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Aplicare Povidone-Iodine 10 mg/mL Solution, 90 mL — NDC 52380-1905-03 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 Solution, 90 mL — NDC 52380-1905-3 (Billing 52380-1905-03)

by Aplicare Products, LLC · 90 mL in 1 BOTTLE

This is a package of 90 mL of Aplicare Povidone-Iodine 10 mg/mL Solution from Aplicare Products, LLC, marketed since Sep 1998 and currently FDA-listed.

NDC 52380-1905-03
🏷️ FDA NDC (as labeled) 52380-1905-3 billing pads the package segment with a zero
This package
Contains90 mL Pack sizes2 compare ↓
Product page 52380-1905-00 Also comes in: 60 ml 52380-1905-0
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 17, 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) 52380-1905-3
Product NDC 52380-1905
11-digit billing NDC 52380190503
RxCUI 312564, 617973
UNII 85H0HZU99M
Application # 505G(a)(3)
SPL Set ID 7302a2f8-a600-4200-bc4e-309e4c190fe5
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 1998-09-01
Route TOPICAL
Dosage form SOLUTION
Substance POVIDONE-IODINE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 068306
GCN 31067
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% SOLUTION
FDB brand name Povidone-Iodine
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 068306
  • GCN: 31067
  • HICL (First Databank): 004265
  • AHFS class code: 84:04.92.00
  • RxCUI (RxNorm): 312564
Why two NDCs? The FDA registers this code as 52380-1905-3 — 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 → 52380-1905-03. 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.

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

Label name POVIDONE-IODINE 10% SOLUTION Ingredient Povidone-Iodine
📗 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 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: 60 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
52380-1905-00 52380-1905-0 Main listing 60 mL in 1 BOTTLE, SPRAY 1998-09-01 — Active
52380-1905-03 You're viewing this 90 mL in 1 BOTTLE 1998-09-01 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 90 mL — 90 ml in 1 bottle.
How does this package differ from NDC 52380-1905-00?
Both are Aplicare Povidone-Iodine 10 mg/mL Solution — the drug itself is identical. This page's package is the 90 mL one, while NDC 52380-1905-00 is the 60 ml package.
What NDC number is used to bill for this package of Aplicare Povidone-Iodine 10 mg/mL Solution?
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
First Aid Antiseptic 10 mg/mL 49035-0050-34 Walmart 237 ml — — FDA listed —
Aplicare Povidone-Iodine 10 mg/mL 52380-0011-01 Aplicare 30 ml — — Discontinued —
Aplicare Povidone-Iodine 10 mg/mL 52380-4801-08 Aplicare 118 ml — — FDA listed —
Povidone-Iodine 10 mg/mL 46414-7777-02 James 100 vials — — FDA listed —
Aplicare Povidone-Iodine 10 mg/mLthis 52380-1905-03 Aplicare 90 ml — — FDA listed —
Betadine Solution 10 mg/mL 67618-0150-01 Atlantis 3780 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 72476-0050-34 Retail 237 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 36800-0011-34 Topco 237 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 55319-0700-26 Family 118 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 00363-0777-34 Walgreen 236 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 72288-0450-26 Amazon.com 118 ml — — FDA listed —
Povidone-Iodine 10 mg/mL 00924-5408-01 Acme 10 vials — — FDA listed —
Povidone-Iodine 10 mg/mL 37808-0624-34 H 237 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 11822-9050-01 Rite 237 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 55910-0001-26 Old 118 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 41250-0720-34 Meijer, 237 ml — — FDA listed —
Povidone-Iodine Topical Antiseptic 10 mg/mL 53329-0939-04 Medline 118 ml — — FDA listed —
Betadine Solution Swabsticks 10 mg/mL 67618-0153-01 Atlantis 1 applicator — — Discontinued —
Povidone-Iodine 10 mg/mL 50332-0056-01 HART 10 vials — — FDA listed —
Aplicare Povidone-Iodine 10 mg/mL 52380-2801-08 Aplicare 59 ml — — 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 21130-0891-34 Better 236 ml — — FDA listed —
First Aid Antiseptic 10 mg/mL 11673-0003-34 Target 236.5 ml — — FDA listed —
povidone-iodine 10% 10 mg/mL 69452-0483-93 BIONPHARMA 237 ml — — 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

🏛️
1998
On the market since
Sep 1998
📍
2026
Currently FDA-listed
28 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.

💡 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 GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • 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.

Manufacturer & labeler

LabelerAplicare Products, LLC
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code52380
First marketedSep 1998
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.

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 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Uses antiseptic skin preparation single use when used for patient preoperative skin preparation

⏱️ Dosage and Administration 5 words ▾

Directions apply topically as needed

⚠️ Warnings 83 words ▾

Warnings For external use only Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation. Do not use in the eyes on individuals allergic or sensitive to iodine Ask a doctor before use if injuries are deep or puncture wounds serious burns Stop use and ask a doctor if infection occurs redness, irritation, swelling or pain persists or increases Keep out of reach of children.

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

🧪 Active Ingredient 9 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

📄 Do Not Use 13 words ▾

Do not use in the eyes on individuals allergic or sensitive to iodine

📄 Ask a Doctor Before Use If 14 words ▾

Ask a doctor before use if injuries are deep or puncture wounds serious burns

📄 Stop Use and Ask a Doctor If 17 words ▾

Stop use and ask a doctor if infection occurs redness, irritation, swelling or pain persists or increases

📄 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.

📄 Other Information 14 words ▾

Other information not made with natural rubber latex for hospital or professional use only

📄 Questions or Comments 5 words ▾

Questions or comments? www.medline.com 1-800-Medline

📄 Recent Major Changes 20 words ▾

Recent Major Changes Update to indications and usage section July 2026 Update to indications and usage section September 2, 2026

📄 Package Label / Principal Display Panel 3 words ▾

Package Label Each

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 Povidone-Iodine (this brand).

Top reported reactions

Endophthalmitis176
Nausea169
Rash165
Pain158
Drug Hypersensitivity141
Type 2 Diabetes Mellitus129
Pericarditis128

Reporter sex

1,477 reports

Serious outcomes

Death294
Life-threatening272
Disabling196
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 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.

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 60 ml (52380-1905-00). 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.
← 52380-1013-03 · Aplicare 52380-2801-08 · 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.