 mg/mL Sponge — NDC 54365-014-42 (Billing 54365-0014-42)

by CareFusion 213 LLC · 1 APPLICATOR in 1 POUCH / 26 mL in 1 APPLICATOR

This is a package of PurPrep povidone iodine and isopropyl alcohol 725 mg/mL; 8.3 mg/mL Sponge from CareFusion 213 LLC, marketed since Apr 2020 and currently FDA-listed.

NDC 54365-0014-42
🏷️ FDA NDC (as labeled) 54365-014-42 billing pads the product segment with a zero
This package
Contains26 mL in 1 applicator Pack sizes2 compare ↓
Product page 54365-0014-41 Also comes in: 10.5 mL 54365-014-41
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 54365-014-42 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
54365 labeler · 014 product · 42 package
Package marketed since
Apr 9, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5436501442 5
FDA record last changed
Jul 24, 2026
🚨
Active recall for this product.
Class II · Jun 11, 2026 — Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel (CareFusion 213, LLC) · FDA recall D-0644-2026
Lots / codes: Lot: 4298581, expires: 09/30/2026. · reported Jul 8, 2026
Class II · Apr 22, 2026 — Lack of assurance of Sterility: potential product contamination (CareFusion 213, LLC) · FDA recall D-0517-2026
Lots / codes: Lot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp. · reported May 13, 2026
Class II · Apr 22, 2026 — Lack of assurance of Sterility: potential product contamination (CareFusion 213, LLC) · FDA recall D-0518-2026
Lots / codes: Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026. · reported May 13, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 54365-014-42
Product NDC 54365-014
11-digit billing NDC 54365001442
RxCUI 1052725
UNII ND2M416302, 85H0HZU99M
Application # 505G(a)(3)
SPL Set ID a1c6e118-7861-c8d0-e053-2995a90aeaaa
Established class (EPC) Antiseptic
Chemical class Iodine
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-04-09
Route TOPICAL
Dosage form SPONGE
Substance ISOPROPYL ALCOHOL; POVIDONE-IODINE
Quick answers
  • RxCUI (RxNorm): 1052725
Why two NDCs? The FDA registers this code as 54365-014-42 — 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 → 54365-0014-42. 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.

RxNorm drug class

This medicine belongs to the Other antiseptics and disinfectants class.

Drug family (ATC) Other antiseptics and disinfectants
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?

PurPrep is a topical antiseptic sponge that combines two active ingredients commonly used to reduce bacteria and germs on the skin. Povidone-iodine is an iodine-based antiseptic typically applied to skin before medical procedures or to minor wounds, while isopropyl alcohol functions as a fast-acting antimicrobial agent. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for antiseptic products in this category rather than being individually reviewed and approved.

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.
Try another pack size: 10.5 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
54365-0014-41 54365-014-41 Main listing 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR 2020-05-21 — Active
54365-0014-42 You're viewing this 1 APPLICATOR in 1 POUCH / 26 mL in 1 APPLICATOR 2020-04-09 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 applicator in 1 pouch / 26 ml in 1 applicator.
What NDC number is used to bill for this package of PurPrep povidone iodine and isopropyl alcohol 725 mg/mL; 8.3 mg/mL Sponge?
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
PurPrep 725 mg/mL; 8.3 mg/mLthis 54365-0014-42 CareFusion 1 applicator — — 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.

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 LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII 71DD5V995L
    A synthetic polymer derived from acrylic acid, crosslinked to form a gel-like substance. It thickens formulations, improves texture, and helps distribute active ingredients evenly in topical products like creams and gels.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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.

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

The official label also statesAcrylates Copolymer, Acrylates/Octylacrylamide Copolymer, Aminomethyl Propanol, Polyethylene Glycol, USP Purified Water

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.

Manufacturer & labeler

LabelerCareFusion 213 LLC
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code54365
First marketedApr 2020
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from CareFusion 213 LLC labeler code 54365

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 42 words ▾

Use for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

Use for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

⏱️ Dosage and Administration ~1 min read ▾

Directions use in a well ventilated area do not allow solution to pool; tuck prep towels to absorb solution, and then remove remove applicator from package; do not touch sponge hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair).

