HomeNDC LookupIngredientsMiconazole Nitrate › 69740-0328-00
Secura Antifungal Greaseless MICONAZOLE NITRATE 20 mg/g Cream, 57 g — NDC 69740-0328-00 package photo

Secura Antifungal Greaseless MICONAZOLE NITRATE 20 mg/g Cream, 57 g

by Smith & Nephew Medical Ltd · 57 g in 1 TUBE (69740-328-00)
NDC 69740-0328-00
🏷️ FDA NDC (as labeled) 69740-328-00 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) 69740-328-00
Product NDC 69740-328
11-digit billing NDC 69740032800
RxCUI 998483
UNII VW4H1CYW1K
Application # M005
SPL Set ID 9be600e4-76ec-4071-a8ec-a0b23155271d
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 2003-08-01
Route TOPICAL
Dosage form CREAM
Substance MICONAZOLE NITRATE
Why two NDCs? The FDA registers this code as 69740-328-00 — 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 → 69740-0328-00. 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

LabelerSmith & Nephew Medical Ltd
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code69740
First marketedAug 2003
Product typeHuman Otc Drug
Portfolio10 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

📖 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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII I835H2IHHX
    A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII 2M01ZJ4HJB
    Diheptyl adipate is a synthetic oily compound used as a plasticizer and solvent in medicines. It helps soften and improve the flexibility of coatings or films applied to tablets and capsules.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII UYY8LE6Q5Y
    Octyl palmitate is a fatty acid ester made from palm oil. It works as an emollient and lubricant in topical products to help soften skin and reduce friction during application.
  • UNII 772Y4UFC8B
    Octyl stearate is an oily compound made from stearic acid and octanol. It works as a lubricant and emollient in medicines to help them flow smoothly during manufacturing and reduce sticking.
  • UNII 4ERD2076EF
    A synthetic liquid made by combining polyethylene glycol with castor oil. It works as a solubilizer and emulsifier to help mix water and oil-based ingredients, keeping the medicine uniform throughout the product.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 7ZBS06BH4B
    A synthetic surfactant derived from coconut or palm oil. It helps other ingredients blend evenly throughout the medicine and improves how the product spreads or dissolves, acting as an emulsifier and detergent.
  • UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • 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.

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

The official label also statesAntifungal Greaseless allantoin, cetearyl alcohol, ceteth-20, citric acid, diazolidinyl urea, dioctyl adipate, glyceryl stearate, methylparaben, octyl palmitate, octyl stearate, PEG-40 castor oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium citrate, tocopheryl acetate, water Antifungal Extra Thick benzethonium chloride, butylparaben, cellulose gum, diazolidinyl urea, methylparaben, methyl glucose dioleate, mineral oil, petrolatum, tocopheryl acetate, water, xanthan gum, zinc oxide

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
Antifungal Cream 2 g/100g 21922-0095-06 Encube 1 tube $0.080 Availability likely
Antifungal Cream 2 g/100g 68001-0481-45 BluePoint 1 tube $0.083 Availability likely
Miconazole Nitrate Cream USP, 2% 2 g/100g 70000-0340-01 Cardinal 28.4 g $0.083 Availability likely
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 00536-1375-75 Rugby 1 tube $0.119 Availability likely
Miconazole Nitrate 20 mg/g 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
Miconazole Nitrate 20 mg/g 51672-2001-01 Sun 1 tube $0.203 Availability likely
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/gthis 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

🏛️
2003
On the market since
Aug 2003
📍
2026
Currently FDA-listed
23 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
69740-0328-00 You're viewing this 57 g in 1 TUBE (69740-328-00) 2003-08-01 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 69740-328-00, 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: 69740-0328-00, written without dashes as 69740032800. 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 69740-0328-00, the first segment (69740) is the labeler code FDA assigned to Smith & Nephew Medical Ltd; the middle segment (0328) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 Smith & Nephew Medical Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Smith & Nephew Medical Ltd 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 Antifungal Extra Thick Cures most jock itch (tinea cruris), ringworm (tinea corporis) and athlete's foot (tinea pedis) Antifungal Greaseless Cures most athlete's foot, jock itch and ringworm

⏱️ Dosage and Administration 97 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 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 128 words

WARNINGS For external use only Do not use on children under 2 years old unless directed by a doctor Avoid contact with the eyes For jock itch: If irritation occurs or it there is no improvement within 2 weeks, discontinue use and consult a doctor For the treatment of athlete's foot and ringworm : If irritaion occurs or it there is no improvement within 4 weeks, discontinue use and consult a doctor Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately Updated in line with latest OTC Monograph Addition of 'Unless directed by doctor' to 'Do not use on children under 2 years old'.

Separation and expansion of 'For jock itch' and 'For athlete's foot and ringworm' warnings

🧪 Active Ingredient 5 words

ACTIVE INGREDIENTS Miconazole nitrate 2%

🧪 Inactive Ingredients 58 words

INACTIVE INGREDIENTS Antifungal Greaseless allantoin, cetearyl alcohol, ceteth-20, citric acid, diazolidinyl urea, dioctyl adipate, glyceryl stearate, methylparaben, octyl palmitate, octyl stearate, PEG-40 castor oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium citrate, tocopheryl acetate, water Antifungal Extra Thick benzethonium chloride, butylparaben, cellulose gum, diazolidinyl urea, methylparaben, methyl glucose dioleate, mineral oil, petrolatum, tocopheryl acetate, water, xanthan gum, zinc oxide

🎯 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.