Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Tinactin Antifungal Tolnaftate 10 mg/g Aerosol, Powder, 133 g — NDC 11523-4162-1 (Billing 11523-4162-01)
by Bayer HealthCare LLC. · 133 g in 1 CAN
This is a package of 133 g of Tinactin Antifungal Tolnaftate 10 mg/g Aerosol, Powder from Bayer HealthCare LLC., marketed since Feb 2014 and currently FDA-listed. It is this product's only package size.
NDC 11523-4162-01
🏷️ FDA NDC (as labeled)
11523-4162-1
billing pads the package segment with a zero
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
Past resolved recalls for this product (2)
Class II · Oct 1, 2021 · Terminated — cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene. (Bayer Healthcare Pharmaceuticals Inc.) · FDA recall D-0242-2022
Class I · Oct 1, 2021 · Terminated — Chemical Contamination: presence of benzene (Bayer Healthcare Pharmaceuticals Inc.) · FDA recall D-0250-2022
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
11523-4162-1
Product NDC
11523-4162
11-digit billing NDC
11523416201
UNII
06KB629TKV
UPC
0311017410004
Application #
M005
SPL Set ID
5f95be36-6efa-4dfb-9a40-88f4ce1de2b3
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2014-02-28
Route
TOPICAL
Dosage form
AEROSOL, POWDER
Substance
TOLNAFTATE
Quick answers
- RxCUI (RxNorm): 705934
Why two NDCs?
The FDA registers this code as 11523-4162-1 — 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 → 11523-4162-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Other antifungals for topical use class.
Drug family (ATC)
Other antifungals for topical use
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
📖 What it is MedlinePlus · NLM
Tolnaftate stops the growth of fungi that cause skin infections, including athlete's foot, jock itch, and ringworm. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- It treats fungal skin infections like athlete's foot, ringworm and, in some products, jock itch. Many products also help prevent athlete's foot. Some are made for skin around the n...
- Wash and dry the area well, then apply a thin layer. Most products are used twice a day, morning and night. The length of use varies, often 4 weeks for athlete's foot and ringworm,...
- The main one is skin irritation. If that happens, stop using it and talk to a doctor.
- Call if you see no improvement within 4 weeks for athlete's foot or ringworm, or 2 weeks for jock itch. Call if irritation develops. Call right away if anyone swallows it.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Tolnaftate — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Tolnaftate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 11523-4162-01 You're viewing this Main listing | 133 g in 1 CAN | 2014-02-28 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tolnafate 1.3 g/130g 70000-0322-01 | LEADER/ | 130 g | $0.033 | — | Availability likely | — |
| Athletes Foot 10 mg/g 00536-1481-01 | Rugby | 130 g | $0.033 | — | Availability likely | — |
| Tolnaftate 1.3 g/113g 00363-0216-13 | Walgreen | 113 g | — | — | FDA listed | — |
| Tolnaftate 1.3 g/130g 00363-1746-00 | Walgreens | 130 g | — | — | FDA listed | — |
| Blistex Odor-Eaters Powder 1 g/100g 10157-4645-01 | Blistex | 113 g | — | — | FDA listed | — |
| Lotrimin Daily Prevention Deo 10 mg/g 11523-0010-01 | Bayer | 160 g | — | — | FDA listed | — |
| Lotrimin Daily Prevent Deodorant 10 mg/g 11523-0136-01 | Bayer | 160 g | — | — | FDA listed | — |
| Tinactin Deodorant 10 mg/g 11523-0137-01 | Bayer | 133 g | — | — | FDA listed | — |
| Tinactin Jock Itch 10 mg/g 11523-0138-01 | Bayer | 133 g | — | — | FDA listed | — |
| Tinactin 10 mg/g 11523-0139-01 | Bayer | 133 g | — | — | FDA listed | — |
| Tinactin Antifungal 10 mg/gthis 11523-4162-01 | Bayer | 133 g | — | — | FDA listed | — |
| Tolnaftate 1.3 g/130g 11822-0782-04 | Rite | 130 g | — | — | FDA listed | — |
| Kerasal Athletes Foot powder 1 g/100g 16864-0110-01 | Advantice | 57 g | — | — | Discontinued | — |
| Tolnafate 1.3 g/130g 21130-0215-00 | Better | 130 g | — | — | FDA listed | — |
| GoodSense Powder Jock Itch Antifungal 10 mg/g 23667-0806-01 | Formulated | 130 g | — | — | Discontinued | — |
| Walgreens Maximum Strength Jock Itch Antifungal 10 mg/g 23667-0807-01 | Formulated | 130 g | — | — | Discontinued | — |
| Meijer Maximum Strength Jock Itch Relief Antifungal 10 mg/g 23667-0809-01 | Formulated | 130 g | — | — | Discontinued | — |
| Meijer Maximum Strength Anthletes foot Antifungal 10 mg/g 23667-0810-01 | Formulated | 130 g | — | — | Discontinued | — |
| Signature Athletes Foot Antifungal 10 mg/g 23667-0814-01 | Formulated | 130 g | — | — | Discontinued | — |
| Walgreens Medicated Antifungal Athletes Foot 10 mg/g 23667-0818-01 | Formulated | 130 g | — | — | Discontinued | — |
| Tolnaftate 1.3 g/130g 30142-0841-01 | Kroger | 130 g | — | — | FDA listed | — |
| Tolnaftate 1.13 g/113g 36800-0023-04 | Topco | 113 g | — | — | FDA listed | — |
| Tolnafate 1.3 g/130g 36800-0876-46 | Topco | 130 g | — | — | FDA listed | — |
| Tolnaftate 1.3 g/130g 36800-0877-46 | Topco | 130 g | — | — | FDA listed | — |
