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Vite20 UNDECYLENIC ACID 2 mg/20mL Cream, 20 mL — NDC 63347-0800-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vite20 UNDECYLENIC ACID 2 mg/20mL Cream, 20 mL — NDC 63347-800-01 (Billing 63347-0800-01)

by Blaine Labs Inc. · 20 mL in 1 TUBE

This is a package of 20 mL of Vite20 UNDECYLENIC ACID 2 mg/20mL Cream from Blaine Labs Inc., marketed since Feb 2012 and currently FDA-listed. It is this product's only package size.

NDC 63347-0800-01
🏷️ FDA NDC (as labeled) 63347-800-01 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

⚠️
Other active recalls for Undecylenic Acid (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 8, 2026 — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry (Blaine Labs Inc) · FDA recall D-0697-2026
Class II · Apr 8, 2026 — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry (Blaine Labs Inc) · FDA recall D-0694-2026
Class II · Apr 8, 2026 — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry (Blaine Labs Inc) · FDA recall D-0695-2026
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) 63347-800-01
Product NDC 63347-800
11-digit billing NDC 63347080001
UNII K3D86KJ24N
Application # M005
SPL Set ID 18f8ea1c-360e-43c0-98df-5816af4dec66
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-02-01
Route TOPICAL
Dosage form CREAM
Substance UNDECYLENIC ACID
Why two NDCs? The FDA registers this code as 63347-800-01 — 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 → 63347-0800-01. 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?

Vite20 Undecylenic Acid is a topical cream containing undecylenic acid, an antifungal ingredient commonly used in over-the-counter products. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for this class of antifungal preparations rather than undergoing individual review. Undecylenic acid is typically used in creams and similar formulations to help address fungal skin conditions.

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 gPer 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
63347-0800-01 You're viewing this Main listing 20 mL in 1 TUBE 2012-02-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vite20 2 mg/20mLthis 63347-0800-01 Blaine 20 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
Feb 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.

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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII G07GZ97H65
    Clotrimazole is an antifungal medication. In this product, it serves as the active therapeutic ingredient rather than an inactive excipient, working to treat fungal infections.
  • UNII 4828G836N6
    A plant-derived oil mixture from coconut that acts as an emollient and solvent. It helps dissolve or carry active ingredients and improves how the medicine spreads or absorbs in topical formulations.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII X70SE62ZAR
    Hydroxyethyl cellulose is a plant-derived thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a thickener for gels or liquids, and sometimes as a coating agent.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • UNII 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.
  • 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.

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

The official label also statesOTROS INGREDIENTES: Savila, Alcohol Cetilico, Clotrimazole, Caprilate de Coco, Acido Etilendiamino Tetraacetico, Estearato de Glicerilo, Celulosa Hidroxilada, Aceite de Lavanda. Metilparabeno, Polietileno de Glicol de Estearato 100, Polisorbato 60, Propilparabeno, Acido Estearico, Melaleuca, Trietanolamina, Urea, Agua. INACTIVE INGREDIENTS: Aloe Vera, Cetyl Alcohol, Clotrimazole, Coco-Caprylate/Caprate, Disodium EDTA, Glyceryl Stearic, Hydroxyethylcellulose, lavender Oil, Methylparaben, PEG-100 Stearate, Polysorbate 60, Propylparaben, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, 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

LabelerBlaine Labs Inc.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code63347
First marketedFeb 2012
Product typeHuman Otc Drug
Portfolio14 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.

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 59 words ▾

Usos USES USOS: Cura el pie de (tinea pedis), comezon en la ingle (tinea cruris) y tina (tinea corporis). Par alivio effectivo de la comezon, agrietamiento, ardor y molestias asociadas con estas enfermedades. USES:Cures athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm(tinea corpois). For effective relief of itching, cracking, burning and discomfort that can accompany these conditions.

⏱️ Dosage and Administration ~1 min read ▾

Modo De Empleo Directions MODO DE EMPLEO: Lave con aqua y jabon ;as areas afectadas y sequelas adecuadamente. Aplique una capa ligera dos veces al dia (manana y noche), o como lo haya indicado su medico. Los ninos menores de 12 anos que usen este producto deberan hacerlo bajo estricta supervision de un adulto.

