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miconazole nitrate 20 mg/mL Solution, 29.57 mL — NDC 50268-0503-29 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

miconazole nitrate 20 mg/mL Solution, 29.57 mL — NDC 50268-503-29 (Billing 50268-0503-29)

by AvPAK · 29.57 mL in 1 BOTTLE

This is a package of 29.57 mL of miconazole nitrate 20 mg/mL Solution from AvPAK, marketed since Oct 2022 and currently FDA-listed. It is this product's only package size.

NDC 50268-0503-29
🏷️ FDA NDC (as labeled) 50268-503-29 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50268-503-29
Product NDC 50268-503
11-digit billing NDC 50268050329
NCPDP billing unit ML — per mL (volume)
RxCUI 998525
UNII VW4H1CYW1K
Application # M005
SPL Set ID eaf016f6-b631-af00-e053-2a95a90adc7b
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 2022-10-13
Route TOPICAL
Dosage form SOLUTION
Substance MICONAZOLE NITRATE

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

GCN Seq No 084120
GCN 53268
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 MICONAZOLE NITRATE 2% SOLUTION
FDB brand name Miconazole Nitrate
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 084120
  • GCN: 53268
  • HICL (First Databank): 003031
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 998525
Why two NDCs? The FDA registers this code as 50268-503-29 — 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 → 50268-0503-29. 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.

Clinical

Label name MICONAZOLE NITRATE 2% SOLUTION 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
  • It treats fungal and yeast infections. Depending on the product, that means vaginal yeast infections, athlete's foot, jock itch, ringworm, or thrush in the mouth and throat (Oravig...
  • Apply it to your upper gum in the morning after brushing, with dry hands. Hold it in place for 30 seconds. Don't crush, chew or swallow it. Use it once a day for 14 days.
  • Most are mild, like diarrhea, nausea, headache, upper belly pain or a change in taste. Vaginal products may cause mild burning or itching at first. Stop and get help for hives, tro...
  • Tell me if you take warfarin. Miconazole can boost its blood-thinning effect, so watch for bleeding or bruising. With Oravig, oral diabetes medicines, phenytoin and ergot alkaloids...
📖 Read our full Miconazole guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.
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
50268-0503-29 You're viewing this Main listing 29.57 mL in 1 BOTTLE 2022-10-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
fungoid tincture 20 mg/mL 00884-0293-01 Pedinol 1 bottle — — FDA listed —
miconazole nitrate 20 mg/mLthis 50268-0503-29 AvPAK 29.57 ml — — FDA listed —
Azolen 20 mg/mL 58980-0818-10 Stratus 1 bottle — — FDA listed —
Azolen 2 mg/g 58980-0819-60 STRATUS 1 bottle — — FDA listed —
Vite20 .3 mg/15mL 63347-0810-01 Blaine 1 bottle — — 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

🏛️
2022
On the market since
Oct 2022
📍
2026
Currently FDA-listed
4 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.

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

The official label also statesGlacial Acetic Acid, Laureth-4, Propylene glycol, Sodium Hydroxide, Sodium Metabisulfite

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.

Manufacturer & labeler

LabelerAvPAK
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code50268
First marketedOct 2022
Product typeHuman Otc Drug
Portfolio348 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.

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 34 words ▾

Uses Cures most athlete’s foot (tinea pedis) and ring worm (tinea corporis). Under professional supervision, Miconazole Nitrate 2% Solution can be used for the treatment of superficial skin infections caused by yeast (Candida albicans).

⏱️ Dosage and Administration 139 words ▾

Directions Cleanse and dry affected areas. Apply a thin application twice a day (morning and night) on skin under nails and surrounding cuticle areas or as recommended by your doctor or pharmacist. Remove Miconazole Nitrate 2% Solution from any untreated areas.

Remove from all inanimate environmental surfaces. Supervise children in the use of this product. For athlete’s foot, pay special attention to the spaces between the toes; wear well fitting, ventilated shoes and change shoes and socks at least once a day.

For athlete’s foot and ringworm use daily for 4 weeks. For fungal infections of the nail bed, if conditions persist, consult a doctor who may choose to debride or remove the nail to allow application of Miconazole Nitrate 2% Solution to the skin of the nail bed. This product is not effective on the scalp or nails.

⚠️ Warnings 90 words ▾

WARNINGS DO NOT USE ON CHILDREN UNDER TWO YEARS OF AGE EXCEPT UNDER THE ADVICE AND SUPERVISION OF A DOCTOR. FOR EXTERNAL USE ONLY. KEEP OUT OF THE REACH OF CHILDREN.

