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Iodine Tincture Mild Iodine and Sodium Iodide and Alcohol 20 mg/mL; 20.4 mg/mL; 470 mg/mL Liquid, 473 mL — NDC 00395-1213-16 package photo

Iodine Tincture Mild Iodine and Sodium Iodide and Alcohol 20 mg/mL; 20.4 mg/mL; 470 mg/mL Liquid, 473 mL

by Humco Holding Group, Inc. · 473 mL in 1 BOTTLE (0395-1213-16)
NDC 00395-1213-16
🏷️ FDA NDC (as labeled) 0395-1213-16 billing pads the labeler segment with a zero
This package
Contains473 mL Pack sizes2 compare ↓
Also comes in: 30 ml 00395-1213-91
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 0395-1213-16
Product NDC 0395-1213
11-digit billing NDC 00395121316
NCPDP billing unit ML — per mL (volume)
UNII 9679TC07X4, F5WR8N145C, 3K9958V90M
UPC 0303951213919
Application # M003
SPL Set ID 41c0927e-df40-4f83-8fd4-284ec0c02b60
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1979-01-01
Route TOPICAL
Dosage form LIQUID
Substance IODINE; SODIUM IODIDE; ALCOHOL
GPI-14 92200020001510
GPI class Iodine Tincture
GCN Seq No 062671
GCN 98445
HICL code 005095
Ingredient (HICL) Iodine/Sodium Iodide
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 84:04.16.00
AHFS class Astringents, Anti-Infective
FDB label name IODINE 2% MILD TINCTURE
FDB brand name Iodine
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0395-1213-16 — 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 → 00395-1213-16. 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.

🏭 Manufacturer & labeler

LabelerHumco Holding Group, Inc.
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code00395
First marketedJan 1979
Product typeHuman Otc Drug
Portfolio35 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

Label name IODINE 2% MILD TINCTURE Ingredient Iodine/Sodium Iodide
🧪 What is this product?

This is a topical liquid solution containing iodine and sodium iodide, marketed as an over-the-counter monograph drug. Iodine and sodium iodide are typically used in topical products as antiseptics and antimicrobial agents, commonly applied to the skin to help reduce bacteria and other microorganisms on the surface. The product also contains alcohol, which functions as a solvent and preservative in the formulation. This type of product is generally intended for minor wound care and skin antisepsis.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesPurified 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.

💲 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: 30 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
Health Mart Iodine Tincture Mild 20 mg/mL; 20.4 mg/mL; 470 mg/mL 62011-0117-01 Strategic 30 ml $0.072 — FDA listed —
GNP Idoinde Tincture 2% Mild 20 mg/mL; 20.4 mg/mL; 470 mg/mL 24385-0213-10 Amerisource 30 ml $0.073 — Availability likely —
De La Cruz Tincture of Iodine 20 mg/mL; 20.4 mg/mL; 470 mg/mL 24286-1528-07 DLC 30 ml — — FDA listed —
DDM Iodine Tincture Mild 20 mg/mL; 20.4 mg/mL; 470 mg/mL 53943-0213-91 Discount 30 ml — — FDA listed —
Quality Choice Iodine Tincture Mild 20 mg/mL; 20.4 mg/mL; 470 mg/mL 63868-0330-01 Chain 30 ml — — FDA listed —
Harris Teeter Iodine Tincture Mild 20 mg/mL; 20.4 mg/mL; 470 mg/mL 69256-0213-91 Harris 30 ml — — FDA listed —
Iodine Tincture Mild 20 mg/mL; 20.4 mg/mL; 470 mg/mLthis 00395-1213-16 Humco 473 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

🏛️
1979
On the market since
Jan 1979
📍
2026
Currently FDA-listed
47 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
00395-1213-16 You're viewing this 473 mL in 1 BOTTLE (0395-1213-16) 2017-11-14 Active
00395-1213-91 30 mL in 1 BOTTLE (0395-1213-91) 2017-11-14 Active

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

Pack size FAQ

What quantity is in NDC 00395-1213-16?
NDC 00395-1213-16 contains 473 mL — 473 ml in 1 bottle.
What is the difference between NDC 00395-1213-16 and NDC 00395-1213-91?
Both are Iodine Tincture Mild Iodine and Sodium Iodide and Alcohol 20 mg/mL; 20.4 mg/mL; 470 mg/mL Liquid — the drug itself is identical. NDC 00395-1213-16 is the 473 mL package, while NDC 00395-1213-91 is the 30 ml package.
What NDC number is used to bill for this package of Iodine Tincture Mild Iodine and Sodium Iodide and Alcohol 20 mg/mL; 20.4 mg/mL; 470 mg/mL Liquid?
Bill NDC 00395-1213-16 — the 11-digit billing format is 00395121316. 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) ✓ 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 0395-1213-16, 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: 00395-1213-16, written without dashes as 00395121316. 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 00395-1213-16, the first segment (00395) is the labeler code FDA assigned to Humco Holding Group, Inc.; the middle segment (1213) 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 Humco Holding Group, Inc.. 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 30 ml (00395-1213-91). 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?
Humco Holding Group, 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.

📄 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 13 words ▾

Indications First aid to help prevent infection in minor cuts, scrapes and burns

⏱️ Dosage and Administration 28 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 dry first

⚠️ Warnings 123 words ▾

Warnings For external use only . Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Flammable: Keep away from sparks heat and flame St op use and consult doctor if the condition persists or gets worse, or if using for longer than one week When using this product do not use in the eyes. If contact occurs, flush with large amounts of water while lifting upper and lower lids do not apply over large areas of the body Keep out of reach of children .

In case of accidental ingestion, give milk then a starch solution made by mixing two tablespoonfuls of cornstarch or flour to a pint of water. Contact a Poison Control Center immediately.

🧪 Active Ingredient 13 words ▾

Active ingredient Iodine 2%

Active ingredient Sodium Iodide 2.4%

Active ingredient Alcohol 47%

🧪 Inactive Ingredients 4 words ▾

Inactive ingredient Purified Water

🎯 Purpose 12 words ▾

Purpose First Aid Antiseptic

Purpose First Aid Antiseptic

Purpose First Aid Antiseptic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00395-1211-16 · Humco 00395-1249-16 · Humco →
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.