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Povidone-Iodine Topical Antiseptic 10 mg/mL Solution, 3785 mL — NDC 53329-0939-25 package photo

Povidone-Iodine Topical Antiseptic 10 mg/mL Solution, 3785 mL

by Medline Industries, LP · 3785 mL in 1 BOTTLE, PLASTIC (53329-939-25)
NDC 53329-0939-25
🏷️ FDA NDC (as labeled) 53329-939-25 billing pads the product segment with a zero
This package
Contains3785 mL Pack sizes7 compare ↓
Also comes in: 59 ml 53329-0939-13 88 ml 53329-0939-69 118 ml 53329-0939-04 237 ml 53329-0939-08 473 ml 53329-0939-06 946 ml 53329-0939-23
OTC On market Non-controlled
🗂️ Data synced Sep 10, 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

🚨
Active recall for this product.
Class III · Aug 19, 2025 — Subpotent drug (Medline Industries, LP) · FDA recall D-0674-2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Povidone-iodine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
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) 53329-939-25
Product NDC 53329-939
11-digit billing NDC 53329093925
RxCUI 312564
UNII 85H0HZU99M
UPC 0080196732237
Application # 505G(a)(3)
SPL Set ID c9036a83-22f5-4a09-b01c-7093d4192c19
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 2007-01-01
Route TOPICAL
Dosage form SOLUTION
Substance POVIDONE-IODINE
GCN Seq No 007233
GCN 45334
HICL code 004265
Ingredient (HICL) Povidone-Iodine
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5B
Therapeutic class — specific (HIC3) Topical Preparations,Antibacterials
AHFS code 84:04.92.00
AHFS class Local Anti-Infectives, Miscellaneous
FDB label name READYPREP PVP 10% SOLUTION
FDB brand name Readyprep Pvp
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 53329-939-25 — 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 → 53329-0939-25. 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 Antiseptic class.

Pharmacologic class Antiseptic
Drug family (ATC) Iodine products, Medicated dressings with antiinfectives, Medicated shampoos
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.

🏭 Manufacturer & labeler

LabelerMedline Industries, LP
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code53329
First marketedJan 2007
Product typeHuman Otc Drug
Portfolio113 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 READYPREP PVP 10% SOLUTION Ingredient Povidone-Iodine
📗 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 48Q180SH9T
    Nonoxynol-9 is a surfactant, a chemical that reduces surface tension. In medicines, it acts as an emulsifier or solubilizer, helping mix ingredients that normally don't combine well, and may also serve as a preservative or antimicrobial agent.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 94255I6E2T
    Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.
  • 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.

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

The official label also statescitric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, 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.

