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Quality Choice Iodides Tincture Ethyl Alcohol .45 mL/mL Liquid, 60 mL — NDC 63868-0331-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Quality Choice Iodides Tincture Ethyl Alcohol .45 mL/mL Liquid, 60 mL — NDC 63868-331-02 (Billing 63868-0331-02)

by Chain Drug Market Association · 60 mL in 1 BOTTLE, PLASTIC

This is a package of 60 mL of Quality Choice Iodides Tincture Ethyl Alcohol .45 mL/mL Liquid from Chain Drug Market Association, marketed since Mar 1998 and currently FDA-listed. It is this product's only package size.

NDC 63868-0331-02
🏷️ FDA NDC (as labeled) 63868-331-02 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 63868-331-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63868 labeler · 331 product · 02 package
Package marketed since
Dec 12, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
60 mL per package
Barcode (UPC)
0635515954939
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Ethyl Alcohol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 23, 2025 — Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol (Consumer Product Partners, LLC) · FDA recall D-0458-2025
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) 63868-331-02
Product NDC 63868-331
11-digit billing NDC 63868033102
NCPDP billing unit ML — per mL (volume)
UNII 3K9958V90M
UPC 0635515954939
Application # M003
SPL Set ID 71aedfd5-e81f-4b69-b163-527ff1ce30b1
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

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

GPI-14 92200020001510
GPI class QC Iodides
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 QC 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
Why two NDCs? The FDA registers this code as 63868-331-02 — 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 → 63868-0331-02. 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.

Clinical

Label name QC 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 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
63868-0331-02 You're viewing this Main listing 60 mL in 1 BOTTLE, PLASTIC 2017-12-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Decolorized Iodine .48 mL/mL 70000-0399-01 Cardinal 59 ml $0.072 — Availability likely —
Sunmark Iodides Tincture .45 mL/mL 49348-0711-30 Strategic 59 ml $0.072 — Availability likely —
Quality Choice Iodides Tincture .45 mL/mLthis 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 —
Humco Iodides Tincture .45 mL/mL 00395-1207-16 Humco 473 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 —
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.

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.

Manufacturer & labeler

LabelerChain Drug Market Association
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code63868
First marketedMar 1998
Product typeHuman Otc Drug
Portfolio9 products on file

More NDCs from Chain Drug Market Association labeler code 63868

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 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 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

📄 Ask a Doctor Before Use If 16 words ▾

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

📄 When Using This Product 34 words ▾

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.

📄 Stop Use and Ask a Doctor If 23 words ▾

Stop use and ask a doctor if: The condition persists or gets worse, or if using this product for longer than 1 week.

📄 Keep Out of Reach of Children 39 words ▾

Keep out of the reach of children. In case of acidental ingestion give milk, then give a starch solution made by mixing two tablespoonfools of cornstarch or flour to a pint of water. contact a poison Control Center immediately.

📄 Other Information 15 words ▾

Other Information: Will stain skin and clothing. FLAMMABLE: Keep away from spark, heat & flame.

📄 Package Label / Principal Display Panel 7 words ▾

Principal Package Display QCDecolorized.jpg Label 60 ml

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 Quality Choice 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

236 reports

Serious outcomes

Hospitalization99
Life-threatening10
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 16 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 ✓ 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 Chain Drug Market Association. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Chain Drug Market Association 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.
← 63868-0330-01 · Chain 63868-0332-36 · CHAIN →
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.