Home › NDC Lookup › Ingredients › Miconazole Nitrate 2% › 85424-0031-01
RoyceDerm Athletes foot antifungal .cream. Miconazole nitrate 2% 2 g/100g Cream, 57 g — NDC 85424-0031-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

RoyceDerm Athletes foot antifungal .cream. Miconazole nitrate 2% 2 g/100g Cream, 57 g — NDC 85424-031-01 (Billing 85424-0031-01)

by RoyceDerm LLC · 57 g in 1 CARTON

This is a package of 57 g of RoyceDerm Athletes foot antifungal .cream. Miconazole nitrate 2% 2 g/100g Cream from RoyceDerm LLC, marketed since Sep 2026 and currently FDA-listed. It is this product's only package size.

NDC 85424-0031-01
🏷️ FDA NDC (as labeled) 85424-031-01 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 Sep 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

NDC database record

One package, one record: these facts belong to NDC 85424-031-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85424 labeler · 031 product · 01 package
Package marketed since
Sep 9, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8542403101 5
FDA record last changed
Sep 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85424-031-01
Product NDC 85424-031
11-digit billing NDC 85424003101
RxCUI 998483
UNII VW4H1CYW1K
Application # M005
SPL Set ID 58d23aa0-497e-4ece-e063-6294a90aef66
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 2026-09-09
Route TOPICAL
Dosage form CREAM
Substance MICONAZOLE NITRATE
Quick answers
  • RxCUI (RxNorm): 998483
Why two NDCs? The FDA registers this code as 85424-031-01 — 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 → 85424-0031-01. 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.

Clinical

📗 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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85424-0031-01 You're viewing this Main listing 57 g in 1 CARTON 2026-09-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Aosorw Antifungal Cream 2 g/100g 85498-0011-01 SpineStatus 120 g — — FDA listed —
RoyceDerm Anti-Fungal Cream 2 g/100g 85424-0021-01 RoyceDerm 100 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 —
Ringworm Treatment Cream 2 g/100g 85398-0024-01 Beautivity 100 g — — FDA listed —
RoyceDerm Athletes foot antifungal .cream. 2 g/100gthis 85424-0031-01 RoyceDerm 57 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

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 04W97Z676Y
    A plant-derived natural substance from Bassia scoparia fruit used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping in the tablet or capsule.
  • UNII JK0MS9P8YL
    Cnidium monnieri fruit oil is a plant-derived oil extracted from the fruit of Cnidium monnieri (Chinese motherwort). In medicines, it serves as a fragrance component, skin conditioning agent, or delivery vehicle to improve product stability and absorption.
  • UNII 6153LEN214
    A plant extract from the root of Dictamnus dasycarpus, used in some formulations as a natural flavoring agent, fragrance component, or traditional botanical ingredient to enhance taste or aroma.
  • UNII PES3YXA3LR
    A plant extract from the smilax glabra tuber root. It may be used as a natural flavoring agent or traditional herbal ingredient to enhance taste or provide botanical character to the medicine.
  • UNII IYR6K8KQ5K
    A plant extract from sophora flavescens root used as a natural colorant and flavoring agent in medicines. It may also help preserve the product and provide texture.
  • 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.
  • UNII F84709P2XV
    Wormwood is a plant extract used as a flavoring agent in medicines. It provides a bitter taste to help mask other flavors or make the medication easier to take.

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

The official label also statesWater, Artemisia Extract, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit Extract, Kochia Scoparia Fruit Extract, Dictamnus Dasycarpus Root Extract, Smilax Glabra Root Extract

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via 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

LabelerRoyceDerm LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85424
First marketedSep 2026
Product typeHuman Otc Drug
Portfolio31 products on file

More NDCs from RoyceDerm LLC labeler code 85424

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 71 words ▾

Wash affected area well andlet product sit 2-3 minutes before rinsing. Make sure todry affected area thoroughly. Supervise children in the useof this product. For Athlete's foot: pay special attention tothe spaces between the toes;wear well-fitting, ventilated shoes and change shoes and socks at least once daily. Use1-2 times daily. Use daily for 4weeks; if condition persists longer, ask a doctor. This product is not effective on the scalp or nails.

⏱️ Dosage and Administration 23 words ▾

For effective treatment of most athlete's foot(tinea pedis), ringworm(tinea corporis) and jock itch(tinea cruris). For effective relief of itching, burning and cracking skin.

⚠️ Warnings 60 words ▾

For external use only. Avoid contact with the eye. Ask a doctor if irritation occurs or if there is no improvement within 2 weeks for athlete's foot and ringworm. Do not use on children under 2 of age except under the advice and supervision of a doctor. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 3 words ▾

Miconazole nitrate 2%

🧪 Inactive Ingredients 23 words ▾

Water, Artemisia Extract, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit Extract, Kochia Scoparia Fruit Extract, Dictamnus Dasycarpus Root Extract, Smilax Glabra Root Extract

🎯 Purpose 1 words ▾

Antifungal

📄 Do Not Use 18 words ▾

Do not use on children under 2 of age except under the advice and supervision of a doctor.

📄 When Using This Product 5 words ▾

Avoid contact with the eye.

📄 Stop Use and Ask a Doctor If 20 words ▾

Ask a doctor if irritation occurs or if there is no improvement within 2 weeks for athlete's foot and ringworm.

📄 Keep Out of Reach of Children 13 words ▾

If swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 6 words ▾

Store at room temperature 59°-86°F (15°-30°C)

📄 Questions or Comments 3 words ▾

Visit w.roycederm.com Tel:+1(307)461-0958

📄 Package Label / Principal Display Panel 2 words ▾

package package

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

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 RoyceDerm LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
RoyceDerm LLC 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.
← 85424-0030-01 · RoyceDerm 85425-0202-50 · Skin →
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.