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Miconazole

Miconazole is an azole antifungal used on the skin, in the vagina, or in the mouth to treat yeast and fungal infections such as vaginal yeast infections, athlete's foot, jock itch, ringworm, and oral thrush.

Brand names Hongo Killer UltraInzoVagistatMacerRxZeasorb +11 more
Drug class Azole Antifungal
Rx/OTC Forms 11
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 225 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 7, 2026 🚨Recall on record
Other forms & routes:
Buccal Topical Vaginal
Miconazole at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Miconazole is an azole antifungal that stops fungi from building their cell membranes. It has been a familiar drugstore standby since about 1985, is widely available as a generic, and is used for vaginal yeast infections, athlete's foot, jock itch, ringworm and, as Oravig, oral thrush in adults. Most people notice only mild burning or itching where it goes on, while Oravig can bring headache, nausea, diarrhea or an odd taste. The one thing to flag is warfarin, since even the cream and vaginal forms can boost this blood thinner and cause bleeding or bruising. Stop it and get emergency help at any sign of a serious allergic reaction.

Clinical pearls

  • Vaginal miconazole can damage condoms and diaphragms, so they may fail; skip tampons, douches and spermicides during treatment too.
  • Oravig sticks to the upper gum after you brush in the morning; do not crush, chew or swallow it.
  • Vaginal symptoms that are not better in 3 days, or that come with fever, belly pain or foul-smelling discharge, need a proper exam.
  • Keep applying skin products for the full course, which runs several weeks for athlete's foot and ringworm, even after itching stops.
How we write & review this content — our editorial policy →
How you get itPrescription and over the counter
Comes asTopical cream, ointment or gel, Vaginal cream or gel, Topical powder +8
Earliest FDA record1974
Companies listing it with the FDA127
FDA label last updatedOct 25, 2023
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Miconazole, written from its FDA label.

What Miconazole is used for

▾

Miconazole treats fungal and yeast infections, with uses that depend on the product.

  • Vaginal yeast infections: vaginal creams, inserts, kits and suppositories.
  • External itching and irritation from a vaginal yeast infection: some kits and creams.
  • Athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis): skin creams, ointments and powders.
  • Superficial skin infections caused by Candida albicans: some skin powders and the Private Label Antifungal Barrier Cream.
  • Oropharyngeal candidiasis in adults: Oravig buccal tablet only.

How Miconazole works

▾

Miconazole inhibits an enzyme (cytochrome P450 14α-demethylase) that fungi need to make ergosterol. Ergosterol is an essential part of the fungal cell membrane. Miconazole also affects fat production and builds up reactive oxygen species inside the cell.

Some Candida strains with reduced susceptibility to one azole may also be less susceptible to other azoles.

Miconazole dosage

▾

Dosing depends on the product and where it is used. Follow your prescriber and the package directions.

  • Oravig: one buccal tablet on the upper gum each morning for 14 days. It can be used with normal eating and drinking.
  • Vaginal creams: one applicatorful at bedtime for 7 nights, with optional external cream twice daily for up to 7 days.
  • Skin products: applied twice daily for about 2 to 4 weeks, depending on the infection.
  • Missed dose (Dynarex Antifungal Powder): skip it and continue as usual. Don't double up.

Dosing details from the FDA-approved label

From the Miconazole prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Oravig buccal tablet (oropharyngeal candidiasis, per label dosing schedule)
    • One 50 mg buccal tablet applied to the upper gum region (canine fossa) once daily for 14 consecutive days
    • Apply in the morning after brushing teeth; do not crush, chew or swallow; if it falls off or is swallowed within the first 6 hours, reposition or replace as directed; after 6 hours or more, do not apply a new tablet until the next scheduled dose
  • Miconazole 3 kit, adults and children 12 years of age and over (vaginal insert)
    • With a disposable applicator place the insert into the vagina at bedtime
    • Throw away applicator after use
  • Miconazole 3 kit, adults and children 12 years of age and over (external cream)
    • Apply a small amount of cream onto the itchy, irritated skin outside the vagina (vulva)
    • Use 2 times daily for up to 7 days, as needed
  • Miconazole 7 vaginal cream, adults and children 12 years of age and over (applicator)
    • Insert 1 applicatorful into the vagina at bedtime for 7 nights in a row
    • Throw applicator away after use (some brands: wash applicator after use)
  • Miconazole 7 vaginal cream, adults and children 12 years of age and over (itching and irritation on skin outside the vagina)
    • Use the same tube of cream
    • Squeeze a small amount onto fingertip and apply to the itchy, irritated skin outside the vagina
    • Use 2 times daily for up to 7 days, as needed
  • Children under 12 years of age (OTC vaginal products)
    • Ask a doctor
Read the label’s full dosing text

