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Miconazole Nitrate 20 mg/g Cream — NDC 70677-1000-01 package photo

Miconazole Nitrate 20 mg/g Cream

by STRATEGIC SOURCING SERVICES LLC · 1 TUBE in 1 CARTON (70677-1000-1) / 30 g in 1 TUBE
NDC 70677-1000-01
🏷️ FDA NDC (as labeled) 70677-1000-1 billing pads the package 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) 70677-1000-1
Product NDC 70677-1000
11-digit billing NDC 70677100001
NCPDP billing unit GM — per gram (weight)
RxCUI 998483
UNII VW4H1CYW1K
Application # M005
SPL Set ID 966a1000-3b08-4f2c-a9f8-568f2524b717
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 2023-07-14
Route TOPICAL
Dosage form CREAM
Substance MICONAZOLE NITRATE
GPI-14 90154050103705
GCN Seq No 007366
GCN 30400
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 FT ANTIFUNGAL 2% TOPICAL CREAM
FDB brand name Antifungal Cream
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70677-1000-1 — a 5-4-1 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 package segment → 70677-1000-01. 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

LabelerSTRATEGIC SOURCING SERVICES LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code70677
First marketedJul 2023
Product typeHuman Otc Drug
Portfolio316 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 FT ANTIFUNGAL 2% TOPICAL CREAM 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 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 0324G66D0E
    Glycol stearate is a waxy compound made by combining stearic acid with ethylene glycol. It acts as an emulsifier and thickener, helping keep oil and water mixed together smoothly in liquid or semi-solid medicines.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 993L8OB0ER
    A synthetic mixture of polyethylene glycol and linoleic acid-derived compounds. This emulsifier helps blend oil and water-based ingredients together and improves how the medicine disperses and absorbs in the body.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesbenzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water

