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Hermon Antifungal Jock Itch Body Wash Tolnaftate 1% 5 g/500g Gel, 500 g — NDC 85398-016-01 (Billing 85398-0016-01)

by Beautivity LLC · 500 g in 1 BOTTLE

This is a package of 500 g of Hermon Antifungal Jock Itch Body Wash Tolnaftate 1% 5 g/500g Gel from Beautivity LLC, marketed since Oct 2025 and currently FDA-listed. It is this product's only package size.

NDC 85398-0016-01
🏷️ FDA NDC (as labeled) 85398-016-01 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 Jul 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85398-016-01
Product NDC 85398-016
11-digit billing NDC 85398001601
RxCUI 2689792
UNII 06KB629TKV
UPC 0199284140288
Application # M005
SPL Set ID 409ef5c0-dfe5-f26a-e063-6294a90a2745
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-31
Route TOPICAL
Dosage form GEL
Substance TOLNAFTATE
Quick answers
  • RxCUI (RxNorm): 2689792
Why two NDCs? The FDA registers this code as 85398-016-01 — 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 → 85398-0016-01. 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.

Clinical

📗 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.
📖 Read our full Tolnaftate 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
85398-0016-01 You're viewing this Main listing 500 g in 1 BOTTLE 2025-10-31 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Antifungal Medicated Body Wash 1 g/100g 83004-0012-01 Rida 56 g — — FDA listed —
Terramed Just Think Comfort Armor Antifungal Body Wash Tea Tree 1 g/100g 83004-0032-01 Rida 56 g — — FDA listed —
Terramed Just Think Comfort Armor Antifungal Body Wash Lavender and chamomile 1 g/100mL 83004-0035-01 Rida 500 ml — — FDA listed —
Terramed Just Think Comfort Armor Antifungal Body Wash Citrus 1 g/100mL 83004-0036-01 Rida 500 ml — — FDA listed —
Terramed Just Think Comfort Armor Antifungal Body Wash Icy Cool Menthol 1 g/100mL 83004-0037-01 Rida 500 ml — — FDA listed —
Quali Life ANTIFUNGAL TEA TREE 1 g/100g 83566-0611-01 Guangdong 300 g — — FDA listed —
Seebeellar Tolnaftate 1% Antifungal Body Wash 1 g/100mL 84558-0016-01 GUANGZHOU 300 ml — — FDA listed —
Hermon Antifungal Jock Itch Body Wash 5 g/500gthis 85398-0016-01 Beautivity 500 g — — FDA listed —
Hermon Ringworm Treatment Body Wash 5 g/500g 85398-0028-01 Beautivity 1 bottle — — FDA listed —
RoyceDerm Tea Tree Body Wash 1 g/100g 85424-0002-01 RoyceDerm 500 g — — FDA listed —
RoyceDerm CoolDefense Refreshing Shower Gel 1 g/100mL 85424-0007-01 RoyceDerm 2 bottles — — FDA listed —
Kopa Haiku Antifungal Soap. 10 mg/g 87041-0007-01 Trovina 125 g — — FDA listed —
Kdman 1 g/100g 87723-6625-01 Dongguan 200 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

🏛️
2025
On the market since
Oct 2025
📍
2026
Currently FDA-listed
1 year 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.

