Home › NDC Lookup › Ingredients › Povidone Iodine › 67618-0192-03
Betadine POVIDONE-IODINE 5 mg/mL Spray, 88.7 mL — NDC 67618-0192-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Betadine POVIDONE-IODINE 5 mg/mL Spray, 88.7 mL — NDC 67618-192-03 (Billing 67618-0192-03)

by Atlantis Consumer Healthcare, Inc. · 88.7 mL in 1 BOTTLE

This is a package of 88.7 mL of Betadine POVIDONE-IODINE 5 mg/mL Spray from Atlantis Consumer Healthcare, Inc., marketed since Jan 2025 and currently FDA-listed. It is this product's only package size.

NDC 67618-0192-03
🏷️ FDA NDC (as labeled) 67618-192-03 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 67618-192-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
67618 labeler · 192 product · 03 package
Package marketed since
Jan 2, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0367618160039
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) 67618-192-03
Product NDC 67618-192
11-digit billing NDC 67618019203
RxCUI 108204, 238850
UNII 85H0HZU99M
UPC 0367618160039
Application # M003
SPL Set ID 00002127-02bc-4c66-b0c3-ca29d8224afc
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 2025-01-02
Route TOPICAL
Dosage form SPRAY
Substance POVIDONE-IODINE
Quick answers
  • RxCUI (RxNorm): 108204
Why two NDCs? The FDA registers this code as 67618-192-03 — 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 → 67618-0192-03. 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

📗 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.
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
67618-0192-03 You're viewing this Main listing 88.7 mL in 1 BOTTLE 2025-01-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Betadine 5 mg/mL 67618-0160-03 Atlantis 89 ml $0.070 — Discontinued —
Betadine 5 mg/mLthis 67618-0192-03 Atlantis 88.7 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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year 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 H3ZIY6WP1R
    A synthetic surfactant made from plant-derived oils and ethylene oxide. It helps dissolve and mix oil-based and water-based ingredients together in liquid formulations.
  • 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.

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

The official label also statespareth 25-9, purified water, sodium hydroxide Questions? 1-833-288-2684

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

LabelerAtlantis Consumer Healthcare, Inc.
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code67618
First marketedJan 2025
Product typeHuman Otc Drug
Portfolio17 products on file

More NDCs from Atlantis Consumer Healthcare, Inc. labeler code 67618

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 📦 Storage and Handling 🧪 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

Uses First aid to help prevent infection in minor cuts scrapes burns

⏱️ Dosage and Administration 32 words ▾

Directions clean the affected area spray a small amount of the product on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first

⚠️ Warnings 5 words ▾

Warnings For external use only

📦 Storage and Handling 14 words ▾

Other information store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) Do Not Freeze

🧪 Active Ingredient 9 words ▾

Drug Facts Active ingredients Povidone-iodine, 5% (0.5% available iodine)

🧪 Inactive Ingredients 10 words ▾

Inactive ingredients pareth 25-9, purified water, sodium hydroxide Questions? 1-833-288-2684

🎯 Purpose 4 words ▾

Purpose First aid Antiseptic

📄 Do Not Use 25 words ▾

Do not use in the eyes over large areas of the body If you are allergic to povidone-iodine or any other ingredients in this preparation

📄 Ask a Doctor Before Use If 16 words ▾

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

📄 Stop Use and Ask a Doctor If 24 words ▾

Stop use and ask a doctor if the condition persists or gets worse you need to use this product for more than 1 week

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 106 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NEW LOOK! HOSPITAL TRUSTED SINCE 1955 BETADINE ® ANTISEPTIC 5% POVIDONE-IODINE First Aid Antiseptic Spray √ Ideal for Minor Cuts, Wounds, Scrapes & Burns √ Kills 99.9% of Germs * To Prevent Infection √ Works in Seconds t √ No Stinging or Burning 3 fl oz (88.7mL) Helps protect against skin infection Golden brown color indicates area treated Visit www.Betadine.com for more information * commonlly associated with skin infections. t based on in vitro lab data. Dist. by: Atlantis Consumer Healthcare Inc.

Bridgewater, NJ 08807 USA ©2024 Atlantis Consumer Healthcare Inc. Betadine is a registered trademark of Atlantis Consumer Healthcare Inc. A0324

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 — 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.

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 Atlantis Consumer Healthcare, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Atlantis Consumer Healthcare, Inc. 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.
← 67618-0190-01 · Atlantis 67618-0200-04 · Atlantis →
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.