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Micomitin Antifungal Tolnaftate .3 g/30mL Liquid, 30 mL — NDC 59088-0640-03 package photo

Micomitin Antifungal Tolnaftate .3 g/30mL Liquid, 30 mL

by PureTek Corporation · 30 mL in 1 BOTTLE (59088-640-03)
NDC 59088-0640-03
🏷️ FDA NDC (as labeled) 59088-640-03 billing pads the product segment with a zero
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) 59088-640-03
Product NDC 59088-640
11-digit billing NDC 59088064003
NCPDP billing unit ML — per mL (volume)
RxCUI 313423
UNII 06KB629TKV
Application # M005
SPL Set ID de9842ba-0254-8ae1-e053-2995a90a0664
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-30
Route TOPICAL
Dosage form LIQUID
Substance TOLNAFTATE
GPI-14 90150085002005
GCN Seq No 007341
GCN 30320
HICL code 003186
Ingredient (HICL) Tolnaftate
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 Q5F
Therapeutic class — specific (HIC3) Topical Antifungals
AHFS code 84:04.08.40
AHFS class Thiocarbamates(Skin And Mucous Membrane)
FDB label name MICOMITIN ANTIFUNGAL 1% LIQUID
FDB brand name Micomitin
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 59088-640-03 — 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 → 59088-0640-03. 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

LabelerPureTek Corporation
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code59088
First marketedAug 2023
Product typeHuman Otc Drug
Portfolio178 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

Label name MICOMITIN ANTIFUNGAL 1% LIQUID Ingredient Tolnaftate
📖 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 WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
  • UNII 0UE22Q87VC
    Apple cider vinegar is a sour liquid made from fermented apples. It's used in medicines as a flavoring agent and to help adjust the acidity level of the product.
  • UNII 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII YOW8V9698H
    Dimethyl sulfoxide is a clear liquid solvent derived from wood pulp. In medicines, it helps dissolve or carry active ingredients and improve how the body absorbs the drug.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 6HQ855798J
    Laureth-4 is a synthetic detergent made from lauryl alcohol and ethylene oxide. It acts as an emulsifier and solubilizer, helping blend oil and water-based ingredients and improve how the body absorbs the active drug.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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.

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

The official label also statesApple Cider Vinegar, Argania Spinosa (Argan) Kernel Oil, Benzyl Alcohol, DMSO (Dimethyl Sulfoxide), Eucalyptus Globulus (Eucalyptus) Leaf Oil, Glycerin, Laureth-4, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-8, DL-alpha-tocopheryl acetate.

