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Ioddo Iodine .56 g/28g Tincture, 28 g — NDC 84178-005-03 (Billing 84178-0005-03)

by EVI LABS · 28 g in 1 BOTTLE, PLASTIC

This is a package of 28 g of Ioddo Iodine .56 g/28g Tincture from EVI LABS, marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 84178-0005-03
🏷️ FDA NDC (as labeled) 84178-005-03 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 84178-005-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84178 labeler · 005 product · 03 package
Package marketed since
Mar 9, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0729545306391
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84178-005-03
Product NDC 84178-005
11-digit billing NDC 84178000503
RxCUI 311093
UNII 9679TC07X4
UPC 0729545306391
Application # M003
SPL Set ID 4af8552c-1f2b-84ad-e063-6394a90abb62
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-09
Route TOPICAL
Dosage form TINCTURE
Substance IODINE
Quick answers
  • RxCUI (RxNorm): 311093
Why two NDCs? The FDA registers this code as 84178-005-03 — 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 → 84178-0005-03. 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 Iodine products class.

Drug family (ATC) Iodine products
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

🧪 What is this product?

This is an over-the-counter topical tincture containing iodine, marketed under FDA's monograph rules for antiseptic products. Iodine is commonly used as a topical antiseptic to help reduce bacteria and other microorganisms on the skin. The tincture form allows the iodine to be applied directly to minor cuts, scrapes, and other small wounds. This product type has been recognized as safe and effective for these uses under the OTC monograph category.

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
84178-0005-03 You're viewing this Main listing 28 g in 1 BOTTLE, PLASTIC 2026-03-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Foster and Thrive 2% Mild Iodine Tincture 24 mg/mL; 20 mg/mL 70677-1204-01 Strategic 30 ml $0.072 — Availability likely —
Sunmark Iodine 20 mg/mL; 470 mg/mL; 24 mg/mL 49348-0133-27 Strategic 30 ml $0.072 — FDA listed —
Iodine 20 mg/mL 00363-0088-10 Walgreen 30 ml — — FDA listed —
Iodine 20 mg/mL 11344-0880-10 Nice-Pak 30 ml — — FDA listed —
Iodine Tincture 20 mg/mL 30142-0088-10 The 30 ml — — FDA listed —
Iodine 20 mg/mL 41163-0088-10 United 30 ml — — FDA listed —
mild iodine tincture 20 mg/mL; 470 mg/mL; 20.4 mg/mL 59450-0030-36 KROGER 30 ml — — FDA listed —
Salicylic Iodine (Iodo Salicilico) First Aid Antiseptic 20 mg/mL 73635-1220-01 Germa 30 ml — — FDA listed —
Iodine Tincture (IODO) First Aid Antiseptic 20 mg/mL 73635-1221-01 Germa 30 ml — — FDA listed —
Iodo Blanco (Iodine Tincture Decolorized) First Aid Antiseptic 20 mg/mL 73635-1222-01 Germa 30 ml — — FDA listed —
Iodine Tincture 20 mg/mL 76162-0088-10 Topco 30 ml — — FDA listed —
Ioddo Iodine .56 g/28gthis 84178-0005-03 EVI 28 g — — 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
Mar 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.

  • 13.16 g / 28 g UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 0.672 g / 28 g UNII 1C4QK22F9J
    Potassium iodide is an inorganic salt that supplies iodine. In medicines, it acts as a preservative and stabilizer to prevent degradation of active ingredients and extend shelf life.
  • 13.608 g / 28 g 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 statesPurified water, alcohol, and potassium iodine.

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

LabelerEVI LABS
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code84178
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio30 products on file

More NDCs from EVI LABS labeler code 84178

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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Uses First aid to help prevent skin infections, minor cuts, scrapes, and burns.

⏱️ Dosage and Administration 27 words ▾

Directions Clean the affected area. apply a small amount to the area 1 to 3 times daily; may be covered with a sterile bandage; let dry first.

⚠️ Warnings 73 words ▾

Warnings For external use only. Flammable: Keep away from sparks, heat, or flame

Ask a doctor before use If you have deep or puncture wounds, animal bites, or serious burns.

When using this product Do not use in the eyes or apply over large areas of the body. Do not use longer than 1 week unless directed by a doctor.

Stop use and ask a doctor If the conditions persist or get worse.

🧪 Active Ingredient 7 words ▾

Active Ingredients Iodine tinture USP (Iodine 2%)

🧪 Inactive Ingredients 8 words ▾

Inactive Ingredients Purified water, alcohol, and potassium iodine.

🎯 Purpose 4 words ▾

Purpose First Aid Antiseptic

📄 Keep Out of Reach of Children 20 words ▾

keep out of the reach of children If allowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 7 words ▾

Other Information Will stain skin or clothing

📄 Package Label / Principal Display Panel 5 words ▾

Principal Display Panel Iodine Tincture

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 IODDO IODINE (this brand).

Top reported reactions

Drug Hypersensitivity1,135
Nausea454
Fatigue430
Diarrhoea388
Dyspnoea380
Headache360
Arthralgia346

Reporter sex

0 reports
Male · 24%
Female · 76%
Unknown · 1%

Serious outcomes

Hospitalization918
Death490
Life-threatening369
Disabling365
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 231 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 — Not published for this NDC No photo available yet for this listing.
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 EVI LABS. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
EVI LABS 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.
← 84178-0003-01 · EVI 84178-0008-01 · EVI →
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.