💲 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: 59 ml 88 ml 118 ml 237 ml 473 ml 946 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
povidone iodine 100 mg/mL 00904-1103-09 Major 237 ml $0.014 — Availability likely —
Povidone Iodine .1 g/mL 24385-0053-55 Amerisource 236 ml $0.014 — Availability likely —
Quality Choice Povidone Iodine 100 mg/mL 63868-0230-08 Chain 237 ml $0.017 — FDA listed —
sunmark Povidone-Iodine Topical 1 g/100mL 49348-0622-37 Strategic 237 ml $0.018 — FDA listed —
Leader Povidone-Iodine 10% Topical Solution 10 mg/mL 70000-0060-01 Cardinal 237 ml $0.021 — Availability likely —
Foster and Thrive Povidone-Iodine 100 mg/mL 70677-1208-01 Strategic 237 ml $0.021 — Availability likely —
First Aid Antiseptic 10 mg/mL 00363-0777-34 Walgreen 236 ml — — FDA listed —
Walgreens 10 Povidone-Iodine Solution 100 mg/mL 00363-3736-10 WALGREEN 1 bottle — — FDA listed —
Humco Povidone Iodine 100 mg/mL 00395-2325-16 Humco 473 ml — — FDA listed —
Povidone Iodine 100 mg/mL 00395-9123-16 Humco 473 ml — — FDA listed —
Povidone-Iodine 10 mg/mL 00924-5408-01 Acme 10 vials — — FDA listed —
Povidone Iodine Solution First Aid Antiseptic 10 mg/mL 11344-0050-26 Nice-Pak 118 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 11673-0003-34 Target 236.5 ml — — FDA listed —
Rite Aid Povidone Iodine 100 mg/mL 11822-3775-07 Rite 237 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 11822-9050-01 Rite 237 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 21130-0891-34 Better 236 ml — — FDA listed —
Povidone Iodine Prep Solution Sterile 100 mg/mL 34645-0013-01 Jianerkang 30 ml — — FDA listed —
Povidone Iodine Topical Solution Paint 100 mg/mL 34645-1040-02 Jianerkang 59 ml — — FDA listed —
Povidone Iodine Topical Solution Paint 100 mg/mL 34645-1041-01 Jianerkang 88.5 ml — — FDA listed —
Povidone Iodine 10 mg/mL 34645-4059-06 Jianerkang 59 ml — — FDA listed —
Povidone Iodine 10 mg/mL 34645-4188-06 Jianerkang 88.5 ml — — FDA listed —
Povidone Iodine Prep 10 g/100g 34645-5503-00 Jianerkang 500 patches — — FDA listed —
Povidone Iodine Prep 10 g/100g 34645-5504-00 Jianerkang 250 patches — — FDA listed —
First Aid Antiseptic 10 mg/mL 36800-0011-34 Topco 237 ml — — FDA listed —
HEB Povidone Iodine 100 mg/mL 37808-0232-98 H 237 ml — — FDA listed —
Povidone-Iodine 10 mg/mL 37808-0624-34 H 237 ml — — FDA listed —
Povidone-Iodine Prep 100 mg/mL 39892-0809-01 O&M 1.5 ml — — FDA listed —
MediChoice PVP Prep 100 mg/mL 39892-0840-01 O&M 59 ml — — FDA listed —
MediChoice PVP Prep Solution 100 mg/mL 39892-0841-01 O&M 118 ml — — FDA listed —
MediChoice PVP Prep 100 mg/mL 39892-0842-01 O&M 237 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 41250-0720-34 Meijer, 237 ml — — FDA listed —
Publix Povidone Iodine 100 mg/mL 41415-0325-98 Publix 237 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 49035-0050-34 Walmart 237 ml — — FDA listed —
Povidone-Iodine 10 mg/mL 50332-0056-01 HART 10 vials — — FDA listed —
Aplicare Povidone-Iodine 10 mg/mL 52380-0011-01 Aplicare 30 ml — — Discontinued —
Aplicare Povidone-Iodine 10 mg/mL 52380-1905-00 Aplicare 60 ml — — FDA listed —
Aplicare Povidone-Iodine 10 mg/mL 52380-2801-08 Aplicare 59 ml — — FDA listed —
Aplicare Povidone-Iodine 10 mg/mL 52380-4801-08 Aplicare 118 ml — — FDA listed —
MedPride Prep Solution Topical Antiseptic Microbicide 100 mg/mL 52410-4114-05 Shield 474 ml — — FDA listed —
Povidone-Iodine Topical Antiseptic 10 mg/mLthis 53329-0939-25 Medline 3785 ml — — FDA listed —
DDM Povidone Iodine 100 mg/mL 53943-0325-98 Discount 237 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 55319-0700-26 Family 118 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 55910-0001-26 Old 118 ml — — FDA listed —
Amsino 10 Povidone-Iodine Solution 3 4 Fluid Ounce 100 mg/mL 59050-0265-01 Changzhou 22 ml — — FDA listed —
Moakang Povidone-Iodine Scrub Winged Sponges 100 mg/mL 59050-0267-00 Changzhou 122.17 ml — — FDA listed —
Maokang Medical 10 Povidone Iodine 100 mg/mL 59050-0272-10 Changzhou 2.12 ml — — FDA listed —
Povidone-Iodine Solution Sterile 100 mg/mL 59050-0554-11 Changzhou 30 ml — — FDA listed —
Maokang Povidone-Iodine Paint Solution Antiseptic 100 mg/mL 59050-0561-00 Changzhou 59 ml — — FDA listed —
Povidone-Iodine Paint Solution 100 mg/mL 59050-0651-43 Changzhou 89 ml — — FDA listed —
Maokang Povidone Iodine 100 mg/mL 59050-0802-00 Changzhou 29.5 ml — — FDA listed —
Maokang Povidone-Iodine Antiseptic 100 mg/mL 59050-0858-01 Changzhou 118 ml — — FDA listed —
Lights Povidone Iodine Solution 1.18 g/118mL 61333-0201-01 Lights 118 ml — — FDA listed —
Lights Povidone Iodine Solution 1.18 g/118mL 61333-0202-01 Lights 118 ml — — FDA listed —
Lights Povindone Iodine Swabstick 1 g/100g 61333-0204-01 Lights 4.3 g — — FDA listed —
PVP-I Pouch foil-foil 1 g/100mL 65517-0035-01 Dukal 500 pouches — — FDA listed —
Prep Solution Topical Antiseptic Microbicide 100 mg/mL 67326-0350-04 Degasa 948 ml — — FDA listed —
Betadine Solution 10 mg/mL 67618-0150-01 Atlantis 3780 ml — — FDA listed —
Dynarex Povidone Iodine Prep Solution 10 mg/mL 67777-0141-31 Dynarex 48 bottles — — FDA listed —
Premier Value Povidone Iodine 100 mg/mL 68016-0415-00 Chain 237 ml — — FDA listed —
Povidone Iodine Prep 10 g/100mL 68786-0010-08 Sion 236 ml — — FDA listed —
Povidone Iodine Prep 1 g/100mL 68786-0132-01 Sion 500 packets — — FDA listed —
povidone-iodine 10% 10 mg/mL 69452-0483-93 BIONPHARMA 237 ml — — FDA listed —
CliniClean Povidone-Iodine Solution Antiseptic 100 mg/g 69464-0801-75 HR 23 g — — FDA listed —
CVS Povidone-Iodine 100 mg/mL 69842-0325-98 CVS 237 ml — — FDA listed —
Povidone-Iodine 100 mg/mL 70000-0757-01 CARDINAL 237 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 72288-0450-26 Amazon.com 118 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 72476-0050-34 Retail 237 ml — — FDA listed —
Konix Povidone Iodine Topical Antiseptic 100 mg/mL 73107-0009-01 TURKUAZ 120 ml — — FDA listed —
equate First Aid Antiseptic 1 g/100mL 79903-0230-08 Walmart 237 ml — — FDA listed —
Freskaro Povidone Iodine 100 mg/mL 82645-0325-16 Pharma 473 ml — — FDA listed —
Povidone Iodine 100 mg/mL 82645-0907-16 Pharma 473 ml — — FDA listed —
ADI Medical PVP-I Pouch, Foil 10 g/100g 83645-0550-11 Asia 50 pouches — — FDA listed —
sterile 10 g/100g 83645-0552-11 Asia 22.5 g — — FDA listed —
Povidone Iodine 10% 100 mg/mL 85786-0702-08 Farmacias 237 ml — — FDA listed —
Proheal Povidone Iodine 1 g/100mL 86173-0004-04 Click 118 ml — — FDA listed —
Povidone-Iodine 10 mg/mL 46414-7777-02 James 100 vials — — FDA listed —
Betadine Solution Swabsticks 10 mg/mL 67618-0153-01 Atlantis 1 applicator — — Discontinued —
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

