HomeNDC LookupIngredientsTolnaftate 1% › 85398-0029-01
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Hermon Antifungal Cleansing Bar tolnaftate 1% 4.52 g/452g Soap, 452 g

by Beautivity LLC · 452 g in 1 CARTON (85398-029-01)
NDC 85398-0029-01
🏷️ FDA NDC (as labeled) 85398-029-01 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 →

🆔 Identity & classification

FDA NDC (as labeled) 85398-029-01
Product NDC 85398-029
11-digit billing NDC 85398002901
RxCUI 1807715
UNII 06KB629TKV
UPC 0199874564289
Application # M005
SPL Set ID 48b5d7b3-a134-ecdd-e063-6294a90a3213
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-02
Route TOPICAL
Dosage form SOAP
Substance TOLNAFTATE
Why two NDCs? The FDA registers this code as 85398-029-01 — 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 → 85398-0029-01. 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 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.

🏭 Manufacturer & labeler

LabelerBeautivity LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85398
First marketedFeb 2026
Product typeHuman Otc Drug
Portfolio34 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

📗 Our plain-language guide HelloPharmacist
  • It depends on what you're treating. For athlete's foot and ringworm, plan on using it daily for about 4 weeks. For jock itch, 2 weeks is the usual course. Some products mention you...
  • How long does it take for tolnaftate to work?
  • Tolnaftate is not effective for treating infections on the scalp or on the nails themselves — most products say so right on the label. Some liquid and patch products are designed t...
  • Stop applying the product and let your doctor know. A little initial sensitivity can happen, but worsening irritation is a sign that you should get it checked out. Don't push throu...
📖 Read our full Tolnaftate 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 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 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 K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 1160N9NU9U
    Lauric acid is a natural saturated fatty acid derived from coconut or palm oil. It serves as an emulsifier and lubricant in medicines, helping ingredients mix smoothly and preventing sticking during manufacturing.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII JQ43KP6296
    Sodium palmitate is a salt derived from palmitic acid, a naturally occurring fatty acid. It acts as an emulsifier and surfactant in medicines, helping mix oil and water-based ingredients and improving product stability and texture.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

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

The official label also statesSucrose, Stearic Acid, Propylene Glycol, Sorbitol, Sodium Palmitate, Water(Aqua),Glycerin, Butyrospermum Parkii (Shea) Butter, Lauric Acid,Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis LeafJuice, Cocos Nucifera (Coconut) Oil, Fragrance

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 eachPer 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
Inlifay ANTIFUNGAL 1 g/100g 60771-0040-01 Guangzhou 232 g FDA listed
Defense Antifungal Medicated Bar 1 g/100g 70856-3581-02 Defense 1 not FDA listed
Terramed Just Think Comfort Armor Antifungal Medicated 1 g/100g 83004-0017-01 Rida 120 g FDA listed
Quali Life ANTIFUNGAL PERSIMMON 1 g/100g 83566-0606-01 Guangdong 300 g FDA listed
Quali Life ANTIFUNGAL CHARCOAL 1 g/100g 83566-0607-01 Guangdong 300 g FDA listed
Inlifay ANTIFUNGAL 1 g/100g 83566-0609-01 Guangdong 232 g FDA listed
Tagrid Antifungal 10 mg/g 85384-0010-01 TAGRID 142 g FDA listed
Tagrid Antifungal 10 mg/g 85384-0013-01 TAGRID 113.4 g FDA listed
Athlete Foot Medicated bar 1 g/100g 85398-0007-01 Beautivity 232 g FDA listed
Hermon Antifungal Soap. 10 mg/g 85398-0019-02 Beautivity 226 g FDA listed
Hermon Antifungal Soap. 4 packs 10 mg/g 85398-0020-02 Beautivity 452 g FDA listed
Hermon Antifungal .soap. 10 mg/g 85398-0025-02 Beautivity 226 g FDA listed
Hermon Antifungal Cleansing Bar 4.52 g/452gthis 85398-0029-01 Beautivity 452 g FDA listed
Hermon Jock Itch Antifungal Treatment .Soap. Bar 1.13 g/113g 85398-0031-01 Beautivity 113 g FDA listed
Antifungal Medicated Bar 10 mg/g 85424-0001-01 RoyceDerm 232 g FDA listed
ProBliva Antifungal Scrub .soap. Bar 1.13 g/113g 85464-0007-01 CAVTECH 113 g FDA listed
Lavinso Antifungal 1 g/100g 87011-0102-01 Lavinso 232 g Discontinued
Tea Tree Oil Antifungal Soaps .7 g/70g 87257-0001-01 Nanjing 70 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
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 Hermon Antifungal Cleansing Bar (this brand).

Top reported reactions

Muscular Weakness1

Reporter sex

1 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1 0
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 NDCDescription Marketing startStatus
85398-0029-01 You're viewing this 452 g in 1 CARTON (85398-029-01) 2026-02-02 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 85398-029-01, 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: 85398-0029-01, written without dashes as 85398002901. 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 85398-0029-01, the first segment (85398) is the labeler code FDA assigned to Beautivity LLC; the middle segment (0029) 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 Beautivity LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Beautivity 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 76 words

Wash affected area well and let product sit 2-3 minutes beforerinsing. Make sure to dry affected area thoroughly. Supervisechildren in the use of this product. For Athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily. * Use 1-2 timesdaily. Use daily for 4 weeks; if condition persists longer, ask a doctor. This product is not effective on the scalp or nails.

⏱️ Dosage and Administration 25 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 72 words

For external use only When using this product Avoid contactwith the eye. Stop and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 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 2 words

Tolnaftate 1%

🧪 Inactive Ingredients 30 words

Sucrose, Stearic Acid, Propylene Glycol, Sorbitol, Sodium Palmitate, Water(Aqua),Glycerin, Butyrospermum Parkii (Shea) Butter, Lauric Acid,Sodium Hydroxide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis LeafJuice, Cocos Nucifera (Coconut) Oil, Fragrance

🎯 Purpose 1 words

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.