HomeNDC LookupIngredientsTolnaftate › 87885-0001-01
MiratiFul Nail Fungus Treatment Tolnaftate 1 g/100mL Solution, 15 mL — NDC 87885-0001-01 package photo

MiratiFul Nail Fungus Treatment Tolnaftate 1 g/100mL Solution, 15 mL

by Texas MiratiFul Enterprises Inc. · 15 mL in 1 BOTTLE, WITH APPLICATOR (87885-001-01)
NDC 87885-0001-01
🏷️ FDA NDC (as labeled) 87885-001-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 20, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 87885-001-01
Product NDC 87885-001
11-digit billing NDC 87885000101
RxCUI 313423
UNII 06KB629TKV
UPC 0884400525154
Application # M005
SPL Set ID 35eb20e3-86d4-4bec-b572-3d5fe86ac74d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-03
Route TOPICAL
Dosage form SOLUTION
Substance TOLNAFTATE
Why two NDCs? The FDA registers this code as 87885-001-01 — 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 → 87885-0001-01. 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 antifungals for topical use class.

Drug family (ATC) Other antifungals for topical use
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.

🏭 Manufacturer & labeler

LabelerTexas MiratiFul Enterprises Inc.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code87885
First marketedAug 2026
Product typeHuman Otc Drug
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 it is MedlinePlus · NLM

Tolnaftate stops the growth of fungi that cause skin infections, including athlete's foot, jock itch, and ringworm. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on what you're treating. For athlete's foot and ringworm, plan on using it daily for about 4 weeks. For jock itch, 2 weeks is the usual course. Some products mention you...
  • How long does it take for tolnaftate to work?
  • Tolnaftate is not effective for treating infections on the scalp or on the nails themselves — most products say so right on the label. Some liquid and patch products are designed t...
  • Stop applying the product and let your doctor know. A little initial sensitivity can happen, but worsening irritation is a sign that you should get it checked out. Don't push throu...
📖 Read our full Tolnaftate guide →
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.

🧪 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 H4N855PNZ1
    Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
  • UNII 66YXD4DKO9
    A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
  • UNII 4DKJ9B3K2T
    A natural oil derived from neem tree seeds, used in medicines as an emollient and skin-conditioning agent to help soften and protect the product's texture.
  • UNII QYO8Q067D0
    Citronella oil is a natural plant-derived oil used as a fragrance and flavoring agent in medicines. It provides taste and aroma to make medications more palatable for patients.
  • UNII 578389D6D0
    Clove oil is an essential oil derived from clove plant buds. It's used in medicines as a flavoring agent and for its mild preservative properties to help maintain product stability.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • 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.

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

The official label also statesPrunus amygdalus dulcis (Sweet almond) oil, Cymbopogan nardus (Citronella) oil, Lavandula augustifolia (Lavender) oil, Melaleuca alternifolia (Tea tree) oil, Simmondsia chinensis (Jojoba) oil, Syzyglum aromaticum (Clovebud) oil, Azadirachta indica (Neem) oil, Tocopheryl acetate (Vitamin E)

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 DailyMedingredient 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.
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
CLARUS Antifungal 1 g/100mL 44577-0002-01 Clinical 15 ml FDA listed
Hi Vetic 1 g/100mL 49873-0050-02 Sato 1 bottle FDA listed
CIDACIN Antifungal Treatment 1 g/100mL 51151-0000-01 Pedicis 1 bottle FDA listed
Athletes Foot 1 g/100mL 83837-0002-01 Imperial 75 ml FDA listed
Nail Renovar Plus 1 g/100mL 50405-0030-02 SOHM, 15 ml FDA listed
Opti-Nail 2-in-1 1 g/100mL 55505-0219-67 Kramer 5 ml FDA listed
Terramed Just Think Comfort Armor Antifungal Body Wash Citrus 1 g/100mL 83004-0036-01 Rida 500 ml FDA listed
TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid 1 g/100mL 84614-0002-01 Shenzhen 2 bottles FDA listed
Terramed Just Think Comfort Armor Antifungal Body Wash Icy Cool Menthol 1 g/100mL 83004-0037-01 Rida 500 ml FDA listed
Toe Fungus 1 g/100mL 83837-0001-01 Imperial 75 ml FDA listed
Silka Antifungal 1 g/100mL 50066-0085-01 Genomma 1 bottle FDA listed
Terramed Just Think Comfort Armor Antifungal Body Wash Lavender and chamomile 1 g/100mL 83004-0035-01 Rida 500 ml FDA listed
Fungi Nail Anti-Fungal Pen 1 g/100mL 55505-0193-51 Kramer 1 tube FDA listed
Nail Renew 1 g/100mL 62858-0101-51 Nailrenew 1 bottle FDA listed
MiratiFul Nail Fungus Treatment 1 g/100mLthis 87885-0001-01 Texas 15 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 MiratiFul Nail Fungus Treatment (this brand).

Top reported reactions

Arthralgia17
Diarrhoea16
Fatigue13
Headache13
Rash Erythematous13
Blood Potassium Increased12
Bronchopulmonary Aspergillosis11

Age at onset

Child5
Adult15
Elderly14

Reporter sex

185 reports
Male · 50%
Female · 50%

Serious outcomes

Hospitalization64
Death12
Disabling9
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 18 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
87885-0001-01 You're viewing this 15 mL in 1 BOTTLE, WITH APPLICATOR (87885-001-01) 2026-08-03 Active

🧭 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 87885-001-01, 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: 87885-0001-01, written without dashes as 87885000101. 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 87885-0001-01, the first segment (87885) is the labeler code FDA assigned to Texas MiratiFul Enterprises Inc.; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Texas MiratiFul Enterprises Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Texas MiratiFul Enterprises 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 25 words

Uses Effective treatment of athlete’s foot, jock itch, and ringworm. Not for the relief of infected fingernails and toenails or effective against bacteria or viruses.

⏱️ Dosage and Administration 99 words

Directions ▪ Clean or wash the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product.

For athelete’s foot: Pay special attention to spaces between 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 doctor.

This product is not effective on the scalp or nails.

⚠️ Warnings 102 words

Warnings ▪ For external use only. ▪ Avoid contact with the eyes. ▪ Do not use on children under 2 years of age unless directed by a doctor. ▪ Keep this and all drugs out of the reach of children. ▪ If treating athlete’s foot and ringworm: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. ▪ If treating jock itch: If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor. ▪ If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 6 words

Active Ingredient Purpose Tolnaftate 1% Antifungal

🧪 Inactive Ingredients 37 words

Inactive Ingredients Prunus amygdalus dulcis (Sweet almond) oil, Cymbopogan nardus (Citronella) oil, Lavandula augustifolia (Lavender) oil, Melaleuca alternifolia (Tea tree) oil, Simmondsia chinensis (Jojoba) oil, Syzyglum aromaticum (Clovebud) oil, Azadirachta indica (Neem) oil, Tocopheryl acetate (Vitamin E)

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