Mycozyl AP Miconazole Nitrate 2 g/85g Powder, 85 g
by PureTek Corporation · 85 g in 1 BOTTLE (59088-442-07)
NDC 59088-0442-07
🏷️ FDA NDC (as labeled)
59088-442-07
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Miconazole Nitrate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 10, 2024 — Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0315-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
59088-442-07
Product NDC
59088-442
11-digit billing NDC
59088044207
NCPDP billing unit
GM — per gram (weight)
RxCUI
998461
UNII
VW4H1CYW1K
UPC
0359088442074
Application #
M005
SPL Set ID
c45c8f8f-9042-a428-e053-2a95a90acda9
Established class (EPC)
Azole Antifungal
Chemical class
Azoles
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2020-12-08
Route
TOPICAL
Dosage form
POWDER
Substance
MICONAZOLE NITRATE
GPI-14
90154050102910
GPI class
Mycozyl AP
GCN Seq No
007367
GCN
30410
HICL code
003031
Ingredient (HICL)
Miconazole Nitrate
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
84:04.08.08
AHFS class
Azoles (Skin And Mucous Membrane)
FDB label name
MYCOZYL AP 2% POWDER
FDB brand name
Mycozyl Ap
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 59088-442-07 — 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 → 59088-0442-07. 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 Azole Antifungal class.
Pharmacologic class
Azole Antifungal
Drug family (ATC)
Antiinfectives and antiseptics for local oral treatment, Imidazole derivatives, Imidazole and triazole derivatives
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 marketedDec 2020
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 MYCOZYL AP 2% POWDER Ingredient Miconazole Nitrate
📖 What it is MedlinePlus · NLM
Topical miconazole is used to treat tinea corporis(ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection. Not all products should be used to treat all of these conditions. Please read the label for each product to select the one to treat your conditi...
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- For a 7-night vaginal cream, you insert one full applicator into your vagina at bedtime for 7 nights in a row. If you have itching or irritation on the outside, squeeze a small amo...
- I bought a miconazole cream for a vaginal yeast infection — how do I use it correctly?
- Yes — topical miconazole creams and powders are specifically made for those conditions. For athlete's foot and ringworm, you'd apply it to clean, dry skin twice a day for 4 weeks....
- Can I use miconazole cream on my skin for athlete's foot or jock itch?
Patient education
Supplement & herbal interactions
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.
💬 Questions about Miconazole Nitrate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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.
💲 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 system | Per g | Per 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Miconazorb AF 20 mg/g 46122-0789-29 | AmerisourceBergen | 71 g | $0.058 | — | Availability likely | — |
| Miconazole Nitrate 1.42 g/71g 70000-0323-01 | LEADER/ | 71 g | $0.058 | — | Availability likely | — |
| Antifungal Powder 20 mg/g 70000-0679-01 | LEADER/ | 71 g | $0.058 | — | Availability likely | — |
| Desenex 20 mg/g 00316-0225-15 | Crown | 43 g | — | — | Discontinued | — |
| Zeasorb Athletes Foot 20 mg/g 00316-8000-01 | Crown | 71 g | — | — | FDA listed | — |
| Zeasorb Jock Itch 20 mg/g 00316-8001-02 | Crown | 71 g | — | — | FDA listed | — |
| Foot Powder 20 mg/g 00363-7999-01 | Walgreens | 71 g | — | — | FDA listed | — |
| Jock Itch Powder 20 mg/g 00363-9223-01 | Walgreens | 71 g | — | — | FDA listed | — |
| Miconazole Nitrate Antifungal Powder 2 g/100g 10135-0720-85 | Marlex | 85 g | — | — | FDA listed | — |
| Lotrimin AF Jock Itch 20 mg/g 11523-0150-01 | Bayer | 177 g | — | — | FDA listed | — |
| Lotrimin Antifungal 20 mg/g 11523-0919-01 | Bayer | 90 g | — | — | FDA listed | — |
| Micro-Guard (AF) 20 mg/g 11701-0038-16 | Coloplast | 85 g | — | — | FDA listed | — |
| Anti-Fungal Powder 20 mg/g 30142-0947-71 | The | 71 g | — | — | FDA listed | — |
