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3M DuraPrep Surgical Iodine Povacrylex and Isopropyl Alcohol 6.02 mg/mL; 636.4 mg/mL Solution

by Solventum US LLC · 1 APPLICATOR in 1 CASE (17518-011-07) / 6 mL in 1 APPLICATOR
NDC 17518-0011-07
🏷️ FDA NDC (as labeled) 17518-011-07 billing pads the product segment with a zero
This package
Contains6 mL in 1 applicator Pack sizes2 compare ↓
Also comes in: 26 mL 17518-0011-08
OTC Brand 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 →

🆔 Identity & classification

FDA NDC (as labeled) 17518-011-07
Product NDC 17518-011
11-digit billing NDC 17518001107
NCPDP billing unit ML — per mL (volume)
RxCUI 692866, 1090522
UNII 6E43AWY083, ND2M416302
Application # NDA021586
SPL Set ID 22a10a54-6a04-48b3-9ec4-b26526183daf
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-09-29
Route TOPICAL
Dosage form SOLUTION
Substance IODINE POVACRYLEX; ISOPROPYL ALCOHOL
GCN Seq No 075492
GCN 40583
HICL code 043018
Ingredient (HICL) Iodine Povacrylex/Iso Alcohol
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W8
Therapeutic class — intermediate (HIC2) Antiseptics
HIC3 code W8C
Therapeutic class — specific (HIC3) Iodine Antiseptics
AHFS code 84:04.92.00
AHFS class Local Anti-Infectives, Miscellaneous
FDB label name DURAPREP 0.7%-74% SOLUTION
FDB brand name Duraprep
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 17518-011-07 — 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 → 17518-0011-07. 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.

🏭 Manufacturer & labeler

LabelerSolventum US LLC
Application holderSOLVENTUM US LLC
FDA applicationNDA021586 (NDA)
Labeler code17518
First marketedSep 2006
Product typeHuman Otc Drug
Portfolio19 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

Label name DURAPREP 0.7%-74% SOLUTION Ingredient Iodine Povacrylex/Iso Alcohol
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 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.

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

The official label also statesethyl alcohol, 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 DailyMedingredient 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: 26 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
3M DuraPrep Surgical 6.02 mg/mL; 636.4 mg/mLthis 17518-0011-07 Solventum 1 applicator FDA listed
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2006
On the market since
Sep 2006
📍
2026
Currently FDA-listed
20 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
17518-0011-07 You're viewing this 1 APPLICATOR in 1 CASE (17518-011-07) / 6 mL in 1 APPLICATOR 2006-09-29 Active
17518-0011-08 1 APPLICATOR in 1 CASE (17518-011-08) / 26 mL in 1 APPLICATOR 2006-09-29 Active

Pack size FAQ

What quantity is in NDC 17518-0011-07?
NDC 17518-0011-07 is listed by the FDA — 1 applicator in 1 case / 6 ml in 1 applicator.
What NDC number is used to bill for this package of 3M DuraPrep Surgical Iodine Povacrylex and Isopropyl Alcohol 6.02 mg/mL; 636.4 mg/mL Solution?
Bill NDC 17518-0011-07 — the 11-digit billing format is 17518001107. 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 — Not published for this NDC No photo available yet for this listing.
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

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 17518-011-07, 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: 17518-0011-07, written without dashes as 17518001107. 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 17518-0011-07, the first segment (17518) is the labeler code FDA assigned to Solventum US LLC; the middle segment (0011) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) 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 Solventum US 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 (17518-0011-08). 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?
Solventum US 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.

📄 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 22 words

Uses patient preoperative skin preparation: for preparation of the skin prior to surgery helps reduce bacteria that potentially can cause skin infection

⏱️ Dosage and Administration ~2 min read

Directions (follow all directions for use) at the end of the prep, discard any portion of the solution which is not required to cover the prep area. It is not necessary to use the entire amount available. Getting Patient Ready for Solution: use in well-ventilated area do not microwave or heat the solution applicator apply to clean, completely dry, residue-free, intact skin when hair removal is necessary, use a surgical clipper on the morning of the surgery.

If a wet shave is used, thoroughly remove all soap residues. Activating the Applicator: grasp product by wrapping hand and fingers around the labeled portion of the applicator. Place thumb on the lever. with sponge face parallel to the floor, snap lever.

Allow all fluid to flow into sponge. When Applying Solution: DO NOT SCRUB . Paint a single, uniform application and do not reprep area. do not allow solution to pool .

Use sponge applicator to absorb excess solution and continue to apply a uniform coating. If solution accidentally gets outside of prep area, remove excess with gauze. tuck prep towels as needed under both sides of the neck to absorb excess solution. Remove towels before draping. avoid getting solution into hairy areas.

Wet hair is flammable . Hair may take up to 1 hour to dry. when prepping skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry. Otherwise, skin may adhere to itself.

After Applying Solution: to reduce the risk of fire, wait until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) . Solution will turn from a shiny to a dull appearance on skin alerting the user that the solution is completely dry and no longer flammable. While Waiting for Solution to Completely Dry: do not drape or use ignition source (e.g., cautery, laser) check for pooled solution.

Use sterile gauze to soak up pooled solution. Do not blot because it may remove solution from skin. remove solution-stained materials. Replace if necessary.

After Solution is Completely Dry: to reduce the risk of fire, begin draping and/or using cautery only after solution is completely dry and all solution-stained materials are removed if incise drapes are used, apply directly to dry prep. On completion of surgical procedure, removal of incise drape will remove film. apply dressing following standard practices

⚠️ Warnings ~1 min read

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

Wet hair is flammable . Hair may take up to 1 hour to dry. do not allow solution to pool remove solution-stained material from prep area Do not use on patients with known allergies to iodine or any other ingredients in this product on open wounds, on mucous membranes, or as a general skin cleanser in infants less than 2 months old due to the risk of excessive skin irritation and transient hypothyroidism When using this product keep out of eyes, ears, and mouth. May cause serious injury if permitted to enter and remain.

If contact occurs, flush with cold water right away and contact a doctor. to avoid skin injury, care should be taken when removing drapes, tapes, etc…applied over film 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 irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. On rare occasions, use of this product has been associated with skin blistering.

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

🧪 Active Ingredient 11 words

Active ingredients Iodine povacrylex (0.7% available iodine) Isopropyl alcohol, 74% w/w

🧪 Inactive Ingredients 5 words

Inactive ingredients ethyl alcohol, water

🎯 Purpose 3 words

Purpose Antiseptic Antiseptic

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