Home › NDC Lookup › Ingredients › Alcohol Liquid › 70000-0399-01
Leader Decolorized Iodine Alcohol Liquid .48 mL/mL Liquid, 59 mL — NDC 70000-0399-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Leader Decolorized Iodine Alcohol Liquid .48 mL/mL Liquid, 59 mL — NDC 70000-0399-1 (Billing 70000-0399-01)

by Cardinal Health, 110 dba Leader · 59 mL in 1 CONTAINER

This is a package of 59 mL of Leader Decolorized Iodine Alcohol Liquid .48 mL/mL Liquid from Cardinal Health, 110 dba Leader, marketed since Feb 2019 and currently FDA-listed; retail pharmacies pay about $0.0722 per mL (NADAC). It is this product's only package size.

NDC 70000-0399-01
🏷️ FDA NDC (as labeled) 70000-0399-1 billing pads the package 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 70000-0399-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70000 labeler · 0399 product · 1 package
Package marketed since
Feb 18, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
59 mL per package
Barcode (UPC-A, from the NDC)
3 7000003991 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0399-1
Product NDC 70000-0399
11-digit billing NDC 70000039901
NCPDP billing unit ML — per mL (volume)
RxCUI 1804178
UNII 3K9958V90M
Application # M003
SPL Set ID 822f6f28-956f-dd82-e053-2991aa0ae752
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-02-18
Route TOPICAL
Dosage form LIQUID
Substance ALCOHOL

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 92200020001510
GPI class Decolorized Iodine
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
Quick answers
  • GSN (GCN sequence number): 060384
  • GCN: 26527
  • GPI-14 (Medi-Span): 92200020001510
  • HICL (First Databank): 033472
  • AHFS class code: 84:04.92.00
  • RxCUI (RxNorm): 1804178
Why two NDCs? The FDA registers this code as 70000-0399-1 — a 5-4-1 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 package segment → 70000-0399-01. 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 Other antiseptics and disinfectants class.

Drug family (ATC) Other antiseptics and disinfectants, Antidotes, Nerve depressants
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

Label name IODIDES TINCTURE Ingredient Ammonium And Potassium Iodides
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Hand sanitizers and wipes help reduce bacteria on your skin, and alcohol pads prepare skin before an injection. A separate injected form is used by heart...
  • Most directions say to cover all surfaces of your hands and rub until dry. Sprays and wipes follow similar steps. Check your product's label, since directions differ a bit between...
  • Children under 6 should use hand sanitizer only with adult supervision to avoid swallowing. Keep all products out of reach of children. If someone swallows it, get medical help or...
  • Stop using it and ask a doctor if you get irritation and redness, or if your condition lasts more than 72 hours. Avoid broken skin and keep it out of your eyes. If it gets in your...
📖 Read our full Alcohol 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 $0.072 $4.26 / 59 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Nov 2021 Oct 2022 Mar 2026 Sep 2026 $0.075 $0.068
▲ Up 6% over the last 19 months.
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
70000-0399-01 You're viewing this Main listing 59 mL in 1 CONTAINER 2019-02-18 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Decolorized Iodine .48 mL/mLthis 70000-0399-01 Cardinal 59 ml $0.072 — Availability likely —
Quality Choice Iodides Tincture .45 mL/mL 63868-0331-02 Chain 60 ml — — FDA listed —
CVS Decolorized Iodine .48 mL/mL 69842-0207-92 CVS 59 ml — — FDA listed —
Foster and Thrive Decolorized Iodine .48 mL/mL 70677-1202-01 Strategic 59 ml — — FDA listed —
Freskaro Decolorized Iodine .48 mL/mL 82645-0207-92 Pharma 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

🏛️
2019
On the market since
Feb 2019
📍
2026
Currently FDA-listed
7 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.

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 Alcohol 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 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 statesAmmonium Hydroxide Iodine Potassium Iodide Purified 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.

Manufacturer & labeler

LabelerCardinal Health, 110 dba Leader
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedFeb 2019
Product typeHuman Otc Drug
Portfolio34 products on file

More NDCs from Cardinal Health, 110 dba Leader labeler code 70000

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

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

⏱️ Dosage and Administration 28 words ▾

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

⚠️ Warnings 37 words ▾

For External Use Only. When using this product: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns consult a doctor.

🧪 Active Ingredient 3 words ▾

Ethyl Alcohol 48%

🧪 Inactive Ingredients 7 words ▾

Ammonium Hydroxide Iodine Potassium Iodide Purified Water

🎯 Purpose 3 words ▾

First Aid Antiseptic

📄 Keep Out of Reach of Children 27 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Soap will deactivate the effects of this product.

📄 Package Label / Principal Display Panel 1 words ▾

ss

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0398-01 · Cardinal 70000-0400-01 · Cardinal →
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.