Home › NDC Lookup › Ingredients › Povidone Iodine › 68599-3500-08
McKesson PVP Prep Solution Povidone-Iodine 1 mg/10mL Liquid, 59.1 mL — NDC 68599-3500-08 package photo

McKesson PVP Prep Solution Povidone-Iodine 1 mg/10mL Liquid, 59.1 mL

by McKesson Medical-Surgical · 59.1 mL in 1 BOTTLE, SPRAY (68599-3500-8)
NDC 68599-3500-08
🏷️ FDA NDC (as labeled) 68599-3500-8 billing pads the package segment with a zero
This package
Contains59.1 mL Pack sizes7 compare ↓
Also comes in: 4 bottles 68599-3500-06 5 ml 68599-3500-09 12 bottles 68599-3500-02 22.2 ml 68599-3500-03 22.2 ml 68599-3500-04 59.1 ml 68599-3500-07
OTC 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 →

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

FDA NDC (as labeled) 68599-3500-8
Product NDC 68599-3500
11-digit billing NDC 68599350008
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 68599-3500-8 — 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 → 68599-3500-08. 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

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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Povidone-iodine is an antiseptic — it kills bacteria on the skin. You'll find it in a lot of different products: surgical scrubs, skin prep solutions and swabs used before procedur...
  • What is povidone-iodine actually used for?
  • The standard topical products are for external skin use only — keep them away from your eyes, ears, and mouth. That said, the 3M Skin and Nasal Antiseptic is specifically labeled f...
  • For first-aid use at home, you should not use povidone-iodine on a wound for more than 7 days unless a doctor or dentist tells you it's okay. If your wound isn't improving after a...
📖 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.

🧪 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.

💲 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: 4 bottles 5 ml 12 bottles 22.2 ml 22.2 ml 59.1 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
McKesson PVP Prep Solution 1 mg/10mL 68599-3502-02 McKesson 36 bottles — — FDA listed —
McKesson PVP Prep Solution 1 mg/10mLthis 68599-3500-08 McKesson 59.1 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

🏛️
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.

📊 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68599-3500-02 12 BOTTLE in 1 CASE (68599-3500-2) / 473 mL in 1 BOTTLE (68599-3500-1) 2016-10-20 Active
68599-3500-06 4 BOTTLE in 1 CASE (68599-3500-6) / 3800 mL in 1 BOTTLE (68599-3500-5) 2016-10-20 Active
68599-3500-03 22.2 mL in 1 POUCH (68599-3500-3) 2026-07-02 Active
68599-3500-04 22.2 mL in 1 POUCH (68599-3500-4) 2026-07-02 Discontinued by firm
68599-3500-07 59.1 mL in 1 BOTTLE (68599-3500-7) 2026-07-02 Active
68599-3500-08 You're viewing this 59.1 mL in 1 BOTTLE, SPRAY (68599-3500-8) 2026-07-02 Active
68599-3500-09 5 mL in 1 PACKET (68599-3500-9) 2026-07-02 Active

Pack size FAQ

What quantity is in NDC 68599-3500-08?
NDC 68599-3500-08 contains 59.1 mL — 59.1 ml in 1 bottle, spray.
What is the difference between NDC 68599-3500-08 and NDC 68599-3500-09?
Both are McKesson PVP Prep Solution Povidone-Iodine 1 mg/10mL Liquid — the drug itself is identical. NDC 68599-3500-08 is the 59.1 mL package, while NDC 68599-3500-09 is the 5 ml package.
What NDC number is used to bill for this package of McKesson PVP Prep Solution Povidone-Iodine 1 mg/10mL Liquid?
Bill NDC 68599-3500-08 — the 11-digit billing format is 68599350008. 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 ✓ 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 FDA registers it as 68599-3500-8, 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: 68599-3500-08, written without dashes as 68599350008. 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 68599-3500-08, the first segment (68599) is the labeler code FDA assigned to McKesson Medical-Surgical; the middle segment (3500) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 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 6 other package presentations of this same product, including 4 bottles (68599-3500-06), 5 ml (68599-3500-09), 12 bottles (68599-3500-02). 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.

📄 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 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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68599-2306-07 · McKesson 68599-3501-02 · 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.