PVP-I Prep Pad Povidone-Iodine 10 mg/mL Swab, 100 packets
by Professional Disposables International, Inc. · 100 PACKET in 1 BOX (10819-3801-2) / .485 mL in 1 PACKET (10819-3801-1)
NDC 10819-3801-02
🏷️ FDA NDC (as labeled)
10819-3801-2
billing pads the package segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Aug 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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)
10819-3801-2
Product NDC
10819-3801
11-digit billing NDC
10819380102
RxCUI
797730
UNII
85H0HZU99M
Application #
505G(a)(3)
SPL Set ID
57b02fbb-a9a6-0b8c-e063-6394a90a44f3
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
2026-06-22
Route
TOPICAL
Dosage form
SWAB
Substance
POVIDONE-IODINE
Why two NDCs?
The FDA registers this code as 10819-3801-2 — 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 → 10819-3801-02. 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.
🏷️ 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
LabelerProfessional Disposables International, Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code10819
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio15 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...
Patient education
Supplement & herbal interactions
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.
💬 Questions about Povidone-Iodine?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII K7O76887AP
A synthetic surfactant (detergent-like substance) used as an emulsifier and solubilizer. It helps mix oil and water-based ingredients together and keeps them blended throughout the medicine's shelf life.
-
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 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, Glycerin, Nonoxynol-10, Purified Water, Sodium Hydroxide
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 system | Per each | Per 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.
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| 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 53329-0125-09 | Medline | 1 applicator | — | — | FDA listed | — |
| Medline 10 mg/mL 53329-0232-30 | Medline | 100 packets | — | — | FDA listed | — |
| Medline 10 mg/mL 53329-0120-05 | Medline | 250 pouches | — | — | FDA listed | — |
| Povidone Iodine Scrub 10 mg/mL 34645-4050-03 | Jianerkang | 6 ml | — | — | FDA listed | — |
| Aplicare 10 mg/mL 52380-0138-01 | Aplicare | 1 applicator | — | — | 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/mLthis 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
🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.
🔬 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 PVP-I Prep Pad (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 36%
Female · 64%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 10819-3801-02 You're viewing this | 100 PACKET in 1 BOX (10819-3801-2) / .485 mL in 1 PACKET (10819-3801-1) | 2026-06-22 | Active |
🧭 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 10819-3801-2, 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: 10819-3801-02, written without dashes as 10819380102. 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 10819-3801-02, the first segment (10819) is the labeler code FDA assigned to Professional Disposables International, Inc.; the middle segment (3801) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Professional Disposables International, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Professional Disposables International, Inc. 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 ▾
Uses A broad spectrum antiseptic for topical application for preparation of skin prior to surgery.
⏱️ Dosage and Administration ▾
Directions Tear at notch Clean the treatment area Remove swab Apply to the operative site prior to surgery Allow to dry
⚠️ Warnings ▾
Warnings For external use only Discontinue use if irritation and redness develop. If condition persists for more than 72 hours or gets worse, consult a healthcare provider.
🧪 Active Ingredient ▾
Active ingredient Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)
🧪 Inactive Ingredients ▾
Inactive ingredients Citric Acid, Glycerin, Nonoxynol-10, Purified Water, Sodium Hydroxide
🎯 Purpose ▾
Purpose Antiseptic
No label section mentions that — try another word, or open the full label on DailyMed below.
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.