Lotrimin AF Jock Itch Miconazole nitrate 20 mg/g Aerosol, Powder, 133 g
by Bayer Healthcare LLC. · 133 g in 1 CAN (11523-0133-1)
NDC 11523-0133-01
🏷️ FDA NDC (as labeled)
11523-0133-1
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)
11523-0133-1
Product NDC
11523-0133
11-digit billing NDC
11523013301
RxCUI
998428
UNII
VW4H1CYW1K
Application #
M005
SPL Set ID
0c53cf0f-767e-a422-e063-6394a90ab764
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
2023-11-29
Route
TOPICAL
Dosage form
AEROSOL, POWDER
Substance
MICONAZOLE NITRATE
Why two NDCs?
The FDA registers this code as 11523-0133-1 — 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 → 11523-0133-01. 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
LabelerBayer Healthcare LLC.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code11523
First marketedNov 2023
Product typeHuman Otc Drug
Portfolio240 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?
Patient education
Supplement & herbal interactions
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.
💬 Questions about Miconazole nitrate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 BXR49TP611
Isobutane is a liquefied gas used as a propellant in aerosol inhalers and sprays. It helps push the medicine out of the container so you can breathe or spray it as directed.
-
UNII 24H4NWX5CO
Kaolin is a naturally occurring clay mineral. It's used in tablets and capsules as a filler and absorbent to add bulk, improve texture, and help bind ingredients together.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
-
UNII OLX698AH5P
A clay mineral processed with a quaternary ammonium compound. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also stateshydroxypropyl cellulose, isobutane, kaolin, magnseium stearate, SD alcohol 40-B (8% v/v), stearalkonium hectorite, zea mays (corn) starch
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.
💲 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 system | Per g | Per 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Miconazole Nitrate 2.6 g/130g 70000-0321-01 | Cardinal | 130 g | $0.036 | — | Availability likely | — |
| Miconazole Nitrate 2.6 g/130g 00363-7418-00 | Walgreens | 130 g | — | — | FDA listed | — |
| Lotrimin AF Jock Itch 20 mg/gthis 11523-0133-01 | Bayer | 133 g | — | — | FDA listed | — |
| Lotrimin AF 20 mg/g 11523-0134-01 | Bayer | 133 g | — | — | FDA listed | — |
| Lotrimin AF Deodorant 20 mg/g 11523-0135-01 | Bayer | 133 g | — | — | FDA listed | — |
| Miconazole Nitrate 2.6 g/130g 11822-0135-04 | Rite | 130 g | — | — | FDA listed | — |
| Miconazole Nitrate 2.6 g/130g 21130-0212-00 | Better | 130 g | — | — | FDA listed | — |
| Good Neighbor Pharmacy Jock Itch Relief Antifungal 20 mg/g 23667-0819-01 | Formulated | 130 g | — | — | Discontinued | — |
| Miconazole Nitrate 2.6 g/130g 36800-0384-46 | Topco | 130 g | — | — | FDA listed | — |
| Miconazole Nitrate 2.6 g/130g 41250-0196-46 | Meijer | 130 g | — | — | Discontinued | — |
| Miconazole Nitrate 2.6 g/130g 41520-0565-46 | Foodhold | 130 g | — | — | FDA listed | — |
| Silka Athletes Foot 20 mg/g 50066-0084-46 | Genomma | 130 g | — | — | FDA listed | — |
| Miconazole Nitrate 2.6 g/130g 56104-0121-01 | Premier | 130 g | — | — | FDA listed | — |
| Miconazole Nitrate 2.6 g/130g 56104-0131-46 | Premier | 130 g | — | — | Discontinued | — |
| Miconazole Nitrate 20 mg/g 56104-0907-01 | Premier | 130 g | — | — | FDA listed | — |
| Athletes Foot 20 mg/g 56104-0912-01 | Premier | 130 g | — | — | FDA listed | — |
| HEB Athlete Foot Antifungal 20 mg/g 59640-0101-01 | HEB | 130 g | — | — | FDA listed | — |
| Miconazole Nitrate 2.6 g/130g 63868-0180-46 | Chain | 130 g | — | — | FDA listed | — |
| Miconazole Nitrate 2.6 g/130g 67091-0392-06 | Winco | 130 g | — | — | FDA listed | — |
| Miconazole Nitrate 2.6 g/130g 69256-0039-46 | Harris | 130 g | — | — | FDA listed | — |
| Miconazole Nitrate 2.6 g/130g 69842-0511-46 | CVS | 130 g | — | — | FDA listed | — |
| Antifungal Athletes Foot 20 mg/g 79481-0505-01 | Meijer | 130 g | — | — | FDA listed | — |
| Jock Itch 20 mg/g 79481-0602-01 | Meijer | 130 g | — | — | FDA listed | — |
| Miconazole Nitrate 2.6 g/130g 79903-0014-46 | Wal-Mart | 130 g | — | — | FDA listed | — |
| Miconazole Nitrate 20 mg/g 83324-0233-46 | Chain | 130 g | — | — | FDA listed | — |
| Antifungal Miconazole Liquid Continuous 20 mg/g 79481-0599-01 | Meijer | 150 g | — | — | FDA listed | — |
| Antifungal Liquid Continuous 20 mg/g 55319-0539-01 | Family | 150 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
Nov 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.
📊 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 Lotrimin AF Jock Itch (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 30%
Female · 70%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 11523-0133-01 You're viewing this | 133 g in 1 CAN (11523-0133-1) | 2023-11-29 | 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 | — 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.
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 11523-0133-1, 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: 11523-0133-01, written without dashes as 11523013301. 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 11523-0133-01, the first segment (11523) is the labeler code FDA assigned to Bayer Healthcare LLC.; the middle segment (0133) 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.
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 Bayer Healthcare LLC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bayer Healthcare 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
⏱️ Dosage and Administration
⚠️ Warnings
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses proven clinically effective in the treatment of most jock itch (tinea cruris) for effective relief of itching, burning, scaling and discomfort, and chafing associated with jock itch
⏱️ Dosage and Administration ▾
Directions wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) supervise children in the use of this product use daily for 2 weeks if condition persists longer, ask a doctor this product is not effective on the scalp or nails
⚠️ Warnings ▾
Warnings For external use only Flammable: Do not use while smoking or near heat or flame For external use only Flammable: DO not use near heat, flame, or while smoking Do not use on children under 2 years of age unless directed by a doctor When using this product avoid contact with the eyes use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal contents under pressure. Do not puncture or incinerate.
Do not store at temperature above 120°F. Stop use and ask a doctor if irritation occurs there is no improvement within 2 weeks Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information store between 20° to 25°C (68° to 77°F)
🧪 Active Ingredient ▾
Active ingredient Miconazole nitrate 2%
🧪 Inactive Ingredients ▾
Inactive ingredients hydroxypropyl cellulose, isobutane, kaolin, magnseium stearate, SD alcohol 40-B (8% v/v), stearalkonium hectorite, zea mays (corn) starch
🎯 Purpose ▾
Purpose Antifungal
No label section mentions that — try another word, or open the full label on DailyMed below.
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.