Directions • before using this product read the enclosed consumer information leaflet for complete directions and information • adults and children 12 years of age and over: • applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away after use. • use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed. • children under 12 years of age: ask a doctor

Read the full Dosage and Administration section on DailyMed →

Miconazole side effects

▾

Side effects are mostly mild. The label names these as most common with Oravig.

Common side effects

  • Diarrhea
  • Nausea
  • Vomiting
  • Headache
  • Upper belly pain
  • Altered taste (dysgeusia)
  • Mild vaginal burning, itching or irritation (vaginal products)

When to get medical help

  • Get emergency help for signs of a severe allergic reaction (anaphylaxis). Stop Oravig right away at the first sign of an allergy.
  • Stop vaginal products and call a doctor if you get a rash or hives, belly pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.
  • Stop vaginal products and call a doctor if symptoms don't improve in 3 days or last more than 7 days.
  • If you take warfarin and notice unusual bleeding or bruising, contact your doctor.
  • If your skin condition doesn't improve after one week, check with your doctor or pharmacist (Dynarex Antifungal Powder).
  • If a vaginal product is swallowed, get medical help or call Poison Control at 1-800-222-1222.

Miconazole warnings and precautions

▾
  • Serious allergic reactions, including anaphylaxis, have been reported. Stop Oravig at the first sign.
  • Vaginal products are for vaginal use only. Use only if a doctor has previously diagnosed a vaginal yeast infection in you.
  • Fever, chills, belly or back pain, or foul-smelling discharge may signal a more serious condition.
  • Skin products are not effective on the scalp or nails.
  • Fungal skin infections spread easily. Don't share clothes, towels or shoes.

Miconazole interactions

▾

Warfarin is the main interaction.

  • Warfarin: miconazole can increase its blood-thinning effect, causing bleeding or bruising.
  • Oral diabetes medicines, phenytoin, ergot alkaloids: they use the same liver enzymes (CYP2C9 and CYP3A4), so an interaction with Oravig can't be ruled out.
  • Vaginal products: they may damage condoms and diaphragms.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Miconazole against a supplement or herb →

Before taking Miconazole

▾
  • Don't use Oravig if you are allergic to miconazole or milk protein concentrate.
  • Tell your doctor about allergies to other azole antifungals.
  • Oravig may cause fetal harm based on animal data. Ask before using any product if pregnant or breastfeeding.
  • Oravig is not established under age 16 and isn't recommended for younger children because of choking risk.
  • Oravig studies had too few people aged 65 and over to compare responses.
  • Use Oravig with caution with liver impairment. No adjustment is needed for kidney impairment.
  • For vaginal products, ask a doctor first if you have frequent infections, diabetes, a weakened immune system or HIV exposure.

Miconazole overdose

▾

Overdose with miconazole in humans has not been reported. Very little of Oravig is absorbed. Management is symptomatic and supportive care. For a swallowed vaginal product, get medical help or call Poison Control at 1-800-222-1222.

What Miconazole does in the body

▾

Miconazole stops fungal cell membranes from forming properly and adds oxidative stress inside fungal cells. It is active against Candida albicans, C. parapsilosis and C. tropicalis.

How your body processes Miconazole

▾

Oravig dissolves slowly and stays stuck to the gum for about 15 hours on average. Saliva levels peak around 7 hours after application. Blood levels were mostly too low to measure.

Absorbed miconazole is broken down by the liver, and less than 1% is found unchanged in urine. Its half-life after systemic administration is 24 hours, and it has no active metabolites.