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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • 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 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • UNII 8U5D034955
    Calcium disodium EDTA is a chemical compound that binds to metal ions. It's used in medicines as a stabilizer to prevent discoloration and maintain ingredient freshness during storage.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 79G1T427CF
    A foaming and cleansing agent derived from coconut oil. It's used in topical products as a thickener and to help create lather or improve how the formula spreads on skin.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII MBK0CP8F5A
    Disodium cocoyl glutamate is a mild cleanser derived from coconut oil and amino acids. It acts as a surfactant and emulsifier in medicines, helping to mix oil and water-based ingredients together and improve how the product spreads or absorbs.
  • 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 8FP93ED6H2
    Witch hazel is a plant extract made from the leaves and twigs of the witch hazel shrub. In medicines, it works as a soothing and astringent ingredient that helps reduce inflammation and tighten skin.
  • UNII 1394NXB9L6
    A plant-derived protein from soybeans that has been broken down into smaller pieces using enzymes. It acts as a binder and texture agent, helping hold ingredients together and improve the product's consistency and mouthfeel.
  • UNII 5307V7XW8I
    A beneficial bacterium added to certain medicines and supplements. It acts as a probiotic ingredient, helping maintain or restore healthy gut bacteria balance in formulations designed for digestive wellness.
  • UNII 76LN7P7UCU
    Lauryl glucoside is a mild plant-based cleansing agent made from coconut oil and glucose. It's used in medicines as a surfactant to help dissolve and distribute ingredients evenly throughout the formulation.
  • 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 A4IWO4DDZ9
    A plant extract from spearmint leaves, used as a flavoring agent and to add a cooling, refreshing taste to medicines. It may also have mild soothing properties in the formulation.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII SLK428451L
    Sodium lauroamphoacetate is a mild cleaning agent derived from coconut oil. It acts as a surfactant and emulsifier in medicines, helping blend water and oil-based ingredients together and improving how the product spreads or dissolves.
  • UNII 632GS99618
    Sodium lauroyl sarcosinate is a mild, plant-derived cleaning agent used in medicines as a surfactant and emulsifier. It helps mix oil and water-based ingredients and may aid tablet disintegration.
  • UNII B8WCK70T7I
    Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective during storage.

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

The official label also statesAqua, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine, Lauryl Glucoside, Sodium Lauroamphoacetate, Cocamide Methyl MEA,Disodium Cocoyl Glutamate, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride,Trehalose, Phenoxyethanol, Panthenol, Hamamelis virginiana (Witch Hazel) Water, Aloe Barbadensis Leaf Extract, Sodium Benzoate,Menthol, Arginine, Mentha Arvensis Leaf Extract, Lactobacillus/Rice Ferment, Hydrolyzed OatProtein, Allantoin, Citric Acid, Disodium EDTA,Hydrolyzed Sodium Hyaluronate.

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

LabelerBeautivity LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85398
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio36 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 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
🎯 Indications and Usage 63 words ▾

Use daily in the shower or bath Apply to affected area and surrounding skin Lather and leave on skin for 1-2 minutes, thenrinse thoroughly Dry affected area completely For jock itch and ringworm, use twice daily for 2 weeks For athlete's foot, use twice daily for 4 weeks To help prevent recurrence, continue use after symptoms disappear or as directed by a doctor

⏱️ Dosage and Administration 29 words ▾

Treats most jock itch, athlete's foot, and ringworm Relieves itching, burning, cracking,and discomfort associated with fungal infections Helps prevent recurrence of jock itch and athlete's foot with daily use

⚠️ Warnings 68 words ▾

For external use only Avoid contact with eyes. lf contact occurs, rinse thoroughly with water Do not use onbroken or severely irritated skin Do not apply over large areas of the body lrritation occurs No improvement is seen within 2 weeks (for jock itch and ringworm) No improvement is seen within 4 weeks (for athlete's foot) If swallowed, get medical help or contact aPoison Control Center right away.

🧪 Active Ingredient 2 words ▾

Tolnaftate 1%

🧪 Inactive Ingredients 53 words ▾

Aqua, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine, Lauryl Glucoside, Sodium Lauroamphoacetate, Cocamide Methyl MEA,Disodium Cocoyl Glutamate, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride,Trehalose, Phenoxyethanol, Panthenol, Hamamelis virginiana (Witch Hazel) Water, Aloe Barbadensis Leaf Extract, Sodium Benzoate,Menthol, Arginine, Mentha Arvensis Leaf Extract, Lactobacillus/Rice Ferment, Hydrolyzed OatProtein, Allantoin, Citric Acid, Disodium EDTA,Hydrolyzed Sodium Hyaluronate.

🎯 Purpose 1 words ▾

Antifungal

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 Hermon Antifungal Jock Itch Body Wash (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.

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 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 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.
← 85398-0015-01 · Beautivity 85398-0017-01 · Beautivity →
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.