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 $45.52 $1,365.47 / 30 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
Maximum Strength Antifungal Liquid 10 mg/mL 00363-2026-01 Walgreens 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 00363-4471-01 Walgreens 1 bottle — — FDA listed —
Antifungal Liquid Maximum Strength 10 mg/mL 00363-7998-01 Walgreens 1 bottle — — FDA listed —
Antifungal Solution Maximum Strength 10 mg/mL 11822-9600-01 Rite 1 bottle — — FDA listed —
Meijer Maximum Strength Athletes Foot Antifungal 10 mg/g 23667-0811-01 Formulated 150 g — — Discontinued —
Signature Care Athletes Foot Antifungal 10 mg/g 23667-0813-01 Formulated 150 g — — Discontinued —
Up and Up Soothing Antifungal 10 mg/g 23667-0816-01 Formulated 150 g — — Discontinued —
ProClearz Maximum Strength Fungal Shield Brush-on Antifungal 10 mg/mL 29784-0181-02 Rooftop 1 bottle — — FDA listed —
Proclearz Professional Fungal Shield 10 mg/mL 29784-0184-01 Rooftop 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 36800-0399-01 TopCo 1 bottle — — FDA listed —
CLARUS Antifungal 1 g/100mL 44577-0002-01 Clinical 15 ml — — FDA listed —
CLARUS AC Antifungal Solution 10 mg/g 44577-0128-00 Clinical 15 g — — FDA listed —
Formula 3 10 mg/mL 49406-0003-15 The 1 bottle — — FDA listed —
Formula 7 - The Solution 1 g/100g 49406-0007-15 The 15 g — — FDA listed —
Hi Vetic 1 g/100mL 49873-0050-02 Sato 1 bottle — — FDA listed —
Silka Antifungal 1 g/100mL 50066-0085-01 Genomma 1 bottle — — FDA listed —
Nail Renovar Plus 1 g/100mL 50405-0030-02 SOHM, 15 ml — — FDA listed —
CIDACIN Antifungal Treatment 1 g/100mL 51151-0000-01 Pedicis 1 bottle — — FDA listed —
Maximum Strength Antifungal Liquid .3 g/30mL 51316-0898-00 CVS 30 ml — — FDA listed —
Toe Area Treatment 10 mg/mL 51316-0981-01 CVS 1 bottle — — FDA listed —
Fungicure Anti-Fungal Liquid 8.65 mg/mL 52389-0298-30 Kobayashi 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 55319-0538-01 Family 1 bottle — — FDA listed —
Fungi Nail Toe and Foot 10 mg/mL 55505-0177-26 Kramer 1 bottle — — FDA listed —
Fungi Nail Anti-Fungal Pen 1 g/100mL 55505-0193-51 Kramer 1 tube — — FDA listed —
Opti-Nail 2-in-1 1 g/100mL 55505-0219-67 Kramer 5 ml — — FDA listed —
Antifungal Liquid 10 mg/mL 56104-0902-01 Premier 1 bottle — — FDA listed —
Mycozyl AL .3 g/30mL 59088-0443-03 PureTek 30 ml — — FDA listed —
Micotrin AL .3 g/30mL 59088-0477-03 PureTek 30 ml — — FDA listed —
Micomitin Antifungal .3 g/30mLthis 59088-0640-03 PureTek 30 ml — — FDA listed —
Nail Renew 1 g/100mL 62858-0101-51 Nailrenew 1 bottle — — FDA listed —
Maximum Strength Antifungal Liquid 10 mg/mL 67091-0753-30 WinCo 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 70000-0680-01 LEADER/Cardinal 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 70000-0745-01 LEADER/ 1 bottle — — FDA listed —
Liquid Antifungal Treatment 10 mg/mL 72446-0012-01 Hudson 1 bottle — — FDA listed —
Maximum Strength Antifungal Liquid 10 mg/mL 72446-0013-01 Hudson 1 bottle — — FDA listed —
Novonail Solution 1 g/100mL 72839-0507-01 Derma 13.3 ml — — FDA listed —
Dermatool Fungal Nail Treatment 1 g/100mL 72839-0510-01 Derma 1 bottle — — FDA listed —
Tritolnacide S .01 g/mL 73352-0560-01 Trifluent 15 ml — — FDA listed —
Maximum Strength Antifungal Liquid 10 mg/mL 79481-0660-01 Meijer 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 79903-0256-30 Wal-Mart 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 79903-0394-01 Wal-Mart 1 bottle — — FDA listed —
Maximum Strength Antifungal Liquid 10 mg/mL 81522-0077-01 FSA 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 82442-0956-01 Target 1 bottle — — FDA listed —
Antifungal Liquid 10 mg/mL 82442-0998-01 Target 1 bottle — — FDA listed —
Maximum Strength Antifungal Liquid 10 mg/mL 83324-0301-01 Chain 1 bottle — — FDA listed —
Toe Fungus 1 g/100mL 83837-0001-01 Imperial 75 ml — — FDA listed —
Athletes Foot 1 g/100mL 83837-0002-01 Imperial 75 ml — — FDA listed —
Nailtific Nighttime Antifungal Renewal Pen Refill .06 g/6mL 84167-0023-31 Guangzhou 1 bottle — — FDA listed —
APUREE Nailtific Extra-Max Strength Nighttime Antifungal 1 g 84167-0479-02 Guangzhou 1 vial — — FDA listed —
Nail Lab Fungomer Nailelixir 1 g/100mL 84222-0002-01 Foshan 50 ml — — Discontinued —
TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid 1 g/100mL 84614-0002-01 Shenzhen 2 bottles — — FDA listed —
Dermatool Fungal Nail Treatment 1 g/100mL 84728-0510-01 Papalo 1 bottle — — FDA listed —
Nekvnro FUNGAL NAIL TREATMENT Kit 1 g/100mL 84844-0019-01 Guoyu 2 bottles — — Discontinued —
Ukova Foot Odor Probiotic 1 g/100mL 84867-0011-01 Jiashen 30 ml — — FDA listed —
UKVOA Toenail Fungus Treatment 1 g/100mL 84867-0012-01 Jiashen 30 ml — — FDA listed —
Alveora NAIL FUNGUS TREATMENT 1 g/100mL 85248-0033-01 Jiangxi 30 ml — — FDA listed —
Dermfree Fungi Nail 1 g/100mL 85248-0037-01 Jiangxi 15 ml — — FDA listed —
Cndanting Multi-Purpose Nail Repair 1 g/100mL 85248-0040-01 Jiangxi 30 ml — — FDA listed —
BeamBalm FUNGL NAIL 1 g/100mL 85248-0047-01 Jiangxi 4 ml — — FDA listed —
BeamBalm ANTIFUNGAL NAIL 1 g/100mL 85248-0048-01 Jiangxi 11 ml — — Discontinued —
Skapemed Skin Repair 1 g/100mL 85248-0054-01 Jiangxi 50 ml — — FDA listed —
Healmusz Fungi Nail 1 g/100mL 85248-0057-01 Jiangxi 15 ml — — FDA listed —
HEALMUSZ Multi-PurposeTreatment 1 g/100mL 85248-0058-01 Jiangxi 30 ml — — FDA listed —
Reinreude Multi-Purpose Treatment 1 g/100mL 85248-0072-01 Jiangxi 30 ml — — FDA listed —
Natuheal Multi -Purpose Treatment 1 g/100mL 85248-0081-01 Jiangxi 30 ml — — FDA listed —
Ourui One Fungal Nail Treatment 1 g/100mL 85248-0084-01 Jiangxi 2 bottles — — FDA listed —
PUVIDA Helps WITH NAGELPILZ 1 g/100mL 85248-0089-01 Jiangxi 2.5 ml — — FDA listed —
FIobow FUNGAL NAIL TREATMENT 1 g/100mL 85248-0095-01 Jiangxi 30 ml — — FDA listed —
Serynth Fungi Nail 1 g/100mL 85248-0108-01 Jiangxi 15 ml — — FDA listed —
Serynth Helps With Fungal Nail 1 g/100mL 85248-0109-01 Jiangxi 2.5 ml — — FDA listed —
Dermfree Helps With Nagelpilz 1 g/100mL 85248-0115-01 Jiangxi 4 ml — — FDA listed —
Folupia Fungal Nail Renewal 1 g/100mL 85248-0148-01 Jiangxi 30 ml — — FDA listed —
Tolfyra .3 g/30mL 85477-0331-01 Oncora 30 ml — — FDA listed —
Nail Fungus Treatment 1 g/100mL 85834-0001-01 Shenzhen 30 ml — — Discontinued —
Cureforte Anti Fungal Foot Care 10 mg/mL 85884-0252-02 STEEL 1 bottle — — FDA listed —
zourunan MULTI-PURPOS TREATMENT 1 g/100mL 87083-0001-01 Guchutang 30 ml — — FDA listed —
Dr. Luke FUNGAL NAIL RENEWAL 1 g/100mL 87147-0005-01 DANOUS 30 ml — — Discontinued —
nail fungus treatment 1 mg/100mg 87770-0003-01 Guangzhou 30 mg — — 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
Aug 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 59088-0640-03, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q2 2025 · 2 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
113
Units reimbursed last 4 qtrs
3.7K
Gross reimbursed last 4 qtrs
$169.3K
Avg / prescription
$1,498.39
Avg / unit
$45.5156
Latest quarter Q2 2025
94Rx
Fee-for-service vs managed care ⓘ
25% FFS 75% MCO
Fee-for-service · 28 Rx Managed care · 85 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 3,720 units · 31.6 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
31.631.6
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Ohio 31.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 Micomitin Antifungal (this brand).

