HomeNDC LookupIngredientsMiconazole Nitrate › 59088-0478-07
Micotrin AP Miconazole Nitrate 2 g/85g Powder, 85 g — NDC 59088-0478-07 package photo

Micotrin AP Miconazole Nitrate 2 g/85g Powder, 85 g

by PureTek Corporation · 85 g in 1 BOTTLE (59088-478-07)
NDC 59088-0478-07
🏷️ FDA NDC (as labeled) 59088-478-07 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 →
⚠️
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) 59088-478-07
Product NDC 59088-478
11-digit billing NDC 59088047807
NCPDP billing unit GM — per gram (weight)
UNII VW4H1CYW1K
UPC 0359088478073
Application # M005
SPL Set ID cbe3d495-cdee-2343-e053-2a95a90a5b82
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 2021-10-25
Route TOPICAL
Dosage form POWDER
Substance MICONAZOLE NITRATE
GPI-14 90154050102910
GPI class Micotrin 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 MICOTRIN AP 2% POWDER
FDB brand name Micotrin Ap
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 59088-478-07 — 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 → 59088-0478-07. 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.

🏭 Manufacturer & labeler

LabelerPureTek Corporation
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code59088
First marketedOct 2021
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 MICOTRIN 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?
📖 Read our full Miconazole 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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 9S60Q72309
    A plant-derived ingredient made from safflower seed components. It acts as an emulsifier and carrier to help distribute oils and active ingredients evenly throughout the medicine.
  • UNII C5529G5JPQ
    Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII TP11QR7B8R
    A natural oil extracted from kukui nuts, used as an emollient and skin-conditioning agent in topical medicines. It helps soften the formulation and improve how the product spreads and absorbs into skin.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII 446U8J075B
    Nylon-12 is a synthetic plastic polymer used as a coating or film-forming agent in medicines. It helps create a protective barrier around tablets or capsules to control how and when the medicine is released in the body.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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

The official label also statesAleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Bisabolol, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance, Nylon-12, Silica, Sodium Benzoate, Sodium Hyaluronate, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract.

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 gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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/85g 59088-0442-07 PureTek 85 g FDA listed
Micotrin AP 2 g/85gthis 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

🏛️
2021
On the market since
Oct 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.

📊 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
59088-0478-07 You're viewing this 85 g in 1 BOTTLE (59088-478-07) 2021-10-25 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 59088-478-07, 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: 59088-0478-07, written without dashes as 59088047807. 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 59088-0478-07, the first segment (59088) is the labeler code FDA assigned to PureTek Corporation; the middle segment (0478) 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 28 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.

⏱️ Dosage and Administration 96 words

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.

⚠️ Warnings 84 words

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

🧪 Active Ingredient 5 words

Active ingredient Miconazole Nitrate 2.0%

🧪 Inactive Ingredients 35 words

Inactive ingredients Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Bisabolol, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance, Nylon-12, Silica, Sodium Benzoate, Sodium Hyaluronate, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract.

🎯 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 ↗
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.