HomeNDC LookupIngredientsMiconazole Nitrate Cream › 87306-0126-01
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RoMMY Jean-Pierre LLC Anti-fungal Cream Miconazole Nitrate 1 g/100g; 1 g/100g; 2 g/100g; 5 g/100g Cream, 113.4 g

by RoMMY Jean-Pierre LLC · 113.4 g in 1 JAR (87306-126-01)
NDC 87306-0126-01
🏷️ FDA NDC (as labeled) 87306-126-01 billing pads the product segment with a zero
This package
Contains113.4 g Pack sizes2 compare ↓
Also comes in: 56.7 g 87306-0126-02
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ 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 →
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2027. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 87306-126-01
Product NDC 87306-126
11-digit billing NDC 87306012601
UNII 5TJD82A1ET, L7T10EIP3A, VW4H1CYW1K, 70FD1KFU70
Application # M005
SPL Set ID 4a533c14-3fe2-9ee7-e063-6294a90a3fe6
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2027)
Marketing start 2026-02-08
Route TOPICAL
Dosage form CREAM
Substance CAMPHOR (SYNTHETIC); MENTHOL; MICONAZOLE NITRATE; SULFUR
Why two NDCs? The FDA registers this code as 87306-126-01 — 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 → 87306-0126-01. 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.

🏭 Manufacturer & labeler

LabelerRoMMY Jean-Pierre LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code87306
First marketedFeb 2026
Product typeHuman Otc Drug
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 is this product?

This is a topical cream marketed as an over-the-counter antifungal product under FDA's OTC monograph rules. It contains miconazole nitrate, an ingredient typically used to treat fungal skin infections, along with menthol and camphor, which are commonly included in topical products for their cooling and soothing sensations. The formula also includes sulfur, a substance often used in skincare products for fungal and bacterial concerns. The cream is applied directly to the skin.

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 RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • 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 65UEH262IS
    Safflower oil is a plant-based oil extracted from safflower seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and sometimes as an emollient to improve texture.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • 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 3J50XA376E
    Thymol is a natural compound derived from thyme and other plants. It acts as a preservative and flavoring agent in medicines, helping prevent microbial growth and add taste.

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

The official label also statesAloe barbadensis leaf juice, carthamus tinctorius (safflower) seed oil, petrolatum, peppermint oil, thymol, alpha-tocopherol acetate

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.
Try another pack size: 56.7 g
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
RoMMY Jean-Pierre LLC Anti-fungal Cream 1 g/100g; 1 g/100g; 2 g/100g; 5 g/100gthis 87306-0126-01 RoMMY 113.4 g Discontinued
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
Feb 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.

🔬 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 Cream — the ingredient across all brands.

Top reported reactions

Genital Swelling1
Product Formulation Issue1
Vulvovaginal Burning Sensation1
Vulvovaginal Pruritus1

Reporter sex

1 reports
Female · 100%
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
87306-0126-01 You're viewing this 113.4 g in 1 JAR (87306-126-01) 2026-02-08 Inactivated by FDA
87306-0126-02 56.7 g in 1 JAR (87306-126-02) 2026-02-08 Inactivated by FDA

Pack size FAQ

What quantity is in NDC 87306-0126-01?
NDC 87306-0126-01 contains 113.4 g — 113.4 g in 1 jar.
What is the difference between NDC 87306-0126-01 and NDC 87306-0126-02?
Both are RoMMY Jean-Pierre LLC Anti-fungal Cream Miconazole Nitrate 1 g/100g; 1 g/100g; 2 g/100g; 5 g/100g Cream — the drug itself is identical. NDC 87306-0126-01 is the 113.4 g package, while NDC 87306-0126-02 is the 56.7 g package.
What NDC number is used to bill for this package of RoMMY Jean-Pierre LLC Anti-fungal Cream Miconazole Nitrate 1 g/100g; 1 g/100g; 2 g/100g; 5 g/100g Cream?
Bill NDC 87306-0126-01 — the 11-digit billing format is 87306012601. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 87306-126-01, 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: 87306-0126-01, written without dashes as 87306012601. 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 87306-0126-01, the first segment (87306) is the labeler code FDA assigned to RoMMY Jean-Pierre LLC; the middle segment (0126) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 56.7 g (87306-0126-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
RoMMY Jean-Pierre 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.

📄 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 37 words

Cures most athlete’s foot, jock itch, and ringworm Relieves itching, burning, cracking, and scaling associated with these conditions Helps relieve itching and discomfort associated with minor skin irritation Helps loosen and remove excessive dead skin and flakes

⏱️ Dosage and Administration 46 words

Clean and dry the affected area before applying Apply a thin layer to the affected area twice daily (morning and night) 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

⚠️ Warnings 73 words

For external use only Do not use on children under 2 years of age unless directed by a doctor When using this product avoid contact with eyes do not apply to broken or severely irritated skin Stop use and ask a doctor if: irritation occurs condition worsens symptoms persist for more than 4 weeks Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 19 words

Store at 20°–25°C (68°–77°F) Excursions permitted between 15°–30°C (59°–86°F) Protect from excessive heat and direct sunlight Do Not Freeze

🧪 Active Ingredient 11 words

Active ingredients Miconazole nitrate 2% Sulfur 5% Camphor 1% Menthol 1%

🧪 Inactive Ingredients 15 words

Aloe barbadensis leaf juice, carthamus tinctorius (safflower) seed oil, petrolatum, peppermint oil, thymol, alpha-tocopherol acetate

🎯 Purpose 5 words

Purpose Antifungal Keratolytic External Analgesic

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.