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 $0.120 $3.59 / 30 g
Medicaid paysCMS SDUD · 12 mo $0.2721 $8.16 / 30 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $0.143 $0.116
▼ Down 17% over the last 12 months.
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
Antifungal Cream 2 g/100g 21922-0095-06 Encube 1 tube $0.080 Availability likely save 33%
Antifungal Cream 2 g/100g 68001-0481-45 BluePoint 1 tube $0.083 Availability likely save 31%
Miconazole Nitrate Cream USP, 2% 2 g/100g 70000-0340-01 Cardinal 28.4 g $0.083 Availability likely save 31%
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 00536-1375-75 Rugby 1 tube $0.119 Availability likely
Miconazole Nitrate 20 mg/gthis 70677-1000-01 STRATEGIC 1 tube $0.119 Availability likely
SUNMARK MICONAZOLE NITRATE antifungal 20 mg/g 49348-0689-72 Strategic 1 tube $0.122 Availability likely +2%
Miconazole Nitrate 20 mg/g 51672-2001-01 Sun 1 tube $0.203 Availability likely +70%
Selan Antifungal 2 g/100g 00159-2500-04 Trividia 117 g FDA listed
Desenex Antifungal Foot Cream 20 mg/g 00316-0255-01 Crown 1 tube FDA listed
Baza Antifungal 20 mg/g 11701-0045-14 Coloplast 142 g FDA listed
MacerRx Web 2 g/100g 44577-0205-56 Clinical 1 tube FDA listed
Miconazole Nitrate 20 mg/g 50090-1071-00 A-S 1 tube FDA listed
Miconazole Nitrate 20 mg/g 50090-5607-00 A-S 1 tube FDA listed
Miconazole Nitrate 20 mg/g 50090-5674-00 A-S 1 tube FDA listed
Miconazole Nitrate 20 mg/g 50090-7364-00 A-S 1 tube FDA listed
CAREALL Miconazole Nitrate 20 mg/g 51824-0078-01 New 28 g FDA listed
Anti-Fungal .02 g/g 52000-0021-37 Universal 1 tube FDA listed
Medline 20 mg/mL 53329-0147-44 Medline 118 ml FDA listed
Remedy Antifungal With Olivamine 2 g/100g 53329-0162-04 Medline 113 g Discontinued
Medline 20 mg/100g 53329-0218-44 Medline 113 g FDA listed
ProCure Antifungal Cream 2 g/100g 55681-0023-04 Twin 106 g FDA listed
ProCure Antifungal 2 g/100g 55681-0047-04 Twin 106 g FDA listed
Lasolex AC 2 g/100g 59088-0239-07 PureTek 85 g FDA listed
Conazol 20 mg/g 59208-0001-30 Laboratorios 30 g FDA listed
Private Label Antifungal Barrier Cream 20 g/1000g 60232-0009-02 Swiss-American 60 g FDA listed
BOA VIDA Antifungal 2 g/100g 62654-0147-01 Central 113 g FDA listed
Micatin 20 mg/g 65197-0103-05 WellSpring 14 g FDA listed
Antifungal 2 g/100g 67777-0710-02 Dynarex 144 packets FDA listed
Miconazole 20 mg/g 68016-0291-01 Chain 1 tube FDA listed
MICONAZOLE Nitrate 2 g/100g 68071-3429-03 NuCare 1 tube FDA listed
Antifungal Body 2 mg/100mL 68599-0206-04 McKesson 118 ml FDA listed
Miconazole Nitrate 2 mg/100mg 68599-1471-04 McKesson 118 mg FDA listed
Antifungal Cream 2 g/100g 68788-8645-02 Preferred 1 tube FDA listed
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 68788-8845-03 Preferred 1 tube FDA listed
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 68788-8895-03 Preferred 1 tube FDA listed
PiYanPing Antifungal 2 g/100g 69070-0304-01 Zhejiang 1 tube FDA listed
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 69396-0014-05 Trifecta 15 g FDA listed
FifthPulse Miconazole Nitrate Cream 1oz 20 mg/g 69571-0016-01 Front 28.4 g FDA listed
FifthPulse Miconazole Nitrate Cream 4oz 2 g/100g 69571-0017-01 Front 113.4 g FDA listed
Secura Antifungal Greaseless 20 mg/g 69740-0328-00 Smith 57 g FDA listed
Secura Antifungal Extra Thick 20 mg/g 69740-0329-00 Smith 92 g FDA listed
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 69771-0041-25 GERI-GENTLE 113 g FDA listed
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 70000-0718-01 Cardinal 1 tube FDA listed
MICONAZOLE Nitrate 2% 2 g/100g 71399-0071-01 Akron 1 tube FDA listed
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 77338-0041-25 ASTONEA 113 g FDA listed
Athletes Foot 2 g/100mL 83004-0014-01 Rida 1 bottle FDA listed
Fungazol Athlete Foot 2 g/100mL 83004-0025-01 Rida 1 bottle FDA listed
Pharmlitalia Jock Itch Miconazole Nitrate 2 g/100mL 83004-0031-01 Rida 1 jar FDA listed
ElixirTripleGuard Triple Antibiotic 2 g/100g 84546-0007-01 ELIXIR 113 g FDA listed
Hermon Jock Itch Ringworm and athlete s foot cream 2 g/100g 84746-0008-01 Shandong 100 g Discontinued
Nedtol Folliculitis Treatment Creams 2 g/100g 84867-0022-01 Jiashen 120 g FDA listed
Beilloso Balanitis Relief 2 g/100mL 85248-0138-01 Jiangxi 30 ml FDA listed
Inlifay ANTIFUNGAL 2 g/100g 85248-0139-01 Jiangxi 100 g FDA listed
Charmpoo Antifungal Cream 2 g/100g 85248-0142-01 Jiangxi 100 g FDA listed
Charmpoo Antifungal Cream 2 g/100g 85248-0212-01 Jiangxi 30 g FDA listed
Charmpoo Antifungal Cream 2 g/100g 85248-0226-01 Jiangxi 2 tubes FDA listed
BODYKOO ATHLETE FOOT Cream 2 g/100g 85248-0229-01 Jiangxi 30 g FDA listed
Tagrid Jock Itch Miconazole Nitrate 2% 20 mg/g 85384-0003-01 TAGRID 100 g FDA listed
Ringworm Treatment Cream 2 g/100g 85398-0024-01 Beautivity 100 g FDA listed
Hermon Jock Itch Antifungal Treatment Cream 1.2 g/60g 85398-0032-01 Beautivity 60 g FDA listed
RoyceDerm Tinea Antifungal Cream 20 mg/g 85424-0011-01 RoyceDerm 57 g FDA listed
RoyceDerm Anti-Fungal Cream 2 g/100g 85424-0021-01 RoyceDerm 100 g FDA listed
Aosorw Antifungal Cream 2 g/100g 85498-0011-01 SpineStatus 120 g FDA listed
Kerova Miconazole Nitrate 2 g/100g 85959-0001-01 Guangzhou 100 g FDA listed
Recuren Plus Antifungal Cream 20 mg/g 87014-0001-01 REGENEREN 100 g FDA listed
Recuren Plus Jock Itch Cream 20 mg/g 87014-0004-01 REGENEREN 30 g FDA listed
Kopa Haiku Antifungal Cream 20 mg/g 87041-0001-01 Trovina 100 g FDA listed
Kopa Haiku Antifungal Cream 20 mg/g 87041-0002-01 Trovina 30 g FDA listed
Kopa Haiku Antifungal Cream 20 mg/g 87041-0004-01 Trovina 60 g FDA listed
Kopa Haiku Ringworm Treatment Cream 20 mg/g 87041-0008-01 Trovina 30 g FDA listed
Miconazole Cream 2 g/100g 87236-0013-04 Aldermed 113 g FDA listed
Doctor Jiao Antifungal Cream 2 g/100g 87537-0002-02 Jiangxi 1 tube FDA listed
Miconazole Nitrate 20 mg/g 84387-0003-01 ALLIED 28.4 g FDA listed
Fungus Master 20 mg/g 63742-0098-01 Clinical 30 g FDA listed
FifthPulse Miconazole Nitrate Antifungal 20 mg/g 87525-0004-01 WeCare 1 tube FDA listed
Critic Aid Clear AF 20 mg/g 11701-0067-14 Coloplast 142 g FDA listed
Medline 20 mg/g 53329-0256-14 Medline 57 g FDA listed
HSENJT Antifungal Cream 20 mg/g 87951-0001-01 Huizhou 100 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