How to store Miconazole

▾

store at 20°-25°C (68°-77°F)

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Miconazole: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Miconazole — the kind of thing our pharmacy team would talk through with you at the counter.

What is miconazole used for?

▾
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, adults only). Choose the product made for your condition.

How do I use the Oravig tablet?

▾
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.

What side effects should I expect?

▾
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, trouble breathing or other signs of a serious allergy.

Can I take it with my other medicines?

▾
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 may also be affected.

Is it safe in pregnancy?

▾
Oravig may cause fetal harm based on animal studies. For vaginal products, ask a doctor or pharmacist before using them if you are pregnant or breastfeeding.

When should I stop and call my doctor?

▾
With vaginal products, call if symptoms don't improve in 3 days or last more than 7. Also call for fever, belly pain, rash or foul-smelling discharge. For skin products, check in if there's no improvement after about a week.

Is Miconazole available over the counter?

▾
Both. Some Miconazole products are sold over the counter and others need a prescription. According to their FDA listings, the vaginal insert form is sold both ways, at different strengths or package sizes, the topical cream, ointment or gel, vaginal cream or gel, topical powder, inhaler, topical solution and topical spray forms are sold over the counter and the buccal tablet form needs a prescription. The package says which kind you have. Your pharmacist can tell you which product is right for you.

When was Miconazole first available?

▾
The earliest FDA record we hold for Miconazole is from 1974: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Miconazole was first used.

Who makes Miconazole?

▾
127 companies currently list Miconazole products in the FDA's NDC Directory, including Insight Pharmaceuticals LLC, Meijer Distribution Inc, Strategic Sourcing Services LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Miconazole on HelloPharmacist

🌿Drug & Supplement CheckerMiconazole vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Miconazole NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Miconazole Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Miconazole forms and strengths (how it comes)

Miconazole is available in 11 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Miconazole inactive ingredients by manufacturer.

Topical cream, ointment or gel

On the skin
Brands Femmesil
How this form is used
What it may be used for
  • Medline cream is used for athlete's foot, jock itch and ringworm.
  • NAIL RENU Antifungal cream is used for athlete's foot and ringworm.
  • Miconazole 3 kit is used for vaginal yeast infections and external itching and irritation from them.
Important instructions
  • Miconazole Nitrate ointment is applied in a thin layer twice daily. Athlete's foot and ringworm are treated for 4 weeks, jock itch for 2 weeks.
  • Miconazole 3 kit: the vaginal insert goes in at bedtime, and the external cream is used twice daily for up to 7 days as needed.
Available strengths 16 strengths
0.02 mg/100 g 2 mg/100 mL 15 mg/g 0.02 g/g 20 mg/100 g 20 mg/g
Show 10 more strengths Show fewer strengths
20 mg/mL 0.1 g/g 1.2 g/60 g 1.2 g/120 g 1.5 g/100 g 1.7 g/170 g 2 g/100 g 2 g/100 mL 2 g/g 200 g/1000 g
153 FDA-listed product records ⓘ

Topical powder

On the skin
Brands Desenex
How this form is used
What it may be used for
  • Remedy Antifungal powder is used for athlete's foot, jock itch and ringworm.
  • Miconazole Nitrate powder is also used for superficial skin yeast infections caused by Candida albicans.
Important instructions
  • Dynarex Antifungal Powder is not suitable for scalp or nail infections.
  • Dynarex Antifungal Powder should be used regularly and continued for at least 10 days after symptoms go away.
  • With Dynarex Antifungal Powder, wash and dry your hands after applying it and don't share clothes, towels or shoes.
  • If you miss a dose of Dynarex Antifungal Powder, skip it and don't double up.
Available strengths 4 strengths
20 mg/g 1.42 g/71 g 2 g/85 g 2 g/100 g
60 FDA-listed product records ⓘ

Inhaler

On the skin
Available strengths 2 strengths
20 mg/g 2.6 g/130 g
16 FDA-listed product records ⓘ

Buccal tablet

Inside the cheek
Brands Oravig
How this form is used
What it may be used for
  • Oravig is used for oropharyngeal candidiasis (yeast infection of the mouth and throat) in adults.
Important instructions
  • Oravig is applied to the upper gum once daily for 14 days.
  • Apply Oravig in the morning after brushing your teeth, with dry hands.
  • Hold Oravig in place with light pressure over the upper lip for 30 seconds.
  • Do not crush, chew or swallow Oravig.
Available strengths 1 strength
50 mg
3 FDA-listed product records ⓘ

