NDC 00395-1207-92 — Humco Iodides Tincture Ethyl Alcohol .45 mL/mL

🆔 Identity & classification

FDA NDC (as labeled) 0395-1207-92

Product NDC 0395-1207

11-digit billing NDC 00395120792

NCPDP billing unit ML — per mL (volume)

UNII 3K9958V90M

UPC 0303951207925

Application # M003

SPL Set ID d230e3a2-1cde-44a9-82c3-3dc5474b3a72

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 1998-03-25

Route TOPICAL

Dosage form LIQUID

Substance ALCOHOL

GPI-14 92200020001520

GPI class Iodine Strong

GCN Seq No 060384

GCN 26527

HICL code 033472

Ingredient (HICL) Ammonium And Potassium Iodides

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 84:04.92.00

AHFS class Local Anti-Infectives, Miscellaneous

FDB label name IODIDES TINCTURE

FDB brand name Iodides

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 0395-1207-92 — 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 → 00395-1207-92. 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 marketedMar 1998

Product typeHuman Otc Drug

Portfolio35 products on file

🔎 All NDCs from Humco Holding Group, Inc.

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 IODIDES TINCTURE Ingredient Ammonium And Potassium Iodides

📗 Our plain-language guide HelloPharmacist

Chemically they are related, but hand sanitizer is absolutely not safe to drink — it contains alcohol in concentrations that are toxic if swallowed and often includes other ingredi...
Is the alcohol in hand sanitizer the same as the alcohol in a drink?
Yes — most of these products are specifically labeled 'recommended for repeated use.' Just apply enough to cover your hands and rub until dry. If you notice skin irritation or redn...
Can I use hand sanitizer over and over throughout the day?

📖 Read our full Alcohol guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
UNII 9679TC07X4
Iodine is a chemical element used in medicines as an antiseptic and preservative. It helps prevent bacterial and fungal growth, keeping the product safe and stable during storage.
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.
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.

4 inactive ingredients 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 system	Per mL	Per 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: 473 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Sunmark Iodides Tincture .45 mL/mL 49348-0711-30	Strategic	59 ml	$0.072	—	Availability likely	—
Humco Iodides Tincture .45 mL/mLthis 00395-1207-92	Humco	59 ml	—	—	FDA listed	—
Rite Aid Decolorized Iodine .45 mL/mL 11822-6450-00	Rite	59 ml	—	—	FDA listed	—
Top Care Decolorized Iodine .45 mL/mL 36800-0207-92	TOPCO	59 ml	—	—	FDA listed	—
DDM Decolorized Iodine .45 mL/mL 53943-0207-92	Discount	59 ml	—	—	FDA listed	—
Quality Choice Iodides Tincture .45 mL/mL 63868-0331-02	Chain	60 ml	—	—	FDA listed	—
Decolorized Iodine .45 mL/mL 82645-0909-91	Pharma	30 ml	—	—	FDA listed	—
De La Cruz Decolorized Iodine .45 mL/mL 24286-1529-08	DLC	59 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

🏛️

1998

On the market since

Mar 1998

📍

2026

Currently FDA-listed

28 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.

🔬 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 Humco Iodides Tincture (this brand).

Top reported reactions

Drug Abuse48

Toxicity To Various Agents31

Overdose27

Intentional Overdose19

Poisoning Deliberate19

Suicide Attempt19

Completed Suicide18

Age at onset

Adolescent2

Adult30

Elderly5

Reporter sex

Male · 61%

Female · 39%

Serious outcomes

Hospitalization99

Death74

Life-threatening10

Reports over time (by year) — tap or hover for the count & year

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
00395-1207-16	473 mL in 1 BOTTLE, PLASTIC (0395-1207-16)	2017-10-30	Active
00395-1207-92 You're viewing this	59 mL in 1 BOTTLE, PLASTIC (0395-1207-92)	2017-10-30	Active

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

Pack size FAQ

What quantity is in NDC 00395-1207-92?

NDC 00395-1207-92 contains 59 mL — 59 ml in 1 bottle, plastic.

What is the difference between NDC 00395-1207-92 and NDC 00395-1207-16?

Both are Humco Iodides Tincture Ethyl Alcohol .45 mL/mL Liquid — the drug itself is identical. NDC 00395-1207-92 is the 59 mL package, while NDC 00395-1207-16 is the 473 ml package.

What NDC number is used to bill for this package of Humco Iodides Tincture Ethyl Alcohol .45 mL/mL Liquid?

Bill NDC 00395-1207-92 — the 11-digit billing format is 00395120792. 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 0395-1207-92, 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: 00395-1207-92, written without dashes as 00395120792. 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 00395-1207-92, the first segment (00395) is the labeler code FDA assigned to Humco Holding Group, Inc.; the middle segment (1207) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (92) 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 473 ml (00395-1207-16). 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 ▾

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

⏱️ Dosage and Administration 31 words ▾

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

⚠️ Warnings 5 words ▾

Warnings For external use only.

🧪 Active Ingredient 12 words ▾

Active Ingredients Alcohol 45 % denatured with ammonia, Ammonium and Potassium Iodides.

🧪 Inactive Ingredients 4 words ▾

Inactive Ingredient: Purified Water

🎯 Purpose 2 words ▾

Purpose Antiseptic

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

🔗 Related NDC lookups

🧪 All Ethyl Alcohol NDCsSame ingredient 🏭 All Humco labeler NDCsLabeler code 00395

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Topical Preparations,Antibacterials.

Silver Nitrate 00093-9614-13 Ethyl Alcohol 00363-0876-43 Povidone-Iodine 00395-2325-16 Benzalkonium Chloride 00395-8010-92 Benzethonium Chloride 16864-0440-01 Iodine/Potassium Iodide 38779-0598-05 Hydrocortisone/Iodoquinol 52187-0532-01 Chloroxylenol 61924-0198-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

Humco Iodides Tincture Ethyl Alcohol .45 mL/mL Liquid, 59 mL

🆔 Identity & classification

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

Pack size FAQ

🧭 About this NDC listing & data coverage

Questions about this listing

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups

💊 Related drugs in this class