Top reported reactions

Nausea820
Macular Degeneration812
Pain783
Headache747
Dyspnoea716
Fatigue653
Diarrhoea605

Age at onset

Neonate46
Infant16
Child38
Adolescent23
Adult1,092
Elderly905

Reporter sex

11,658 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization4,012
Life-threatening678
Disabling402
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 1,045 391
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
59088-0640-03 You're viewing this 30 mL in 1 BOTTLE (59088-640-03) 2023-08-30 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) ✓ Available
“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 59088-640-03, 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: 59088-0640-03, written without dashes as 59088064003. 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 59088-0640-03, the first segment (59088) is the labeler code FDA assigned to PureTek Corporation; the middle segment (0640) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 PureTek Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PureTek Corporation 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 📦 How Supplied / Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 68 words ▾

Uses for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions. for the prevention of most Athlete’s foot with daily use. eliminates fungus on fingers, toes, and around the nails. eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.

⏱️ Dosage and Administration 101 words ▾

Directions clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) paying special attention to the edges of the nail, cuticles, and skin around the nails or as directed by a doctor supervise children in the use of this product 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 if condition persists longer, consult a doctor.

Use under the direction of a medical practitioner

⚠️ Warnings 86 words ▾

Warnings For external use only Do not use on children under 2 years of age unless directed by a doctor. When using this product do not get into eyes Stop use and ask a doctor for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks for prevention of athlete’s foot - if irritation occurs, discontinue use and consult a doctor Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 How Supplied / Storage and Handling 28 words ▾

How Supplied Micomitin™ Antifungal Liquid is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-640-03)

🧪 Active Ingredient 4 words ▾

Active ingredient Tolnaftate 1%

🧪 Inactive Ingredients 35 words ▾

Inactive ingredients Apple Cider Vinegar, Argania Spinosa (Argan) Kernel Oil, Benzyl Alcohol, DMSO (Dimethyl Sulfoxide), Eucalyptus Globulus (Eucalyptus) Leaf Oil, Glycerin, Laureth-4, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-8, DL-alpha-tocopheryl acetate.

🎯 Purpose 2 words ▾

Purpose Antifungal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 59088-0630-00 · PureTek 59088-0642-07 · PureTek →
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.