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Povidone-Iodine 100 mg/mL Solution, 237 mL — NDC 00904-7639-54 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Povidone-Iodine 100 mg/mL Solution, 237 mL — NDC 0904-7639-54 (Billing 00904-7639-54)

by Major Pharmaceuticals · 237 mL in 1 BOTTLE, PLASTIC

This is a package of 237 mL of Povidone-Iodine 100 mg/mL Solution from Major Pharmaceuticals, marketed since Aug 2026 and currently FDA-listed; retail pharmacies pay about $0.0203 per mL (NADAC). It is this product's only package size.

NDC 00904-7639-54
🏷️ FDA NDC (as labeled) 0904-7639-54 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 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) 0904-7639-54
Product NDC 0904-7639
11-digit billing NDC 00904763954
RxCUI 312564
UNII 85H0HZU99M
UPC 0309047639540
Application # M003
SPL Set ID 59041ca3-a195-5a20-e063-6394a90a2ac9
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 2026-08-14
Route TOPICAL
Dosage form SOLUTION
Substance POVIDONE-IODINE
Quick answers
  • RxCUI (RxNorm): 312564
Why two NDCs? The FDA registers this code as 0904-7639-54 — a 4-4-2 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 labeler segment → 00904-7639-54. 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 mLPer package
Retail pharmacies payNADAC · weekly $0.020 $4.81 / 237 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Sep 2026 $0.020 $0.020
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
00904-7639-54 You're viewing this Main listing 237 mL in 1 BOTTLE, PLASTIC 2026-08-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Povidone-Iodine 100 mg/mLthis 00904-7639-54 Major 237 ml $0.020 — Availability likely —
Povidone Iodine Prep Solution Sterile 100 mg/mL 34645-0013-01 Jianerkang 30 ml — — FDA listed —
MK Povidone-Iodine Swabstick Sterile 100 mg/mL 59050-0257-11 Changzhou 3 pouches — — FDA listed —
Moakang Povidone-Iodine Scrub Winged Sponges 100 mg/mL 59050-0267-00 Changzhou 122.17 ml — — FDA listed —
Maokang Povidone Iodine Swabsticks 3s 100 mg/mL 59050-0271-00 Changzhou 4.9 ml — — FDA listed —
Povidone-Iodine Paint Solution 100 mg/mL 59050-0651-43 Changzhou 89 ml — — FDA listed —
Prep Solution Topical Antiseptic Microbicide 100 mg/mL 67326-0350-04 Degasa 948 ml — — FDA listed —
Konix Povidone Iodine Topical Antiseptic 100 mg/mL 73107-0009-01 TURKUAZ 120 ml — — FDA listed —
Walgreens 10 Povidone-Iodine Solution 100 mg/mL 00363-3736-10 WALGREEN 1 bottle — — FDA listed —
MediChoice PVP Prep Solution 100 mg/mL 39892-0841-01 O&M 118 ml — — FDA listed —
MedPride Prep Solution Topical Antiseptic Microbicide 100 mg/mL 52410-4114-05 Shield 474 ml — — FDA listed —
Amsino 10 Povidone-Iodine Solution 3 4 Fluid Ounce 100 mg/mL 59050-0265-01 Changzhou 22 ml — — FDA listed —
MediChoice PVP Prep 100 mg/mL 39892-0842-01 O&M 237 ml — — FDA listed —
MediChoice PVP Prep 100 mg/mL 39892-0840-01 O&M 59 ml — — FDA listed —
Bd E-Z Scrub 100 mg/mL 17271-0205-03 Becton 11 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 100 mg/mL 59050-0802-00 Changzhou 29.5 ml — — FDA listed —
Betadine 100 mg/mL 67618-0190-01 Atlantis 1 applicator — — FDA listed —
Povidone-Iodine Prep 100 mg/mL 39892-0809-01 O&M 1.5 ml — — FDA listed —
Maokang Povidone-Iodine Paint Solution Antiseptic 100 mg/mL 59050-0561-00 Changzhou 59 ml — — FDA listed —
Maokang Povidone-Iodine Antiseptic 100 mg/mL 59050-0858-01 Changzhou 118 ml — — FDA listed —
Povidone-Iodine 100 mg/mL 70000-0757-01 CARDINAL 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

🏛️
2026
On the market since
Aug 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.

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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 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 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 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 statesCitric Acid, Disodium Phosphate, Glycerin, nonoxynol-9. Sodium Hydroxide and Purified 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

LabelerMajor Pharmaceuticals
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code00904
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio630 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 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Uses First aid antiseptic to prevent infection in minor cuts, scrapes and burns.

⏱️ Dosage and Administration 29 words ▾

Directions Clean the affected area. Apply a small amount on the area 1 to 3 times daily. May be covered with sterile bandage. If bandaged, let it dry first.

⚠️ Warnings 5 words ▾

Warnings For External Use Only

🧪 Active Ingredient 9 words ▾

Active Ingredient Povidone-Iodine 10% (Equivalent to 1% titrable iodine)

🧪 Inactive Ingredients 13 words ▾

Inactive Ingredients Citric Acid, Disodium Phosphate, Glycerin, nonoxynol-9. Sodium Hydroxide and Purified Water.

🎯 Purpose 4 words ▾

Purpose First Aid Antiseptic

📄 Ask a Doctor Before Use If 15 words ▾

Ask a doctor before use if you have deep puncture wounds animal bites serious burns

📄 When Using This Product 38 words ▾

When using this product do not use in eyes use on individuals who are allergic or sensitive to iodine or use for longer than 1 week unless directed by a doctor apply over large areas of the body

📄 Stop Use and Ask a Doctor If 24 words ▾

Stop use and consult a doctor if the condition persists or gets worse irritation and redness develop and persists for more than 72 hours

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately (1-800-222-1222).

📄 Other Information 8 words ▾

Other information store at room temperature, 20-25C (68-77F)

📄 Questions or Comments 4 words ▾

Questions & comments? 1-833-551-0932

📄 Package Label / Principal Display Panel 98 words ▾

Current Label MAJOR NDC 0904-7639-54 Povidone-Iodine Topical Solution povidone-iodine 10% First Aid Antiseptic Helps Prevent Infection in Minor Cuts, Scrapes and Burns COMPARE TO THE ACTIVE INGREDIENT IN BETADINE®† 8 FL OZ (237 mL) *SAFETY SEALED *Warning: Do not use if Tamper Evident Seal is broken or missing. This product is sealed with a foil seal under cap. †This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., owner of the registered trademark Betadine® Distributed by: MAJOR PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Rev.

01/26 M-184 Re-order No. 701457 Major Povidone Iodine 8 13 2026

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.
← 00904-7621-72 · Major 00904-7640-06 · Major →
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.