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McKesson PVP Prep Solution Povidone-Iodine 1 mg/10mL Liquid — NDC 68599-3502-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

McKesson PVP Prep Solution Povidone-Iodine 1 mg/10mL Liquid — NDC 68599-3502-2 (Billing 68599-3502-02)

by McKesson Medical-Surgical · 36 BOTTLE in 1 CASE / 118 mL in 1 BOTTLE

This is a package of McKesson PVP Prep Solution Povidone-Iodine 1 mg/10mL Liquid from McKesson Medical-Surgical, marketed since Oct 2016 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 68599-3502-02
🏷️ FDA NDC (as labeled) 68599-3502-2 billing pads the package segment with a zero
This package
Contains118 mL in 1 bottle Pack sizes2 compare ↓
Main listing for product 68599-3502 · Also comes in: 24 bottles 68599-3502-6
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

⚠️
Other active recalls for Povidone-iodine (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Aug 19, 2025 — Subpotent drug (Medline Industries, LP) · FDA recall D-0674-2025
Class II · Sep 11, 2024 — Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000. (Zhejiang Jingwei Pharmaceutical Co., Ltd.) · FDA recall D-0013-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68599-3502-2
Product NDC 68599-3502
11-digit billing NDC 68599350202
UNII 85H0HZU99M
UPC 0612479213982, 0612479214002, 0612479281080, 0612479281073
Application # M003
SPL Set ID 33fa233c-b43c-42d8-af37-a58f098a0d51
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 2016-10-17
Route TOPICAL
Dosage form LIQUID
Substance POVIDONE-IODINE
Why two NDCs? The FDA registers this code as 68599-3502-2 — a 5-4-1 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 package segment → 68599-3502-02. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It's an antiseptic that lowers germs on the skin. Depending on the product, it's used to prep skin before surgery, as a hand scrub or hand wash, or as first aid for minor cuts, scr...
  • It goes on the skin, not in your mouth. Swabs are wiped on and thrown away after one use, and scrubs are lathered and rinsed. Follow the directions on your specific product, and do...
  • If it gets in your eyes, ears or mouth, rinse with cold water right away and contact a doctor. It can cause serious or permanent injury. If it's swallowed, get medical help or call...
  • What if it gets in my eyes or I swallow some?
📖 Read our full Povidone-Iodine guide →

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: 24 bottles
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
68599-3502-02 You're viewing this Main listing 36 BOTTLE in 1 CASE / 118 mL in 1 BOTTLE 2016-10-20 — Active
68599-3502-06 68599-3502-6 24 BOTTLE in 1 CASE / 237 mL in 1 BOTTLE 2017-03-13 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 36 bottle in 1 case / 118 ml in 1 bottle.
What NDC number is used to bill for this package of McKesson PVP Prep Solution Povidone-Iodine 1 mg/10mL 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
McKesson PVP Prep Solution 1 mg/10mLthis 68599-3502-02 McKesson 36 bottles — — FDA listed —
McKesson PVP Prep Solution 1 mg/10mL 68599-3500-02 McKesson 12 bottles — — 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

🏛️
2016
On the market since
Oct 2016
📍
2026
Currently FDA-listed
10 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

LabelerMcKesson Medical-Surgical
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code68599
First marketedOct 2016
Product typeHuman Otc Drug
Portfolio18 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.

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 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

Uses Health-care antiseptic preparation of the skin prior to surgery. First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.

⏱️ Dosage and Administration 52 words ▾

Directions For preparation of the skin prior to surgery Apply product to the operative site prior to surgery As a first aid antiseptic Clean the affected area Apply a small amount of this product on the area 1-3 times daily May be covered with a sterile bandage If bandaged, Let dry first

⚠️ Warnings 95 words ▾

Warnings For external use only Do not use in the eyes use as a first aid antiseptic Longer than one week use on individuals who are allergic or sensitive to iodine use on deep or puncture wounds use on animal bites use on serious burns apply over Large areas of the body Stop use and ask a doctor if conditions persists or gets worse irritation and redness develop and persists for more than 72 hours Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 9 words ▾

Active Ingredient Povidone-Iodine, 10% (equivalent to 1% available Iodine)

🧪 Inactive Ingredients 13 words ▾

Inactive ingredient Citric Acid, Disodium Phosphate, Glycerin, Purified Water, Sodium Citrate, Tween 80

🎯 Purpose 2 words ▾

Purpose Antiseptic

📄 Do Not Use 47 words ▾

Do not use in the eyes use as a first aid antiseptic Longer than one week use on individuals who are allergic or sensitive to iodine use on deep or puncture wounds use on animal bites use on serious burns apply over Large areas of the body

📄 Stop Use and Ask a Doctor If 23 words ▾

Stop use and ask a doctor if conditions persists or gets worse irritation and redness develop and persists for more than 72 hours

📄 Keep Out of Reach of Children 20 words ▾

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

📄 Other Information 20 words ▾

Other Information Do not store above 77°F (25°C) Do not store below 68°F (20°C) Not made with natural rubber latex.