En los casos de pie de atleta, debe poner atencion entre los dedos de los pies. Es recomendable que use zapatos a la medida y bien ventilados, y cambiarse de calcentines y zapatos cuando menos una vez al dia. Para el pie de atleta y la tina, use diario por cuatro semanas; papa comezon en la ingle, does semanas son suficentes.

Si no obtiene resultados en el tiemp indicado, es mejor consultar con su medico. DIRECTIONS: wash the affected area with soap and water and dry thoroughly. Apply sparingly over affected area twice daily (morning and night), or as directed by a physician.

For athlete's foot, pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer, consult a physician.

This product is not effective on scalp or nails. Supervise children in the use of this product.

⚠️ Warnings 175 words ▾

Precauciones Warnings PRECAUCIONES: No debe aplicarse en menores de 2 anos, excepto cuando su medico lo recomiende. Para uso externo unicamente. Evite el contacto con los olos.

Si observa alguna irritacion, o si no hay mejoria despues de cuatro semanas (en el pie de atleta o en la tina), o dos semanas (en la comezon el la ingle), suspenda su uso y consulte a su medico. Mantenga este y todos los medicamentos fuera del alcance de los ninos. En caso de ingestion accidental, comuniquese con el centro de salud mas cercano y pida ayuda profesional inmediatamente.

WARNINGS: Do not use on children under 2 years of age unless directed by a physician. For external use only. Avoid contact with eyes.

If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a physician. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

🧪 Active Ingredient 15 words ▾

Ingrediente Activo Active Ingredients INGREDIENTE ACTIVO: Acido Undecilenico 10 % Active Ingredient: Undecylenic Acid 10%

🧪 Inactive Ingredients 69 words ▾

Otros Ingredientes Inactive Ingredients OTROS INGREDIENTES: Savila, Alcohol Cetilico, Clotrimazole, Caprilate de Coco, Acido Etilendiamino Tetraacetico, Estearato de Glicerilo, Celulosa Hidroxilada, Aceite de Lavanda. Metilparabeno, Polietileno de Glicol de Estearato 100, Polisorbato 60, Propilparabeno, Acido Estearico, Melaleuca, Trietanolamina, Urea, Agua. INACTIVE INGREDIENTS: Aloe Vera, Cetyl Alcohol, Clotrimazole, Coco-Caprylate/Caprate, Disodium EDTA, Glyceryl Stearic, Hydroxyethylcellulose, lavender Oil, Methylparaben, PEG-100 Stearate, Polysorbate 60, Propylparaben, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, Water.

🎯 Purpose 5 words ▾

Purpose CREMA ANTIHONGOS Antifungal Cream

📄 Keep Out of Reach of Children 62 words ▾

Precauciones Keep Out Of Reach Of Children Mantenga este y todos los medicamentos fuera del alcance de los ninos. En caso de ingestion accidental, comuniquese con el centro de salud mas cercano y pida ayuda profesional inmediatamente. Keep this and all drugs out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

📄 Package Label / Principal Display Panel 31 words ▾

Package Label VITE20 CREMA ANIHONGOS Cont. Neto 20 ml para manos y pies saludables Blaine labs, Inc. Santa Fe Springs, CA 90670, U.S.A. (800) 307-8818 PNE-V20AR Rev. 20120229 Blaine Vite20 Label

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 UNDECYLENIC ACID — the ingredient across all brands.

Top reported reactions

Diarrhoea9
Graft Versus Host Disease8
Fungal Infection7
Nausea7
Neutropenia7
Pyrexia7
Sepsis7

Age at onset

Child1
Adult4
Elderly3

Reporter sex

140 reports
Male · 44%
Female · 55%
Unknown · 1%

Serious outcomes

Hospitalization45
Death30
Life-threatening6
Disabling4
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.

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 Blaine Labs Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Blaine Labs 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.
← 63347-0720-01 · Blaine 63347-0810-01 · Blaine →
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.