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Medline Povidone-iodine 10 mg/mL Swab, 1 applicator — NDC 53329-125-09 (Billing 53329-0125-09) · Product 53329-125

by Medline Industries, LP · 1 APPLICATOR in 1 POUCH (53329-125-09) / 2.4 mL in 1 APPLICATOR

NDC 53329-125-09 (billing 53329-0125-09) is a package of 1 applicator of Medline Povidone-iodine 10 mg/mL Swab from Medline Industries, LP, marketed since Sep 2024 and currently FDA-listed. It is the main listing for product NDC 53329-125, which comes in 3 package sizes.

NDC 53329-0125-09
🏷️ FDA NDC (as labeled) 53329-125-09 billing pads the product segment with a zero
This package
Contains1 applicator Pack sizes3 compare ↓
Main listing for product 53329-125 · Also comes in: 4 pouches 53329-125-26 50 pouches 53329-125-29
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) 53329-125-09
Product NDC 53329-125
11-digit billing NDC 53329012509
RxCUI 1300277
UNII 85H0HZU99M
Application # 505G(a)(3)
SPL Set ID 1d731a44-f16e-c249-e063-6294a90a39b8
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 2024-09-01
Route TOPICAL
Dosage form SWAB
Substance POVIDONE-IODINE
Quick answers for NDC 53329-125-09
  • RxCUI (RxNorm): 1300277
  • 11-digit billing NDC: 53329012509
Why two NDCs? The FDA registers this code as 53329-125-09 — 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 → 53329-0125-09. 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.

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 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: 4 pouches 50 pouches
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
53329-0125-09 53329-125-09 You're viewing this Main listing 1 APPLICATOR in 1 POUCH (53329-125-09) / 2.4 mL in 1 APPLICATOR 2024-09-01 — Active
53329-0125-26 53329-125-26 4 POUCH in 1 BOX (53329-125-26) / 1 APPLICATOR in 1 POUCH / 10 mL in 1 APPLICATOR 2025-01-01 — Active
53329-0125-29 53329-125-29 50 POUCH in 1 BOX (53329-125-29) / 1 APPLICATOR in 1 POUCH / 10 mL in 1 APPLICATOR 2024-09-01 — Active

Pack size FAQ

What quantity is in NDC 53329-0125-09?
NDC 53329-0125-09 contains 1 applicator — 1 applicator in 1 pouch / 2.4 ml in 1 applicator.
What NDC number is used to bill for this package of Medline Povidone-iodine 10 mg/mL Swab?
Bill NDC 53329-0125-09 — the 11-digit billing format is 53329012509. 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
Aplicare 10 mg/mL 52380-0138-01 Aplicare 1 applicator — — FDA listed —
Medline 10 mg/mL 53329-0120-05 Medline 250 pouches — — FDA listed —
Medline 10 mg/mLthis 53329-0125-09 Medline 1 applicator — — FDA listed —
Prep Pad Sterile 10 g/100g 59050-0456-11 Changzhou 5.5 g — — FDA listed —
Povidone-Iodine Gel Swabstick 10 mg/g 65517-0036-01 Dukal 2.3 g — — FDA listed —
Povidone Iodine Swabsticks 4 Triple 100 mg/g 72838-0360-01 Amsino 3 applicators — — FDA listed —
Proheal Povidone Iodine Prep Pads 1 g/100mL 86173-0002-12 Click 120 packets — — FDA listed —
PHARMA CARE Pro Sterile Prep Swabstick POVIDONE-IODINE 10 mg/mL 71884-0059-01 Enviro 50 pouches — — FDA listed —
Povidone-Iodine Swabsticks Triples 10 mg/mL 53329-0946-02 Medline 3 ml — — FDA listed —
Medline 10 mg/mL 53329-0232-30 Medline 100 packets — — FDA listed —
Povidone Iodine Scrub 10 mg/mL 34645-4050-03 Jianerkang 6 ml — — FDA listed —
Medline 10 mg/mL 53329-0234-09 Medline 1 applicator — — FDA listed —
Povidone-Iodine Prep Pads Medium 10 mg/mL 53329-0941-09 Medline 1 ml — — FDA listed —
Povidone-Iodine Swabsticks Singles 10 mg/mL 53329-0945-09 Medline 1 ml — — FDA listed —
PVP-I Prep Pad 10 mg/mL 10819-3801-02 Professional 100 packets — — 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

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 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

LabelerMedline Industries, LP
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code53329
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio120 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 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

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

⏱️ Dosage and Administration 5 words ▾

Directions swab locally as needed

⚠️ Warnings 54 words ▾

Warnings For external use only Do not use if allergic to iodine in the eyes Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

🧪 Active Ingredient 5 words ▾

Active Ingredient Povidone-iodine USP 10%

🧪 Inactive Ingredients 11 words ▾

Inactive ingredients disodium phosphate, dodecamethylpentasiloxane, glycerol, hydroxyethylcellulose, nonylphenoxypoly (ethyleneoxy) ethanol-10, water

🎯 Purpose 2 words ▾

Purpose Antiseptic

📄 Do Not Use 10 words ▾

Do not use if allergic to iodine in the eyes

📄 Stop Use and Ask a Doctor If 18 words ▾

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

📄 Recent Major Changes 7 words ▾

Major Change Section Update made to Warnings

📄 Package Label / Principal Display Panel 6 words ▾

Package label Each Box 1 Box

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.

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) — 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 53329-125-09, 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: 53329-0125-09, written without dashes as 53329012509. 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 53329-0125-09, the first segment (53329) is the labeler code FDA assigned to Medline Industries, LP; the middle segment (0125) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) 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 2 other package presentations of this same product, including 4 pouches (53329-0125-26), 50 pouches (53329-0125-29). 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.
← 53329-0121-09 · Medline 53329-0140-04 · 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.