📄 Package Label / Principal Display Panel ~3 min read ▾

Principal Display Panel - McKesson PVP Prep Solution 4 fl oz Carton label NDC 68599-3502-1 McKESSON PVP Prep Solution MFR# 039 USP 10% POVIDONE IODINE TOPICAL ANTISEPTIC MICROBICIDE NET CONTENTS 4 fl oz (118 mL) 039 each

Principal Display Panel - McKesson PVP Prep Solution 4 fl oz label NDC 68599-3502-2 McKESSON PVP Prep Solution USP 10% POVIDONE IODINE NET CONTENTS 4 fl oz (118 mL) 36 BOTTLES PER CASE Do not store above 77°F (25°C). Do not store below 68°F (20°C). Not made with natural rubber latex. Distributed By McKesson Medical-Surgical Inc. Richmond. VA 23233 PVN B0520 Made in Mexico LOT EXP MFR# 039 039 case

Principal Display Panel - McKesson PVP Prep Solution 16 fl oz Carton label NDC 68599-3500-1 McKESSON PVP Prep Solution USP 10% POVIDONE IODINE TOPICAL ANTISEPTIC MICROBICIDE NET CONTENTS 16 fl oz (473 mL) MFR# 035 035 Each

Principal Display Panel - McKesson PVP Prep Solution 16 fl oz label NDC 68599-3500-2 McKESSON PVP Prep Solution USP 10% POVIDONE IODINE NET CONTENTS 16 fl oz (473 mL) 12 BOTTLES PER CASE Do not store above 77°F (25°C). Do not store below 68°F (20°C). Not made with natural rubber latex. Distributed By McKesson Medical-Surgical Inc. Richmond. VA 23233 PVN B0520 Made in Mexico LOT EXP MFR# 035 035 case

Principal Display Panel - McKesson PVP Prep Solution 1 gal Carton label NDC 68599-3500-5 McKESSON PVP Prep Solution USP 10% POVIDONE IODINE TOPICAL ANTISEPTIC MICROBICIDE NET CONTENTS 1 gal (3.8 L) MFR# 036 036 each

Principal Display Panel - McKesson PVP Prep Solution 1 gal label NDC 68599-3500-6 McKESSON PVP Prep Solution USP 10% POVIDONE IODINE NET CONTENTS 1 gal (3.8 L) 4 BOTTLES PER CASE Do not store above 77°F (25°C). Do not store below 68°F (20°C). Not made with natural rubber latex. Distributed By McKesson Medical-Surgical Inc. Richmond. VA 23233 PNV B0520 Made in Mexico LOT EXP MFR# 036 036 case

Principal Display Panel - McKesson PVP Prep Solution 8 fl oz. label NDC 68599-3502-5 McKESSON PVP Prep Solution USP 10% POVIDONE IODINE TOPICAL ANTISEPTIC MICROBICIDE NET CONTENTS 8 fl oz (237 mL) MFR # 034 034 each

Principal Display Panel - McKesson PVP Prep Solution 8 fl. oz. Carton Label NDC 68599-3502-6 McKESSON PVP Prep Solution USP 10% POVIDONE IODINE NET CONTENTS 8 fl oz (237 mL) 24 BOTTLES PER CASE Do not store above 77°F (25°C). Do not store below 68°F (20°C). Not made with natural rubber latex. Distributed By McKesson Medical-Surgical Inc. Richmond. VA 23233 PVN B0520 Made in Mexico LOT EXP MFR# 034 034 case

NDC 68599-3500-9 MFR # 54W202-1406-909 PVP Prep Pad 10% POVIDONE IODINE PAD FIRST AID ANTISEPTIC 1406 each 1406 box 1406 case

NDC 68599-3500-3 McKesson MFR # 54W202-7550-909 PVP Solution USP 10% POVIDONE IODINE FIRST AID ANTISEPTIC NET CONTENTS 0.75 fl oz (22.2 mL) 7550 each 7550 case

NDC 68599-3500-4 McKesson MFR # 54W202-7510-909 PVP Solution USP 10% POVIDONE IODINE FIRST AID ANTISEPTIC NET CONTENTS 0.75 fl oz (22.2 mL) 7510 each 7510 case

NDC 68599-3500-7 McKesson MFR # 307801 PVP Solution USP 10% POVIDONE IODINE FIRST AID ANTISEPTIC NET CONTENTS 2 fl oz (59.1 mL) 801 each 801 case

NDC 68599-3500-8 McKesson MFR # 307811 PVP Solution USP 10% POVIDONE IODINE SPRAY FIRST AID ANTISEPTIC NET CONTENTS 2 fl oz (59.1 mL) 811 each 811 each

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

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Betadine (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Betadine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$874.18
Claims incl. refills
38
Beneficiaries
28
Spend / beneficiary
$31.22
Spend / claim
$23.00
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 McKesson PVP Prep Solution (this brand).

Top reported reactions

Endophthalmitis176
Nausea169
Rash165
Pain158
Drug Hypersensitivity141
Type 2 Diabetes Mellitus129
Pericarditis128

Age at onset

Neonate9
Infant5
Child7
Adolescent3
Adult190
Elderly96

Reporter sex

1,477 reports

Serious outcomes

Death294
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 193 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 ✓ Available
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 McKesson Medical-Surgical. 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 24 bottles (68599-3502-06). 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?
McKesson Medical-Surgical 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.
← 68599-3501-02 · McKesson 68599-4679-09 · McKesson →
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.