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El Valle Gentian Violet Gentian Violet 1% 10 mg/mL Liquid, 30 mL — NDC 55758-0373-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

El Valle Gentian Violet Gentian Violet 1% 10 mg/mL Liquid, 30 mL — NDC 55758-373-01 (Billing 55758-0373-01)

by Pharmadel LLC · 30 mL in 1 BOTTLE, PLASTIC

This is a package of 30 mL of El Valle Gentian Violet Gentian Violet 1% 10 mg/mL Liquid from Pharmadel LLC, marketed since May 2023 and currently FDA-listed. It is this product's only package size.

NDC 55758-0373-01
🏷️ FDA NDC (as labeled) 55758-373-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 55758-373-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55758 labeler · 373 product · 01 package
Package marketed since
May 31, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5575837301 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55758-373-01
Product NDC 55758-373
11-digit billing NDC 55758037301
RxCUI 310481
UNII J4Z741D6O5
Application # M004
SPL Set ID fc75aa2b-0e6e-e2f7-e053-6294a90ac01f
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-31
Route TOPICAL
Dosage form LIQUID
Substance GENTIAN VIOLET
Quick answers
  • RxCUI (RxNorm): 310481
Why two NDCs? The FDA registers this code as 55758-373-01 — 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 → 55758-0373-01. 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.

Clinical

🧪 What is this product?

This is a topical liquid solution containing gentian violet, an over-the-counter monograph drug product. Gentian violet is an antimicrobial dye that is typically used on the skin to help treat minor fungal and bacterial infections, including conditions like ringworm, athlete's foot, and minor cuts or wounds. The 1% concentration (10 mg/mL) is a common strength for topical application. As an OTC monograph product, it is marketed under established FDA guidelines for this drug category.

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
55758-0373-01 You're viewing this Main listing 30 mL in 1 BOTTLE, PLASTIC 2023-05-31 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
GNP Gentian Violet 1% 10 mg/mL 24385-0003-46 Amerrisource 59 ml $0.049 — 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/100mL 24286-1531-07 DLC 30 ml — — FDA listed —
El Valle Gentian Violet 10 mg/mLthis 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

🏛️
2023
On the market since
May 2023
📍
2026
Currently FDA-listed
3 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 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, 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

LabelerPharmadel LLC
FDA applicationM004 (OTC MONOGRAPH DRUG)
Labeler code55758
First marketedMay 2023
Product typeHuman Otc Drug
Portfolio67 products on file

More NDCs from Pharmadel LLC labeler code 55758

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

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

⏱️ Dosage and Administration 26 words ▾

Directions clean the affected area apply a small amount directly to the affected area 1 to 3 times a day may cover area with sterile bandage

⚠️ Warnings 67 words ▾

Warnings FOR EXTERNAL USE ONLY. Do not use longer than 1 week, unless directed by a doctor in the eyes Ask a doctor before use if you have a deep or puncture wounds serious burns animal bites Stop use and consult a doctor if conditions persist or gets worse Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center immediately.

🧪 Active Ingredient 17 words ▾

Active Ingredient & Purpose Gentian Violet 1% Active ingredient Purpose Gentian Violet 1% ............................. First aid antespetic

🧪 Inactive Ingredients 4 words ▾

Inactive ingredients alcohol, water

🎯 Purpose 10 words ▾

Active ingredient Purpose Gentian Violet 1% ............................. First aid antespetic

📄 Do Not Use 15 words ▾

Do not use longer than 1 week, unless directed by a doctor in the eyes

📄 Ask a Doctor Before Use If 17 words ▾

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

📄 Stop Use and Ask a Doctor If 12 words ▾

Stop use and consult a doctor if conditions persist or gets worse

📄 Keep Out of Reach of Children 18 words ▾

Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center immediately.

📄 Other Information 23 words ▾

Other information product will stain clothing and skin do not use if clear seal over cap is missing or broken Warning: Cancer- wwwP65Warnings.ca.gov

📄 Package Label / Principal Display Panel 5 words ▾

Principal Display Panel EVGV PDP

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

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 Pharmadel LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pharmadel LLC 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.
← 55758-0363-60 · Pharmadel 55758-0374-02 · Pharmadel →
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.