In case of accidental ingestion, seek professional assistance or contact Poison Control Center immediately. Avoid contact with eyes. If irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor or pharmacist.

Do not use if you are diabetic or have circulatory, renal, or hepatic problems, consult a doctor or pharmacist before using.

📦 How Supplied / Storage and Handling 17 words ▾

HOW SUPPLIED NDC# 50268-503-29 1 fl. oz. (29.57mL) bottle with brush applicator containing an alcohol-free clear solution.

📦 Storage and Handling ~3 min read ▾

Other Information Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. [See USP Controlled Room Temperature]. Protect from freezing.

If freezing occurs, warm to room temperature. For product questions, or to report a serious adverse event, call 1-855-361-3993. Regardless of your level of personal hygiene, your skin can be covered with microscopic organisms, including molds and yeast like fungi.

While most microorganisms are not harmful, some can invade your skin and cause an infection. FUNGUS TYPES: Mold-like fungi called dermatophytes cause athlete’s foot, jock itch, and ringworm of the skin or scalp. These fungi live on dead tissue of your hair, nails, and the outer layer of your skin.

Poor hygiene, continually moist skin, and minor skin or nail injuries increase your chances of developing a fungal infection. Athlete’s Foot and Jock Itch: Athlete’s foot and jock itch are skin conditions caused by fungi that thrive in warm, moist areas. In all cases, itching and rash are the most noticeable symptoms.

Athlete’s foot produces itching, stinging, and burning on the soles of the feet, palms and between fingers and toes. Cracking and peeling of the skin may occur as well. Jock itch consists of itching in the groin and anal areas.

Ringworm: Most common in children, ringworm causes a ringshaped pattern on the skin or scalp that grow outward as the infection spreads. The ring itself is the most actively infected area, while the skin inside the ring is less actively infected. Ringworm is very contagious and can be passed from shared hats, combs or brushes and barber tools.

Ringworm infections can also develop from contact with pets or domestic animals. To treat the infection, wash the area and dry thoroughly. Apply a thin layer of Miconazole Nitrate 2% Solution twice a day (morning and evening) over the affected area or as recommended by a doctor.

Use daily for 4 weeks. PREVENTIONS AND TREATMENT: Athlete’s Foot and Jock Itch: Good personal hygiene is essential in preventing or treating athlete’s foot and jock itch. To prevent athlete’s foot, wear well-fitting, well-ventilated shoes and change shoes and socks at least once a day.

For treatment, apply Miconazole Nitrate 2% Solution twice daily (morning and evening) or as directed by a doctor and pay special attention to the areas between toes. Apply twice a day on skin under nails and surrounding cuticle areas. Continue treatment twice a day for 4 weeks.

To prevent jock itch, keep the groin and anal areas clean and dry, avoid chaffing and launder athletic supports frequently. For treatment, use Miconazole Nitrate 2% Solution in the same manner over the affected area. Continue treatment for 2 weeks.

Fingernails and Toenails-General Information: Your nails are produced from cells in the tips of your fingers and toes and are composed of laminated layers a protein called “Keratin”. Each nail grows towards the end of your finger or toe from a nail root that extends back into a groove of skin. Just in front of your nail root is your cuticle skin, which is attached to the nail surface and helps protect the new keratin cells that slowly emerge from below.

The following lists conditions that may develop in your nails and how to take proper care of your nails. Paronychia Signs and Symptoms: (Red swollen area on the skin next to a nail): Paronychia is a superficial infection of the skin around the nail, most commonly caused by either staphylococci or yeast. Superficial pus blisters may appear.

Pressing the affected area can produce oozing pus. Paronychia may also be caused by fungal infections and is common among those with diabetes mellitus and those who may have their hands in water for long periods. Like other fungal infections, paronychia may develop slowly, but prove…

🧪 Active Ingredient 5 words ▾

Active Ingredient Miconazole Nitrate 2%

🧪 Inactive Ingredients 12 words ▾

Inactive Ingredients Glacial Acetic Acid, Laureth-4, Propylene glycol, Sodium Hydroxide, Sodium Metabisulfite

🎯 Purpose 3 words ▾

Purpose Topical Antifungal

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

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.

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 AvPAK. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AvPAK 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.
← 50268-0501-01 · AvPAK 50268-0504-15 · AvPAK →
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.