Do not blot or wipe away. discard prepping materials, including solution soaked materials. It is not necessary to use the entire amount available.

Directions use in a well ventilated area do not allow solution to pool; tuck prep towels to absorb solution, and then remove remove applicator from package; do not touch sponge hold the applicator with the sponge down. Pinch wings only once to activate the ampules and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair).

Do not blot or wipe away. discard prepping materials, including solution soaked materials. It is not necessary to use the entire amount available.

⚠️ Warnings 187 words ▾

Warnings For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas.

Hair may take up to 1 hour to dry. Wet hair is flammable. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow the solution to pool remove wet materials from prep area

Warnings For external use only. Flammable, keep away from fire or flame. T o reduce risk of fire, PREP CAREFULLY: do not use 26-mL applicator for head and neck surgery solution contains alcohol and gives off flammable vapors . avoid getting solution into hairy areas.

Hair may take up to 1 hour to dry. Wet hair is flammable . do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow the solution to pool remove wet materials from prep area

🧪 Active Ingredient 34 words ▾

BD PurPrep™ 10.5 mL Applicator Active Ingredients Isopropyl Alcohol 7.2% w/w Povidone-Iodine 8.3% w/w (0.83% available iodine)

BD PurPrep™ 26 mL Applicator Active Ingredients Isopropyl Alcohol 72.5% w/w Povidone-iodine 8.3% w/w (0.83% available iodine)

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients Acrylates Copolymer, Acrylates/Octylacrylamide Copolymer, Aminomethyl Propanol, Polyethylene Glycol, USP Purified Water

Inactive ingredients Acrylates Copolymer, Acrylates/Octylacrylamide Copolymer, Aminomethyl Propanol, Polyethylene Glycol, USP Purified Water

🎯 Purpose 6 words ▾

Purposes Antiseptic Antiseptic

Purposes Antiseptic Antiseptic

📄 Do Not Use 114 words ▾

Do not use on children less than 2 months of age because of the potential for excessive skin irritation and increased drug absorption. Daily use of iodine on newborn infants may increase blood iodine level. on open skin wounds or as a general skin cleanser in the eyes or for prepping mucous membranes on iodine sensitive patients

Do not use on children less than 2 months of age because of the potential for excessive skin irritation and increased drug absorption. Daily use of iodine on newborn infants may increase blood iodine level. on open skin wounds or as a general skin cleanser in the eyes or for prepping mucous membranes on iodine sensitive patients

📄 When Using This Product 56 words ▾

When using this product use in well ventilated area use with caution in women who are breast-feeding due to the potential for transient hypothyroidism in the nursing newborn

When using this product use in well ventilated area use with caution in women who are breast-feeding due to the potential for transient hypothyroidism in the nursing newborn

📄 Stop Use and Ask a Doctor If 42 words ▾

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

📄 Keep Out of Reach of Children 38 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 32 words ▾

Other information store between 15-30 °C (59-86 °F) avoid excessive heat above 40 °C (104 °F)

Other information store between 15-30 °C (59-86 °F) avoid excessive heat above 40 °C (104 °F)

📄 Questions or Comments 16 words ▾

Questions? call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)

Questions? call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)

📄 Package Label / Principal Display Panel 130 words ▾

BD PurPrep™ 10.5 mL Applicator Package Label BD PurPrep™ 10.5 mL Applicator Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact NDC 54365-014-41 Ref 960110 10.5 mL Package Label

BD PurPrep™ 10.5 mL Applicator Carton Label BD PurPrep™ 10.5 mL Applicator Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact NDC 54365-014-41 Ref 960110 Carton Label

BD PurPrep™ 26 mL Applicator Package Label BD PurPrep™ 26 mL Applicator Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Patient Preoperative Skin Preparation Sterile Solution Applicator is sterile if package is intact NDC 54365-014-42 Ref 960120 26 mL Package Label

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

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 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 CareFusion 213 LLC. 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 1 applicator (54365-0014-41). 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?
CareFusion 213 LLC 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.
← 54348-0989-06 · PharmPak, 54365-0400-07 · CareFusion →
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.