Rectal suppository

Rectal
How this form is used
What it may be used for
  • Miconazole Nitrate Vaginal Suppositories are used for the local treatment of vulvovaginal candidiasis.
Important instructions
  • Miconazole Nitrate Vaginal Suppositories are used only for candidal vaginal infection, so the diagnosis should be confirmed by a clinician.
Available strengths 2 strengths
200 mg 1200 mg
3 FDA-listed product records ⓘ

Vaginal insert

Vaginal
Available strengths 2 strengths
100 mg 200 mg
3 FDA-listed product records ⓘ

Insert or device

By mouth
Available strengths 1 strength
1200 mg
2 FDA-listed product records ⓘ

Capsule

By mouth
Available strengths 1 strength
400 mg
1 FDA-listed product record ⓘ

Topical spray

On the skin
Available strengths 1 strength
2 g/100 mL
1 FDA-listed product record ⓘ

Miconazole on the U.S. market: products, makers and brands

How Miconazole appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

127 companies list 260 Miconazole product records with the FDA, mostly as topical cream, ointment or gel, vaginal cream or gel, topical powder; the earliest marketing or approval year on record is 1974. Brand names on the directory include Hongo Killer Ultra, Inzo, Vagistat and 13 more; the rest are generics.

11
Dose forms ⓘ
127
Labelers (makers, repackagers, distributors)
40
Brand names
260
FDA-listed product records ⓘ
1974
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Kit (104) · Powder (30) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Insight Pharmaceuticals LLC3%
Meijer Distribution Inc3%
Strategic Sourcing Services LLC3%
Jiangxi Yudexi Pharmaceutical Co., LTD2%
Safeway2%
A-S Medication Solutions2%
Other makers84%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Miconazole is used (Medicaid data)

A general measure of how commonly Miconazole is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Miconazole is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

130,151
Medicaid prescriptions filled (Q1–Q4 2025)
$2.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Miconazole prescribed? Of the 1,601 medications we measure, Miconazole ranks #472 by Medicaid prescriptions — more than 71% of them.

Where Miconazole ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #472 of 1,601
#467 Dextroamphetamine 132,973 Rx #468 Epinephrine / Lidocain... 132,083 Rx #469 Tranexamic Acid 131,595 Rx #470 Olanzapine / Samidorph... 130,976 Rx #471 Bisoprolol 130,591 Rx #472 Miconazole 130,151 Rx #473 Bisacodyl Rectal 127,528 Rx #474 Fluphenazine 127,346 Rx #475 Adapalene 126,305 Rx #476 Misoprostol 125,269 Rx #477 Glucagon Injection 123,688 Rx

Utilization by Miconazole product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 20 mg/mL vaginal cream is the most-dispensed Miconazole product — about 48% of these Medicaid prescriptions.

miconazole nitrate 20 MG/ML Vaginal Cream Most dispensed

62,042 Medicaid prescriptions (Q1–Q4 2025) 48% of Miconazole prescriptions shown $708,900 gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 10 of 68 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 998540

miconazole nitrate 20 MG/ML Topical Cream

54,152 Medicaid prescriptions (Q1–Q4 2025) 42% of Miconazole prescriptions shown $728,917 gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 9 of 129 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 998483

miconazole nitrate 200 MG Vaginal Insert

5,661 Medicaid prescriptions (Q1–Q4 2025) 4% of Miconazole prescriptions shown $299,783 gross reimbursement (before rebates) ≈ $53 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 992765

miconazole nitrate 0.02 MG/MG Topical Powder

5,413 Medicaid prescriptions (Q1–Q4 2025) 4% of Miconazole prescriptions shown $60,232 gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 3 of 65 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 998461

miconazole nitrate 50 MG Buccal Tablet

363 Medicaid prescriptions (Q2–Q4 2025) <1% of Miconazole prescriptions shown $437,090 gross reimbursement (before rebates) ≈ $1,204 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 998548

miconazole nitrate 0.02 MG/MG Powder Spray

301 Medicaid prescriptions (Q1–Q4 2025) <1% of Miconazole prescriptions shown $2,078 gross reimbursement (before rebates) ≈ $6.90 per prescription (gross)

