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Povidone Iodine 100 mg/mL Liquid, 473 mL — NDC 82645-0907-16 package photo

Povidone Iodine 100 mg/mL Liquid, 473 mL

by Pharma Nobis, LLC · 473 mL in 1 BOTTLE, PLASTIC (82645-907-16)
NDC 82645-0907-16
🏷️ FDA NDC (as labeled) 82645-907-16 billing pads the product segment with a zero
This package
Contains473 mL Pack sizes3 compare ↓
Also comes in: 177 ml 82645-0907-96 237 ml 82645-0907-98
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 82645-907-16
Product NDC 82645-907
11-digit billing NDC 82645090716
RxCUI 312564
UNII 85H0HZU99M
UPC 0041220676088, 0367618150184, 0635515992306, 0087701408960 +10 more
Application # M003
SPL Set ID e42eee1b-3539-fb17-e053-2995a90af61d
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 2008-01-01
Route TOPICAL
Dosage form LIQUID
Substance POVIDONE-IODINE
Why two NDCs? The FDA registers this code as 82645-907-16 — a 5-3-2 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 product segment → 82645-0907-16. 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

LabelerPharma Nobis, LLC
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code82645
First marketedJan 2008
Product typeHuman Otc Drug
Portfolio40 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...
📖 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.
Try another pack size: 177 ml 237 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.

🔁 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/mLthis 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 —
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

🏛️
2008
On the market since
Jan 2008
📍
2026
Currently FDA-listed
18 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
82645-0907-16 You're viewing this 473 mL in 1 BOTTLE, PLASTIC (82645-907-16) 2017-11-14 Active
82645-0907-96 177 mL in 1 BOTTLE, PLASTIC (82645-907-96) 2022-12-19 Active
82645-0907-98 237 mL in 1 BOTTLE, PLASTIC (82645-907-98) 2017-11-14 Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 82645-0907-16?
NDC 82645-0907-16 contains 473 mL — 473 ml in 1 bottle, plastic.
What is the difference between NDC 82645-0907-16 and NDC 82645-0907-96?
Both are Povidone Iodine 100 mg/mL Liquid — the drug itself is identical. NDC 82645-0907-16 is the 473 mL package, while NDC 82645-0907-96 is the 177 ml package.
What NDC number is used to bill for this package of Povidone Iodine 100 mg/mL Liquid?
Bill NDC 82645-0907-16 — the 11-digit billing format is 82645090716. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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) — 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 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 82645-907-16, 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: 82645-0907-16, written without dashes as 82645090716. 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 82645-0907-16, the first segment (82645) is the labeler code FDA assigned to Pharma Nobis, LLC; the middle segment (0907) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) 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 Pharma Nobis, 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 2 other package presentations of this same product, including 177 ml (82645-0907-96), 237 ml (82645-0907-98). 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?
Pharma Nobis, 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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 12 words ▾

Use First aid antiseptic to prevent infection in minor cuts 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 badaged, let it dry first.

⚠️ Warnings 5 words ▾

Warnings For External Use Only

🧪 Active Ingredient 7 words ▾

Active Ingredient Povidone-Iodine 10% (1% available 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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82645-0906-16 · Pharma 82645-0908-98 · Pharma →
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.