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Aplicare Povidone-Iodine 10 mg/mL Swab, 1 applicator — NDC 52380-0138-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Aplicare Povidone-Iodine 10 mg/mL Swab, 1 applicator — NDC 52380-0138-1 (Billing 52380-0138-01)

by Aplicare Products LLC · 1 APPLICATOR in 1 POUCH / 2.4 mL in 1 APPLICATOR

This is a package of 1 applicator of Aplicare Povidone-Iodine 10 mg/mL Swab from Aplicare Products LLC, marketed since Sep 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 52380-0138-01
🏷️ FDA NDC (as labeled) 52380-0138-1 billing pads the package segment with a zero
This package
Contains1 applicator Pack sizes2 compare ↓
Main listing for product 52380-0138 · Also comes in: 50 pouches 52380-0138-2
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 52380-0138-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
52380 labeler · 0138 product · 1 package
Package marketed since
Sep 1, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 5238001381 2
FDA record last changed
Jul 24, 2026
⚠️
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) 52380-0138-1
Product NDC 52380-0138
11-digit billing NDC 52380013801
RxCUI 1300277
UNII 85H0HZU99M
Application # 505G(a)(3)
SPL Set ID 0a48b8ef-f2d6-ed50-e063-6394a90a8ebe
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
  • RxCUI (RxNorm): 1300277
Why two NDCs? The FDA registers this code as 52380-0138-1 — 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 → 52380-0138-01. 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: 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
52380-0138-01 You're viewing this Main listing 1 APPLICATOR in 1 POUCH / 2.4 mL in 1 APPLICATOR 2024-09-01 — Active
52380-0138-02 52380-0138-2 50 POUCH in 1 BOX / 1 APPLICATOR in 1 POUCH / 2.4 mL in 1 APPLICATOR 2024-09-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 applicator — 1 applicator in 1 pouch / 2.4 ml in 1 applicator.
How does this package differ from NDC 52380-0138-02?
Both are Aplicare Povidone-Iodine 10 mg/mL Swab — the drug itself is identical. This page's package is the 1 applicator one, while NDC 52380-0138-02 is the 50 pouches package.
What NDC number is used to bill for this package of Aplicare Povidone-Iodine 10 mg/mL Swab?
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
Aplicare 10 mg/mLthis 52380-0138-01 Aplicare 1 applicator — — FDA listed —
Medline 10 mg/mL 53329-0120-05 Medline 250 pouches — — FDA listed —
Medline 10 mg/mL 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.

🧪 Avoiding an ingredient? See Povidone-Iodine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII 0QDQ2VQ5YJ
    A silicone oil used as a lubricant and anti-foaming agent in tablets and capsules to reduce friction during manufacturing and prevent excessive foam formation in liquid formulations.
  • 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 T4V6TWG28D
    A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
  • UNII U4A966MO25
    A synthetic chemical compound used as an emulsifier and surfactant in medicines. It helps mix oil and water-based ingredients together and improves how the product spreads or dissolves.
  • UNII 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • 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.

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

The official label also statesdisodium phosphate, dodecamethylpentasiloxane, glycerol, hydroxyethylcellulose, nonylphenoxypoly (ethyleneoxy) ethanol-10, 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.

Manufacturer & labeler

LabelerAplicare Products LLC
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code52380
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from Aplicare Products LLC labeler code 52380

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 10 words ▾

Use helps reduce bacteria that potentially can cause skin infection

⏱️ Dosage and Administration 5 words ▾

Directions apply locally as needed

⚠️ Warnings 80 words ▾

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

Stop use and ask a doctor if redness, irritation, swelling or pain develops or persists for more than 72 hours infection occurs

🧪 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

📄 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.

📄 Package Label / Principal Display Panel 6 words ▾

Package label each label box label

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 Aplicare (this brand).

Top reported reactions

Rash1,601
Pemphigus1,589
Pain1,581
Glossodynia1,576
Pericarditis1,549
Joint Swelling1,548
Infusion Related Reaction1,547

Age at onset

Neonate34
Infant5
Child9
Adolescent6
Adult811
Elderly138

Reporter sex

5,760 reports
Male · 17%
Female · 83%
Unknown · 0%

Serious outcomes

Disabling2,794
Death2,644
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,496 161
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) ✓ 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 Aplicare Products LLC. 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 50 pouches (52380-0138-02). 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?
Aplicare Products LLC 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.
← 52380-0013-01 · Aplicare 52380-0205-05 · Aplicare →
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.