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Mycozyl AL Tolnaftate .3 g/30mL Liquid, 30 mL — NDC 59088-0443-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mycozyl AL Tolnaftate .3 g/30mL Liquid, 30 mL — NDC 59088-443-03 (Billing 59088-0443-03)

by PureTek Corporation · 30 mL in 1 BOTTLE, WITH APPLICATOR

This is a package of 30 mL of Mycozyl AL Tolnaftate .3 g/30mL Liquid from PureTek Corporation, marketed since Jun 2021 and currently FDA-listed.

NDC 59088-0443-03
🏷️ FDA NDC (as labeled) 59088-443-03 billing pads the product segment with a zero
This package
Contains30 mL Pack sizes2 compare ↓
Product page 59088-0443-01 Also comes in: 10 ml 59088-443-01
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 59088-443-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
59088 labeler · 443 product · 03 package
Listing certified through
Dec 31, 2026
Billing quantity
30 mL per package
Barcode (UPC-A, from the NDC)
3 5908844303 3
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 59088-443-03
Product NDC 59088-443
11-digit billing NDC 59088044303
NCPDP billing unit ML — per mL (volume)
RxCUI 313423
UNII 06KB629TKV
Application # M005
SPL Set ID c45c8f8f-9042-a428-e053-2a95a90acda9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-06-09
Route TOPICAL
Dosage form LIQUID
Substance TOLNAFTATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90150085002005
GPI class Mycozyl AL
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 MYCOZYL AL 1% LIQUID
FDB brand name Mycozyl Al
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 007341
  • GCN: 30320
  • GPI-14 (Medi-Span): 90150085002005
  • HICL (First Databank): 003186
  • AHFS class code: 84:04.08.40
  • RxCUI (RxNorm): 313423
Why two NDCs? The FDA registers this code as 59088-443-03 — 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 → 59088-0443-03. 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.

Clinical

Label name MYCOZYL AL 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 treats fungal skin infections like athlete's foot, ringworm and, in some products, jock itch. Many products also help prevent athlete's foot. Some are made for skin around the n...
  • Wash and dry the area well, then apply a thin layer. Most products are used twice a day, morning and night. The length of use varies, often 4 weeks for athlete's foot and ringworm,...
  • The main one is skin irritation. If that happens, stop using it and talk to a doctor.
  • Call if you see no improvement within 4 weeks for athlete's foot or ringworm, or 2 weeks for jock itch. Call if irritation develops. Call right away if anyone swallows it.
📖 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.

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: 10 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
59088-0443-03 You're viewing this 30 mL in 1 BOTTLE, WITH APPLICATOR 2021-06-09 — Active
59088-0443-01 59088-443-01 Main listing 10 mL in 1 BOTTLE 2023-10-17 — Active

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

Pack size FAQ

What quantity is in this package?
This package contains 30 mL — 30 ml in 1 bottle, with applicator.
How does this package differ from NDC 59088-0443-01?
Both are Mycozyl AL Tolnaftate .3 g/30mL Liquid — the drug itself is identical. This page's package is the 30 mL one, while NDC 59088-0443-01 is the 10 ml package.
What NDC number is used to bill for this package of Mycozyl AL Tolnaftate .3 g/30mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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 — — Discontinued —
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/30mLthis 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/30mL 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 — — Discontinued —
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 — — Discontinued —
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

🏛️
2021
On the market since
Jun 2021
📍
2026
Currently FDA-listed
5 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.

🧪 Avoiding an ingredient? See Tolnaftate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

From the label’s inactive-ingredient sectionApple 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.

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerPureTek Corporation
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code59088
First marketedJun 2021
Product typeHuman Otc Drug
Portfolio178 products on file

More NDCs from PureTek Corporation labeler code 59088

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 📦 How Supplied / Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 96 words ▾

Uses for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions.

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 10 words ▾

Warnings For external use only.

Warnings For external use only

📦 How Supplied / Storage and Handling 29 words ▾

How Supplied Mycozyl AL™ Antifungal Liquid is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-443-03)

🧪 Active Ingredient 9 words ▾

Active ingredient Miconazole Nitrate 2%

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 4 words ▾

Purpose Antifungal

Purpose Antifungal

📄 Do Not Use 30 words ▾

Do not use on children under 2 years of age unless directed by a doctor

Do not use on children under 2 years of age unless directed by a doctor.

📄 When Using This Product 18 words ▾

When using this product do not get into eyes

When using this product do not get into eyes

📄 Stop Use and Ask a Doctor If 75 words ▾

Stop use and ask a doctor if for athlete's foot and ringworm - irritation occurs or there is no improvement within 4 weeks for jock itch - irritation occurs or there is no improvement within 2 weeks

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 134 words ▾

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

Directions clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) 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 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.

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

📄 Package Label / Principal Display Panel 20 words ▾

Miconatate™ Packaged in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 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 Mycozyl AL (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
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.

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 PureTek Corporation. 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 10 ml (59088-0443-01). 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?
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.
← 59088-0442-07 · PureTek 59088-0444-08 · 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.