| Miconazole Nitrate 1.42 g/71g 36800-0385-25 | Topco | 71 g | — | — | FDA listed | — |
| Anti-Fungal Powder 20 mg/g 36800-0613-01 | TopCo | 71 g | — | — | FDA listed | — |
| Miconazole Nitrate 2 g/100g 42291-0938-85 | AvKARE | 85 g | — | — | FDA listed | — |
| Anti-Fungal Powder 20 mg/g 51316-0980-01 | CVS | 71 g | — | — | FDA listed | — |
| Remedy Antifungal 2 g/100g 53329-0169-79 | Medline | 85 g | — | — | FDA listed | — |
| Miconazole Nitrate 20 mg/g 53943-0976-01 | Discount | 71 g | — | — | FDA listed | — |
| ProCure Antifungal 2 g/100g 55681-0043-03 | Twin | 85 g | — | — | FDA listed | — |
| Anti- Fungal Miconazole Nitrate 1.42 g/71g 56104-0253-01 | Premier | 71 g | — | — | FDA listed | — |
| Anti-fungal Powder Miconazole Nitrate 20 mg/g 56104-0500-00 | Premier | 71 g | — | — | FDA listed | — |
| Medicated Athletes Foot Powder 20 mg/g 56104-0906-01 | Premier | 99 g | — | — | FDA listed | — |
| Mycozyl AP 2 g/85gthis 59088-0442-07 | PureTek | 85 g | — | — | FDA listed | — |
| Micotrin AP 2 g/85g 59088-0478-07 | PureTek | 85 g | — | — | FDA listed | — |
| 1236-CS Antifungal Powder (Talc Free) 20 mg/g 67777-0313-04 | Dynarex | 24 bottles | — | — | FDA listed | — |
| THERA Antifungal Body 20 mg/g 68599-0207-03 | McKesson | 85 g | — | — | FDA listed | — |
| GeriGentle Miconazole nitrate 2 g/100g 69771-0165-03 | GERI-GENTLE | 85 g | — | — | FDA listed | — |
| Miconazole Nitrate 1.42 g/71g 69842-0490-25 | CVS | 71 g | — | — | FDA listed | — |
| Miconazole Nitrate 1.42 g/71g 72446-0007-71 | Hudson | 71 g | — | — | FDA listed | — |
| Miconazole Nitrate 20 mg/g 72446-0014-01 | Hudson | 71 g | — | — | FDA listed | — |
| DCH Labs Antifungal Jock 2 g/100g 72839-0096-02 | Derma | 71 g | — | — | FDA listed | — |
| Warrior Antifungal Foot 2 g/100g 72839-0961-02 | Derma | 71 g | — | — | FDA listed | — |
| Anti-fungal Powder Miconazole Nitrate 20 mg/g 79481-0621-01 | Meijer | 71 g | — | — | FDA listed | — |
| Antifungal 20 mg/g 80513-0771-03 | Advanced | 85 g | — | — | FDA listed | — |
| Evercare Antifungal Treatment Super Absorbent Powder 20 mg/g 83099-0000-00 | PANEFFORT, | 85 g | — | — | FDA listed | — |
| Dermachange Jock 2 g/100g 83520-0961-02 | Private | 71 g | — | — | FDA listed | — |
| Happy Nuts Jock Itch Powder 2 g/100g 87151-0111-01 | Suit | 71 g | — | — | FDA listed | — |
| Antifungal Powder 2 g/100g 87236-0012-03 | Aldermed | 85 g | — | — | 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
🏛️
2020
On the market since
Dec 2020
📍
2026
Currently FDA-listed
6 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.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Miconazole 3 (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Miconazole 3. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$35.6K
Claims incl. refills
725
Beneficiaries
649
Spend / beneficiary
$54.91
Spend / claim
$49.15
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 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 Miconazole Nitrate — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 59088-0442-07 You're viewing this | 85 g in 1 BOTTLE (59088-442-07) | 2020-12-08 | 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 59088-442-07, 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: 59088-0442-07, written without dashes as 59088044207. 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 59088-0442-07, the first segment (59088) is the labeler code FDA assigned to PureTek Corporation; the middle segment (0442) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) 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 ▾
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 ▾
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 ▾
Warnings For external use only.
Warnings For external use only
📦 How Supplied / Storage and Handling ▾
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 ▾
Active ingredient Miconazole Nitrate 2%
Active ingredient Tolnaftate 1%
🧪 Inactive Ingredients ▾
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 ▾
Purpose Antifungal
Purpose Antifungal
No label section mentions that — try another word, or open the full label on DailyMed below.
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.