🏛️
2023
On the market since
Jul 2023
📍
2026
Currently FDA-listed
3 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70677-1000-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2.7K
Units reimbursed last 4 qtrs
97.5K
Gross reimbursed last 4 qtrs
$26.5K
Avg / prescription
$9.65
Avg / unit
$0.2721
Latest quarter Q1 2026
551Rx
Medicaid pays / g
$0.2721
gross reimbursed
vs
NADAC / g
$0.1195
acquisition cost
=
Spread
+$0.1526
+128% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
63% FFS 37% MCO
Fee-for-service · 1,723 Rx Managed care · 1,026 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 5,010 units · 87.3 per 100k residents MN Wisconsin: 8,761 units · 148 per 100k residents WI Michigan: 4,068 units · 40.5 per 100k residents MI New York: 14,697 units · 75.1 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 3,180 units · 75.1 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 480 units · 15.0 per 100k residents IA Illinois: 405 units · 3.2 per 100k residents IL Indiana: 9,020 units · 131 per 100k residents IN Ohio: 3,441 units · 29.2 per 100k residents OH Pennsylvania: 3,778 units · 29.1 per 100k residents PA New Jersey: 1,627 units · 17.5 per 100k residents NJ Massachusetts: 907 units · 13.0 per 100k residents MA California: 30,272 units · 77.7 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 2,490 units · 126 per 100k residents NE Missouri: 360 units · 5.8 per 100k residents MO Kentucky: 5,989 units · 132 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 330 units · 5.3 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 2,100 units · 28.3 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 600 units · 2.0 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.0148
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Wisconsin 148 /100k
2 Kentucky 132 /100k
3 Indiana 131 /100k
4 Nebraska 126 /100k
5 Minnesota 87.3 /100k
6 California 77.7 /100k
7 Oregon 75.1 /100k
8 New York 75.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 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

Vulvovaginal Burning Sensation1,864
Vulvovaginal Pain1,001
Vulvovaginal Pruritus616
Condition Aggravated570
Vaginal Haemorrhage482
Vulvovaginal Discomfort460
Vulvovaginal Swelling317

Age at onset

Neonate8
Infant6
Child15
Adolescent12
Adult526
Elderly274

Reporter sex

8,750 reports
Male · 18%
Female · 81%
Unknown · 0%

Serious outcomes

Hospitalization1,647
Life-threatening293
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 593 464
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 NDCDescription Marketing startStatus
70677-1000-01 You're viewing this 1 TUBE in 1 CARTON (70677-1000-1) / 30 g in 1 TUBE 2023-07-14 Active

📄 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 29 words

Uses proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm for effective relief of itching, scaling, burning and discomfort that can accompany these conditions

⏱️ Dosage and Administration 87 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 the 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 not effective on the scalp or nails

⚠️ Warnings 79 words

Warnings For external use only Do not use on children less than 2 years of age unless directed by a doctor When using this product avoid contact with the eyes Stop use and ask a doctor if irritation occurs condition persists there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

📦 Storage and Handling 51 words

Other information TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE. to open: unscrew cap, use the pointed end on cap to puncture seal store at 20° to 25°C (68° to 77°F) see carton flap or tube crimp for lot number and expiration date

🧪 Active Ingredient 6 words

Active ingredient Miconazole nitrate USP 2%

🧪 Inactive Ingredients 20 words

Inactive ingredients benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water

🎯 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.