Summed across the 1 of 36 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 998428

miconazole nitrate 20 MG/ML Topical Solution

51 Medicaid prescriptions (Q1–Q3 2025) <1% of Miconazole prescriptions shown $1,390 gross reimbursement (before rebates) ≈ $27 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 998525

Other Miconazole products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

2,168 Medicaid prescriptions (Q1–Q4 2025) 2% of Miconazole prescriptions shown $29,520 gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 6 of 222 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Miconazole, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 32 of 531 listed Miconazole NDCs with Medicaid activity.

Compare Miconazole products

A representative set of FDA-listed product records for Miconazole — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 260 products — FDA National Drug Code Directory. See every product, package size and price: browse all 260 Miconazole NDCs →

Miconazole side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Miconazole — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Miconazole are vulvovaginal burning sensation, vulvovaginal pain, vulvovaginal pruritus; about 40% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

8,782
Reports mentioning it
40%
Reported as serious
12
Distinct effects shown
Most reported effects
Vulvovaginal Burning Sensation
1,864
Vulvovaginal Pain
1,001
Vulvovaginal Pruritus
616
Condition Aggravated
569
Vaginal Haemorrhage
482
Vulvovaginal Discomfort
460
Vulvovaginal Swelling
317
Drug Interaction
305
Pain
276
Nausea
237
Age groups
Adult · 530Elderly · 274Child · 15Adolescent · 12Neonate · 8Infant · 6

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Miconazole in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Miconazole FDA approval history

How Miconazole went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Miconazole was first approved by the FDA in 1974 (Brand: MONISTAT-DERM · Insight Pharms); the first generic version was approved in 1992. It remains available in U.S. pharmacies today.

1974
Brand approved
Brand: MONISTAT-DERM · Insight Pharms
1992
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Miconazole recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 2 Miconazole recalls since July 2021. One of them is still ongoing and is listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Jan 10, 2024 · MEDLINE INDUSTRIES, LP - Northfield
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 Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329… Lots: Lot #s: 08926; 08926A Exp. 8/2025; 08928 Exp. 9/2025 FDA record D-0315-2024 →
Class II Oct 4, 2023 · Terminated · MEDLINE INDUSTRIES, LP - Northfield
CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
  • Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, I… Lots: Lot 007782, Exp 08/31/2024 FDA record D-0091-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Miconazole RxCUI 6932 17 dose forms · 24 strengths
  1. Dose form (SCDF) Buccal Tablet RxCUI 969071 In current FDA listings
    Clinical drug / strength (SCD) nitrate 50 MG RxCUI 998548
  2. Dose form (SCDF) Medicated Bar Soap RxCUI 1535167 In current FDA listings
    Clinical drug / strength (SCD) nitrate 0.01 MG/MG RxCUI 2701515 nitrate 0.02 MG/MG RxCUI 1535168
  3. Dose form (SCDF) Medicated Shampoo RxCUI 446476 In current FDA listings
    Clinical drug / strength (SCD) nitrate 20 MG/ML RxCUI 1944692
  4. Dose form (SCDF) Ophthalmic Solution RxCUI 377417 No current FDA listing
    Clinical drug / strength (SCD) nitrate 10 MG/ML RxCUI 998564
  5. Dose form (SCDF) Oral Gel RxCUI 385140 In current FDA listings
    Clinical drug / strength (SCD) nitrate 0.025 MG/MG RxCUI 998563 0.02 MG/MG RxCUI 562084
  6. Dose form (SCDF) Powder Spray RxCUI 385494 No current FDA listing
    Clinical drug / strength (SCD) nitrate 0.0016 MG/MG RxCUI 998560 nitrate 0.02 MG/MG RxCUI 998428
  7. Dose form (SCDF) Topical Cream RxCUI 377764 In current FDA listings
    Clinical drug / strength (SCD) nitrate 15 MG/ML RxCUI 2712237 nitrate 20 MG/ML RxCUI 998483
  8. Dose form (SCDF) Topical Gel RxCUI 377981 In current FDA listings
    Clinical drug / strength (SCD) nitrate 0.02 MG/MG RxCUI 998437
  9. Dose form (SCDF) Topical Lotion RxCUI 377765 In current FDA listings
    Clinical drug / strength (SCD) nitrate 20 MG/ML RxCUI 998521
  10. Dose form (SCDF) Topical Ointment RxCUI 372915 In current FDA listings
    Clinical drug / strength (SCD) nitrate 0.02 MG/MG RxCUI 998442
  11. Dose form (SCDF) Topical Powder RxCUI 374556 In current FDA listings
    Clinical drug / strength (SCD) nitrate 0.02 MG/MG RxCUI 998461
  12. Dose form (SCDF) Topical Solution RxCUI 372916 In current FDA listings
    Clinical drug / strength (SCD) nitrate 20 MG/ML RxCUI 998525
  13. Dose form (SCDF) Topical Spray RxCUI 377331 In current FDA listings
    Clinical drug / strength (SCD) nitrate 20 MG/ML RxCUI 998533
  14. Dose form (SCDF) Vaginal Cream RxCUI 377766 In current FDA listings
    Clinical drug / strength (SCD) nitrate 20 MG/ML RxCUI 998540 nitrate 40 MG/ML RxCUI 998544
  15. Dose form (SCDF) Vaginal Gel RxCUI 2747147 In current FDA listings
    Clinical drug / strength (SCD) nitrate 0.02 MG/MG RxCUI 2747149
  17. Dose form (SCDF) Vaginal Ointment RxCUI 1535159 In current FDA listings
    Clinical drug / strength (SCD) nitrate 0.02 MG/MG RxCUI 1535160

