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Clotrimazole antifungal treatment kit Clotrimazole 1% Kit — NDC 85398-0012-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Clotrimazole antifungal treatment kit Clotrimazole 1% Kit — NDC 85398-012-01 (Billing 85398-0012-01)

by Beautivity LLC · 1 KIT in 1 CARTON * 57 g in 1 BOTTLE * 116 g in 1 CARTON

This is a package of Clotrimazole antifungal treatment kit Clotrimazole 1% Kit from Beautivity LLC, marketed since Aug 2025 and currently FDA-listed. It is this product's only package size.

NDC 85398-0012-01
🏷️ FDA NDC (as labeled) 85398-012-01 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) 85398-012-01
Product NDC 85398-012
11-digit billing NDC 85398001201
RxCUI 251267, 309367
UPC 0199284897021
Application # M005
SPL Set ID 3ceec52e-4089-9eb0-e063-6294a90ad52a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-08-31
Route TOPICAL
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 251267
Why two NDCs? The FDA registers this code as 85398-012-01 — 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 → 85398-0012-01. 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 and triazole derivatives, Imidazole 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.

Clinical

🧪 What is this product?

This is an over-the-counter topical antifungal treatment kit containing clotrimazole 1%. Clotrimazole is an antifungal medication typically used to treat fungal infections of the skin, such as athlete's foot, jock itch, and ringworm. The kit format allows the product to include applicators or additional items to help with application. As an OTC monograph drug, it is marketed under FDA guidelines for this category of antifungal products.

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85398-0012-01 You're viewing this Main listing 1 KIT in 1 CARTON * 57 g in 1 BOTTLE * 116 g in 1 CARTON 2025-08-31 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
TM-Clotrimazole 1 g/100g 83035-1062-03 Singular 1 tube $0.118 — Availability likely —
Publix Athletic Foot 10 mg/g 56062-0817-28 PUBLIX 1 tube — — FDA listed —
FifthPulse Clotrimazole Cream 1oz 1 g/100g 69571-0020-01 Front 28.4 g — — FDA listed —
Clotrimazole antifungal treatment kitthis 85398-0012-01 Beautivity 1 kit — — FDA listed —
Hermon Clotrimazole antifungal soap. bar 1.16 g/116g 85398-0011-01 Beautivity 116 g — — FDA listed —
Up and Up Athletes Foot 10 mg/g 82442-0022-28 Target 1 tube — — FDA listed —
Oiangna Tea Tree Oil Antifungal 1 g/116g 87204-0285-01 Guangzhou 116 g — — FDA listed —
FifthPulse clotrimazole cream 4oz 1 g/100g 69571-0019-01 Front 113.4 g — — FDA listed —
Hermon Clotrimazole antifungal treatment cream .57 g/57g 85398-0010-01 Beautivity 57 g — — FDA listed —
Hermon Ringworm Antifungal soap. 2.3 g/230g 85398-0026-01 Beautivity 230 g — — FDA listed —
RoyceDerm ANTIFUNGAL .soap. 2.26 g/226g 85424-0019-01 RoyceDerm 226 g — — FDA listed —
Terthon Clotrimazole 1% Antifungal Cream 1 g/100g 85849-0010-01 SOLALIA 30 g — — FDA listed —
Target Jock Itch 10 mg/g 11673-0893-14 Target 1 tube — — FDA listed —
RoyceDerm Tinea ANTIFUNGAL .soap. 2.26 g/226g 85424-0022-01 RoyceDerm 226 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.

From the label’s inactive-ingredient sectionFor cream: Purifed Water, White Petrolatum, Mineral Oil, Glycerol, Cetostearyl Alcohol, Glyceryl Mono-And Distearate, Dimethyl sulfoxide, Alcohol, Polyoxyethylene Lauryl Ether (Peregal 0), Edetate Disodium, Butylated Hydroxytoluene, Ethylparaben For soap: Melaleuca Alternifalla (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Olil, Cocos Nucifera (Coconut) Olil,Olea Europaea (0live) Fruit Oi, Propylene Glycol, Glycerin, stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur Thermal Water, Hamamelis Virginiana (WitchHazel)Extract, Ceramide

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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

LabelerBeautivity LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85398
First marketedAug 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 60 words ▾

For cream Wash affected area & dry thoroughly. Apply a thin layer over affected area twice dally (morning andnight). Supervise children in the use of this product. Use daily for 2 weeks. For soap Wet skin with warm water and lather soap. Gently massage onto affected areas. Rinse thoroughly and dry. Use twice daily or as directed by a doctor.

⏱️ Dosage and Administration 35 words ▾

Proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tineacorporis). For effective relief of itching, irritation, redness, scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.

⚠️ Warnings 54 words ▾

For external use only. Do not use on children under 2 years of age unless directed by a doctor. avoide contact with eyes, lf contact occurs, rinse thoroughly with water. irritation occurs or if there is no improvement within 2 weeks. lf swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 11 words ▾

Store at room temperature. Protect from excessive heat (above 104°F/ 40°C)

🧪 Active Ingredient 2 words ▾

Clotrimazole 1%

🧪 Inactive Ingredients 75 words ▾

For cream: Purifed Water, White Petrolatum, Mineral Oil, Glycerol, Cetostearyl Alcohol, Glyceryl Mono-And Distearate, Dimethyl sulfoxide, Alcohol, Polyoxyethylene Lauryl Ether (Peregal 0), Edetate Disodium, Butylated Hydroxytoluene, Ethylparaben For soap: Melaleuca Alternifalla (Tea Tree) Leaf Oil, Aqua (Water), Sorbitol, Elaeis Guineensis (Palm) Olil, Cocos Nucifera (Coconut) Olil,Olea Europaea (0live) Fruit Oi, Propylene Glycol, Glycerin, stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzene Sulfonate, Sulfur Thermal Water, Hamamelis Virginiana (WitchHazel)Extract, Ceramide

🎯 Purpose 1 words ▾

Antifungal

📄 Do Not Use 15 words ▾

Do not use on children under 2 years of age unless directed by a doctor.

📄 Ask a Doctor Before Use If 11 words ▾

irritation occurs or if there is no improvement within 2 weeks.

📄 When Using This Product 11 words ▾

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

📄 Keep Out of Reach of Children 13 words ▾

lf swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 4 words ▾

visit us at www.hermonhealth.com

📄 Package Label / Principal Display Panel 1 words ▾

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 Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 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.
← 85398-0011-01 · Beautivity 85398-0013-01 · 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.