| Tolnaftate 1.13 g/113g 37808-0514-40 | HEB | 113 g | — | — | FDA listed | — |
| Tolnafate 1.3 g/130g 37808-0530-46 | HEB | 130 g | — | — | FDA listed | — |
| Tolnaftate 1.3 g/130g 41250-0563-46 | Meijer | 130 g | — | — | Discontinued | — |
| Tolnaftate 1.13 g/113g 41520-0086-04 | Foodhold | 113 g | — | — | FDA listed | — |
| Derman Antifungal 10 mg/g 54312-0230-01 | Compania | 130 g | — | — | FDA listed | — |
| Antifungal Powder 10 mg/g 55301-0874-01 | ARMY | 130 g | — | — | FDA listed | — |
| Fungi Nail Everyday Antifungal Powder 1.3 g/130g 55505-0234-81 | Kramer | 130 g | — | — | FDA listed | — |
| Hongo Killer .1 g/10g 58593-0285-04 | Efficient | 130 g | — | — | FDA listed | — |
| Tolnafate 1.3 g/130g 63868-0181-46 | Chain | 130 g | — | — | FDA listed | — |
| Tolnafate 1.3 g/130g 63941-0540-46 | VALU | 130 g | — | — | FDA listed | — |
| Tolnafate 1.3 g/130g 63941-0541-46 | VALU | 130 g | — | — | FDA listed | — |
| Tolnafate 1.3 g/130g 68016-0653-46 | Chain | 130 g | — | — | FDA listed | — |
| Tolnafate 1.3 g/130g 68016-0663-46 | Chain | 130 g | — | — | FDA listed | — |
| Tolnafate 1.3 g/130g 69842-0512-46 | CVS | 130 g | — | — | FDA listed | — |
| Tolnafate 10 mg/g 79481-0607-01 | Meijer | 130 g | — | — | FDA listed | — |
| Foot Odor Control Powder 10 mg/g 79481-0622-01 | Meijer | 113 g | — | — | FDA listed | — |
| Tolnafate 10 mg/g 79481-0623-01 | Meijer | 130 g | — | — | FDA listed | — |
| Tolnafate 1.3 g/130g 79903-0016-46 | Wal-Mart | 130 g | — | — | FDA listed | — |
| Derman Antifungal Powder Tolnaftate 10 mg/g 81929-0001-01 | Taisho | 1 can | — | — | FDA listed | — |
| Tolnaftate 10 mg/g 82442-0402-01 | Target | 113 g | — | — | FDA listed | — |
| Tolnafate 10 mg/g 83324-0234-46 | Chain | 130 g | — | — | FDA listed | — |
| Tinactin 10 mg/g 11523-0165-03 | Bayer | 150 g | — | — | FDA listed | — |
| Antifungal Liquid 10 mg/g 46122-0839-35 | AmerisourceBergen | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2014
On the market since
Feb 2014
📍
2026
Currently FDA-listed
12 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.
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Color
white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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 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 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 58CG7042J1
A synthetic liquid polymer made from propylene glycol and fatty alcohol components. It functions as an emulsifier and solubilizer, helping mix oil and water-based ingredients and keep them blended throughout the product's shelf life.
-
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
4 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesButylated Hydroxytoluene, Fragrance, Isobutane, PPG-12-Buteth-16, SD Alcohol 40-B (10.5% v/v),Talc
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerBayer HealthCare LLC.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code11523
First marketedFeb 2014
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) helps prevent most athlete's foot with daily use for effective relief of itching, burning and cracking
⏱️ Dosage and Administration ▾
Directions wash the 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 for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily use daily for 4 weeks; if condition persists longer, ask a doctor to prevent athlete's foot, apply once or twice daily (morning and/or night) this product is not effective on the scalp or nails
⚠️ Warnings ▾
Warnings 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 the contents can be harmful or fatal. contents under pressure. do not puncture or incinerate. Do not store at temperatures above 120°F.
Stop use and ask a doctor if irritation occurs there is no improvement within 4 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 ingredients (To Deliver) Tolnaftate 1%
🧪 Inactive Ingredients ▾
Inactive Ingredients Butylated Hydroxytoluene, Fragrance, Isobutane, PPG-12-Buteth-16, SD Alcohol 40-B (10.5% v/v),Talc
🎯 Purpose ▾
Purpose Antifungal
📄 Do Not Use ▾
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 ▾
When using this product avoid contact with the eyes use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. contents under pressure. do not puncture or incinerate. Do not store at temperatures above 120°F.
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📄 Questions or Comments ▾
Questions? 1-866-360-3266
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 133 g Can Label NDC 11523-4162-1 TOUGH ACTIN' ® Tinactin ® ANTIFUNGAL tolnaftate Cures and prevents most athlete's foot DEODORANT POWDER SPRAY fights odor all day Relieves itching & burning NET WT 133g (4.6 oz) Can image
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 ↗
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 Tinactin Antifungal (this brand).
Top reported reactions
Reporter sex
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.
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 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.
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.