🏛️
2007
On the market since
Jan 2007
📍
2026
Currently FDA-listed
19 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
53329-0939-04 118 mL in 1 BOTTLE, PLASTIC (53329-939-04) 2017-10-27 Active
53329-0939-06 473 mL in 1 BOTTLE, PLASTIC (53329-939-06) 2007-01-01 Active
53329-0939-08 237 mL in 1 BOTTLE, PLASTIC (53329-939-08) 2007-01-01 Active
53329-0939-13 59 mL in 1 BOTTLE, PLASTIC (53329-939-13) 2007-01-01 Active
53329-0939-23 946 mL in 1 BOTTLE, PLASTIC (53329-939-23) 2007-01-01 Active
53329-0939-25 You're viewing this 3785 mL in 1 BOTTLE, PLASTIC (53329-939-25) 2007-01-01 Active
53329-0939-69 88 mL in 1 BOTTLE, PLASTIC (53329-939-69) 2007-01-01 Active

You're viewing the largest of 7 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 53329-0939-25?
NDC 53329-0939-25 contains 3785 mL — 3785 ml in 1 bottle, plastic.
What is the difference between NDC 53329-0939-25 and NDC 53329-0939-13?
Both are Povidone-Iodine Topical Antiseptic 10 mg/mL Solution — the drug itself is identical. NDC 53329-0939-25 is the 3785 mL package, while NDC 53329-0939-13 is the 59 ml package.
What NDC number is used to bill for this package of Povidone-Iodine Topical Antiseptic 10 mg/mL Solution?
Bill NDC 53329-0939-25 — the 11-digit billing format is 53329093925. 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) ✓ 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 53329-939-25, 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: 53329-0939-25, written without dashes as 53329093925. 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 53329-0939-25, the first segment (53329) is the labeler code FDA assigned to Medline Industries, LP; the middle segment (0939) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (25) 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 Medline Industries, LP. 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 59 ml (53329-0939-13), 88 ml (53329-0939-69), 118 ml (53329-0939-04). 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?
Medline Industries, LP 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 33 words ▾

Uses healthcare antiseptic for preparation of the skin prior to surgery first aid antiseptic to help prevent infection in minor cuts, scrapes and burns single use when used for patient preoperative skin preparation

⏱️ Dosage and Administration 53 words ▾

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

⚠️ Warnings 86 words ▾

Warnings For external use only. Do not use in the eyes longer than 1 week unless directed by a doctor on individuals who are allergic or sensitive to iodine or apply over large areas of the body Stop use and ask a doctor if irritation and redness develop condition persists for more than 72 hours in case of deep or puncture wounds, animal bites or serious burns Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 8 words ▾

Other information protect from freezing, avoid excessive heat

🧪 Active Ingredient 10 words ▾

Active ingredient Povidone Iodine 10% (equivalent to 1% available iodine)

🧪 Inactive Ingredients 10 words ▾

Inactive ingredients citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

🎯 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 ↗
← 53329-0938-04 · Medline 53329-0941-09 · Medline →
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.