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Aplicare Povidone-Iodine 10 mg/mL Solution, 22.5 mL

by Aplicare Products, LLC · 22.5 mL in 1 PACKET (52380-0001-3)
NDC 52380-0001-03
🏷️ FDA NDC (as labeled) 52380-0001-3 billing pads the package segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 14, 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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through May 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 52380-0001-3
Product NDC 52380-0001
11-digit billing NDC 52380000103
NCPDP billing unit ML — per mL (volume)
Application # part333A
SPL Set ID 6e04f24a-a4ca-4e84-b3b3-7deba0b9cad0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH NOT FINAL
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through May 2025)
Route TOPICAL
Dosage form SOLUTION
Substance POVIDONE-IODINE
GCN Seq No 068305
GCN 31066
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 POVIDONE-IODINE 10% SOLN PKT
FDB brand name Povidone-Iodine
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 52380-0001-3 — 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 → 52380-0001-03. 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

LabelerAplicare Products, LLC
FDA applicationpart333A (OTC MONOGRAPH NOT FINAL)
Labeler code52380
Product typeHuman Otc Drug
Portfolio8 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 POVIDONE-IODINE 10% SOLN PKT 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.

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.
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/mL 53329-0939-04 Medline 118 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 —
Aplicare Povidone-Iodine 10 mg/mLthis 52380-0001-03 Aplicare 22.5 ml — — 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

📍
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 Aplicare Povidone-Iodine (this brand).

Top reported reactions

Endophthalmitis176
Nausea169
Rash165
Pain158
Drug Hypersensitivity141
Type 2 Diabetes Mellitus129
Pericarditis128

Age at onset

Neonate9
Infant5
Child7
Adolescent3
Adult190
Elderly96

Reporter sex

1,477 reports
Male · 36%
Female · 64%
Unknown · 0%

Serious outcomes

Hospitalization543
Death294
Life-threatening272
Disabling196
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 212 0
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 NDCDescription Marketing startStatus
52380-0001-03 You're viewing this 22.5 mL in 1 PACKET (52380-0001-3) 2018-02-15 Discontinued by firm

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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 Not Final". 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 52380-0001-3, 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: 52380-0001-03, written without dashes as 52380000103. 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 52380-0001-03, the first segment (52380) is the labeler code FDA assigned to Aplicare Products, LLC; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
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.

📄 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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 52374-0103-01 · MESSER 52380-0011-01 · 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.