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RoyceDerm Tea Tree Body Wash 1 g/100g Gel, 500 g — NDC 85424-002-01 (Billing 85424-0002-01)

by RoyceDerm LLC · 500 g in 1 BOTTLE

This is a package of 500 g of RoyceDerm Tea Tree Body Wash 1 g/100g Gel from RoyceDerm LLC, marketed since Aug 2025 and currently FDA-listed. It is this product's only package size.

NDC 85424-0002-01
🏷️ FDA NDC (as labeled) 85424-002-01 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 Jun 25, 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) 85424-002-01
Product NDC 85424-002
11-digit billing NDC 85424000201
RxCUI 2689792
UNII 06KB629TKV
UPC 0860009297029
Application # M005
SPL Set ID 3a2bb86e-36a2-2cd7-e063-6394a90a3fb4
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-01
Route TOPICAL
Dosage form GEL
Substance TOLNAFTATE
Quick answers
  • RxCUI (RxNorm): 2689792
Why two NDCs? The FDA registers this code as 85424-002-01 — 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 → 85424-0002-01. 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
85424-0002-01 You're viewing this Main listing 500 g in 1 BOTTLE 2025-08-01 — 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/500g 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/100gthis 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
Aug 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerRoyceDerm LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85424
First marketedAug 2025
Product typeHuman Otc Drug
Portfolio31 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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 23 words ▾

Helps relieve and prevent athlete's foot(tinea pedis), jock itch (tinea cruris),ringworm(tinea corporis) Relieves itching, cracking, scaling, and discomfort caused by these fungal infections

⏱️ Dosage and Administration 68 words ▾

Apply to body and feet during shower or bath. Gently massage over the entire body,focusing on areas where odor or skin irritation is a concern. After gently washing, rinseand dry skin and feet thoroughly. For Athllete'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. This product is not effective on the scalp or nails.

⚠️ Warnings 95 words ▾

For external use only on children under 12 of age except under the advice and supervision of a doctor. Ask a doctor before use if allergic to anyingredients in this product. avoid contact with eyes. lf contact occurs, rinse eyes thoroughly with water. 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. ask a health professional before use In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

🧪 Active Ingredient 2 words ▾

Tolnaftate 1.0%

🧪 Inactive Ingredients 32 words ▾

Purified Water, Artemisia Argyi Leaf, TeaTree Oil, Shea Butter, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit,Lentinula Edodes (Shiitake Mushroom)Extract, Gleditsia Sinensis Fruit, Typhonium Giganteum Whole, Stemona Tuberosa Root, Citric Acid, Amino Acids

🎯 Purpose 1 words ▾

Anti-Fungal

📄 Do Not Use 15 words ▾

on children under 12 of age except under the advice and supervision of a doctor.

📄 Ask a Doctor Before Use If 12 words ▾

Ask a doctor before use if allergic to anyingredients in this product.

📄 When Using This Product 12 words ▾

avoid contact with eyes. lf contact occurs, rinse eyes thoroughly with water.

📄 Stop Use and Ask a Doctor If 29 words ▾

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.

🤰 If Pregnant or Breast-Feeding 6 words ▾

ask a health professional before use

📄 Keep Out of Reach of Children 17 words ▾

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

📄 Other Information 12 words ▾

Store at 20° to 25°C(68° to 77°F) and out of direct sunlight.

📄 Questions or Comments 2 words ▾

Email [email protected]

📄 Package Label / Principal Display Panel 3 words ▾

body wash package

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 RoyceDerm LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
RoyceDerm 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.
← 85424-0001-01 · RoyceDerm 85424-0003-01 · RoyceDerm →
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.