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DE LA CRUZ GENTIAN VIOLET 1 g/100mL Tincture, 59 mL — NDC 24286-1531-08 package photo

DE LA CRUZ GENTIAN VIOLET 1 g/100mL Tincture, 59 mL

by DLC Laboratories, Inc. · 59 mL in 1 BOTTLE, WITH APPLICATOR (24286-1531-8)
NDC 24286-1531-08
🏷️ FDA NDC (as labeled) 24286-1531-8 billing pads the package segment with a zero
This package
Contains59 mL Pack sizes2 compare ↓
Also comes in: 30 ml 24286-1531-07
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 24286-1531-8
Product NDC 24286-1531
11-digit billing NDC 24286153108
RxCUI 310481
UNII J4Z741D6O5
UPC 0324286153619, 0324286153824, 0324286153718
Application # M003
SPL Set ID d7b4ca59-1bc3-4540-bc0a-2f4b7495a0a7
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-11-01
Route TOPICAL
Dosage form TINCTURE
Substance GENTIAN VIOLET
Why two NDCs? The FDA registers this code as 24286-1531-8 — 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 → 24286-1531-08. 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

LabelerDLC Laboratories, Inc.
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code24286
First marketedNov 2012
Product typeHuman Otc Drug
Portfolio29 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

🧪 What is this product?

De La Cruz Gentian Violet 1 g/100mL Tincture is a topical liquid product containing gentian violet, a dye and antiseptic agent. This over-the-counter monograph drug is typically used on skin to help address minor fungal and bacterial infections. Gentian violet has been traditionally applied to cuts, scrapes, and areas affected by conditions like ringworm or thrush. The tincture form allows the active ingredient to be painted or dabbed directly onto affected areas.

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.

💊 What it looks like

Color purple
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

  • 10 mL / 100 mL 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.
  • 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.

2 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesalcohol, 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.

💲 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
GNP Gentian Violet 1% 10 mg/mL 24385-0003-46 Amerrisource 59 ml $0.050 — Availability likely —
Humco Gentian Violet 1% 10 mg/mL 00395-1003-92 Humco 59 ml — — FDA listed —
Gentian Violet 1 g/100mL 10095-0101-02 World 30 ml — — FDA listed —
De La Cruz Gentian Violet 1 g/100mLthis 24286-1531-08 DLC 59 ml — — FDA listed —
El Valle Gentian Violet 10 mg/mL 55758-0373-01 Pharmadel 30 ml — — FDA listed —
Gentian Violet Anti-Infective 10 mg/mL 73635-1219-01 Germa 29.62 ml — — Discontinued —
Gentian Violet 1% 10 mg/mL 82645-0917-91 Pharma 30 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

🏛️
2012
On the market since
Nov 2012
📍
2026
Currently FDA-listed
14 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 GENTIAN VIOLET — the ingredient across all brands.

Top reported reactions

Condition Aggravated7
Therapeutic Product Effect Incomplete6
Treatment Failure6
Arthralgia5
Arthropathy4
Drug Hypersensitivity4
Drug Resistance4

Age at onset

Adult2

Reporter sex

52 reports
Male · 47%
Female · 53%

Serious outcomes

Hospitalization14
Death3
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
24286-1531-07 30 mL in 1 BOTTLE, WITH APPLICATOR (24286-1531-7) 2017-12-13 Active
24286-1531-08 You're viewing this 59 mL in 1 BOTTLE, WITH APPLICATOR (24286-1531-8) 2021-01-20 Active

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

Pack size FAQ

What quantity is in NDC 24286-1531-08?
NDC 24286-1531-08 contains 59 mL — 59 ml in 1 bottle, with applicator.
What is the difference between NDC 24286-1531-08 and NDC 24286-1531-07?
Both are DE LA CRUZ GENTIAN VIOLET 1 g/100mL Tincture — the drug itself is identical. NDC 24286-1531-08 is the 59 mL package, while NDC 24286-1531-07 is the 30 ml package.
What NDC number is used to bill for this package of DE LA CRUZ GENTIAN VIOLET 1 g/100mL Tincture?
Bill NDC 24286-1531-08 — the 11-digit billing format is 24286153108. 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 24286-1531-8, 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: 24286-1531-08, written without dashes as 24286153108. 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 24286-1531-08, the first segment (24286) is the labeler code FDA assigned to DLC Laboratories, Inc.; the middle segment (1531) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 DLC Laboratories, 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 (24286-1531-07). 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?
DLC Laboratories, 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 14 words ▾

Uses First aid to help prevent infection in minor: cuts scrapes burns insect bites

⏱️ Dosage and Administration 31 words ▾

Directions clean the affected area apply a small amount of this product to the area using the enclosed applicator or a cotton-tipped applicator 1 to 2 times daily do not bandage

⚠️ Warnings 113 words ▾

Warnings For external use only Consult a doctor before use if you have deep or puncture wounds animal bites serious burns When using this product do not use in or near the eyes or over large areas of the body do not apply to an ulcerative lesion as this may result in tattooing of the skin Stop use and consult a doctor if redness, irritation, swelling or pain persists or increases, or if infection or rash occurs symptoms persist for more than 7 days, or clear up and occur again within a few days KEEP OUT OF THE REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center immediately.

📦 Storage and Handling 8 words ▾

Other information medication will stain skin and clothing

🧪 Active Ingredient 5 words ▾

Active ingredient Gentian violet 1%

🧪 Inactive Ingredients 5 words ▾

Inactive ingredients alcohol, 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 ↗
← 24286-1529-08 · DLC 24286-1532-07 · DLC →
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.