Look up RxCUI 6932 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Miconazole costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Cream · Topical 2 g/100 g $0.121 per gram NDC details & price history
Cream · Vaginal 2 g/100 g $0.119 per gram NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Miconazole brand names

Miconazole is sold under 16 brand names in the FDA directory — Hongo Killer Ultra, Inzo, Vagistat, MacerRx and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Hongo Killer Ultra Inzo Vagistat MacerRx Zeasorb Lagicam Aloe Vesta Antifungal Femmesil Conazol Miconazole DermaFungal Silka Powder Desenex Lasolex Terpenicol Antifungal Monistat Critic-Aid Clear

Who makes Miconazole: manufacturers and labelers

127 companies list Miconazole products with the FDA. By number of product records, the largest are Insight Pharmaceuticals LLC, Meijer Distribution Inc, Strategic Sourcing Services LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Insight Pharmaceuticals LLC 8 Meijer Distribution Inc 8 Strategic Sourcing Services LLC 8 Jiangxi Yudexi Pharmaceutical Co., LTD 6 Safeway 6 A-S Medication Solutions 5 Bayer HealthCare LLC. 5 Beautivity LLC 5 CVS Pharmacy 5 H E B 5 Medline Industries, LP 5 Preferred Pharmaceuticals Inc. 5 Premier Brands of America Inc. 5 PureTek Corporation 5 Rida LLC 5 Target Corporation 5 Wenzhou Yuyuan Pharmaceutical Co., Ltd. 5 L. Perrigo Company 4 Topco Associates LLC 4 Trovina Co. Ltd 4 Walgreen Company 4 Amazon.com Services LLC 3 American Sales Company 3 Amerisource Bergen 3

…and 103 more on the FDA NDC directory.

Miconazole drug class (RxNorm)

Miconazole 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

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Miconazole page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 25, 2023
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Miconazole.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Miconazole after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
225
Finished products in the current FDA directory
260
Companies listing them (makers, repackagers, distributors)
127
FDA labeler codes behind them ⓘ
116
Linked representative label ⓘ
Strategic Sourcing Services LLC
Linked label effective
Oct 25, 2023
Composite sections available
9
Linked SPL Set ID
09c4f6c9-ba51-47f4-95b4-d236fa45778b
Linked SPL Document ID
09c4f6c9-ba51-47f4-95b4-d236fa45778b
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Strategic Sourcing Services LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →