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Tinea Versicolor Treatment Cream Clotrimazole 10 mg/g Cream, 60 g — NDC 85398-0002-01 package photo

Tinea Versicolor Treatment Cream Clotrimazole 10 mg/g Cream, 60 g

by Beautivity LLC · 60 g in 1 TUBE (85398-002-01)
NDC 85398-0002-01
🏷️ FDA NDC (as labeled) 85398-002-01 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Clotrimazole (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0210-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0211-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 85398-002-01
Product NDC 85398-002
11-digit billing NDC 85398000201
RxCUI 309367
UNII G07GZ97H65
Application # M005
SPL Set ID 32d71d7e-3c78-6b63-e063-6294a90adaed
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-12
Route TOPICAL
Dosage form CREAM
Substance CLOTRIMAZOLE
Why two NDCs? The FDA registers this code as 85398-002-01 — 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 → 85398-0002-01. 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 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.

🏭 Manufacturer & labeler

LabelerBeautivity LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code85398
First marketedMay 2025
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

📖 What it is MedlinePlus · NLM

Topical clotrimazole is used to treat tinea corporis (ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Clotrimazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on which product you have. The topical creams, solutions, and sprays treat common fungal skin infections — athlete's foot, jock itch, and ringworm. The CLOTIC ear drops...
  • What kinds of infections does clotrimazole actually treat?
  • You may start to notice some relief within a few days, but it's important to finish the full course. For athlete's foot and ringworm, that means using it every day for 4 weeks. For...
  • How long do I need to use it before it starts working?
📖 Read our full Clotrimazole 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 5TJD82A1ET
    A cooling crystalline substance made synthetically that is added to medicines as a fragrance, flavoring agent, and mild local irritant to produce a cooling or warming sensation on the skin or mucous membranes.
  • UNII S72O3284MS
    A plant extract from the gentian root used as a flavoring agent and bitter taste component in some medicines. It helps mask unpleasant tastes and may support digestive formulations.
  • 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • 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 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.

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

The official label also statesPurified Water, Camphor, Gentiana Lutea Root, Propylene Glycol, Glycerin, Methylparaben, Triethanolamine, Peppermint Oil

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Clotrimazole Antifungal Cream 1 g/100g 00536-1265-26 Rugby 1 tube $0.049 — Availability likely —
Clotrimazole 1 g/100g 70000-0667-01 Cardinal 1 tube $0.063 — Availability likely —
Clotrimazole 1% Athletes Foot 10 mg/g 70677-1002-01 STRATEGIC 1 tube $0.121 — Availability likely —
TM-Clotrimazole 1 g/100g 83035-1062-03 Singular 1 tube $0.121 — Availability likely —
Leader Athletes Foot Clotrimazole .01 g/g 70000-0542-01 LEADER 1 tube $0.122 — Discontinued —
clotrimazole 1 g/100g 45802-0434-01 Padagis 1 tube $0.146 — Discontinued —
Clotrimazole 1 g/100g 51672-2002-01 Sun 1 tube $0.185 — Availability likely —
Good Neighbor Pharmacy Clotrimazole 10 mg/g 24385-0205-01 AmerisourceBergen 1 tube $0.197 — Availability likely —
Antifungal Cream 1 g/100g 68001-0475-45 BluePoint 1 tube $0.197 — Availability likely —
Clotrimazole 10 mg/g 51672-1275-01 Sun 1 tube $0.198 AB Availability likely —
Clotrimazole 10 mg/g 68462-0181-17 Glenmark 15 g $0.198 AB Availability likely —
Rugby Antifungal Clotrimazole .01 g/g 00536-1272-11 Rugby 1 tube $0.228 — FDA listed —
Clotrimazole 10 mg/g 00168-0133-15 E. 15 g — AB FDA listed —
Clotrimazole 10 mg/g 00363-2105-01 Walgreen 1 tube — — FDA listed —
Ringworm 10 mg/g 00363-2107-01 Walgreen 1 tube — — FDA listed —
Walgreens Jock Itch 10 mg/g 00363-2109-01 Walgreen 1 tube — — FDA listed —
Lotrimin 10 mg/g 11523-0963-01 Bayer 1 tube — — FDA listed —
Lotrimin Antifungal 10 mg/g 11523-1125-01 Bayer 1 tube — — FDA listed —
Lotrimin 10 mg/g 11523-6549-01 Bayer 1 tube — — FDA listed —
Dr Sheffield Athletes Foot 10 mg/g 11527-0071-15 Sheffield 1 tube — — Discontinued —
Jock Itch 10 mg/g 11673-0062-15 TARGET 1 tube — — FDA listed —
Target Jock Itch 10 mg/g 11673-0893-14 Target 1 tube — — FDA listed —
UpandUp Clotrimazole 10 mg/g 11673-0910-02 Target 1 tube — — FDA listed —
Rite Aid antifungal ringworm 1 g/100g 11822-1110-01 Rite 1 tube — — FDA listed —
Clotrimazole Jock Itch 10 mg/g 11822-3423-01 Rite 1 tube — — FDA listed —
Signature Care Jock Itch 10 mg/g 21130-0210-01 Safeway 1 tube — — FDA listed —
Signature Care Athletes Foot 10 mg/g 21130-0870-14 Safeway 1 tube — — FDA listed —
Antifungal 10 mg/g 21922-0094-04 Encube 1 tube — — FDA listed —
terrasil Folliculitis Cream Maximum Strength 1 g/100g 24909-0064-50 Aidance 50 g — — FDA listed —
Kroger ATHLETES FOOT 10 mg/g 30142-0305-01 Kroger 1 tube — — FDA listed —
Kroger Jock Itch 10 mg/g 30142-0510-01 Kroger 1 tube — — FDA listed —
TopCare Antifungal 10 mg/g 36800-0495-69 Topco 1 tube — — FDA listed —
HEB Antifungal 10 mg/g 37808-0305-01 H 1 tube — — FDA listed —
meijer Athletes Foot 10 mg/g 41250-0305-02 Meijer 1 tube — — FDA listed —
Publix athletic foot 10 mg/g 41415-0056-75 Publix 1 tube — — FDA listed —
CAREONE Clotrimazole 10 mg/g 41520-0305-02 American 1 tube — — FDA listed —
Jock-Eze 10 mg/g 47832-0071-14 Bentlin 1 tube — — FDA listed —
Clotrimazole Athletes Foot 10 mg/g 49035-0812-01 Wal-Mart 1 tube — — FDA listed —
Jock Itch Clotrimazole Antifungal .01 g/g 49035-0837-05 WalMart 1 tube — — FDA listed —
clotrimazole 1 g/100g 50090-0562-00 A-S 1 tube — — FDA listed —
clotrimazole 1 g/100g 50090-1770-00 A-S 1 tube — — FDA listed —
Clotrimazole 1 g/100g 50090-4971-00 A-S 1 tube — — FDA listed —
Clotrimazole 1 g/100g 50090-6546-00 A-S 1 tube — — FDA listed —
Clotrimazole 10 mg/g 50090-7343-00 A-S 30 g — AB FDA listed —
Live Better Antifungal 10 mg/g 51143-0002-01 The 1 tube — — FDA listed —
CAREALL Clotrimazole 10 g/g 51824-0063-01 New 28 g — — FDA listed —
CAREALL Clotrimazole 10 mg/g 51824-0093-01 New 28 g — — FDA listed —
Fungicure Night Cream 10 mg/g 52389-0681-02 Kobayashi 1 tube — — FDA listed —
Clotrimazole 1% Athletes Foot 10 mg/g 52410-3024-04 Shield 28.3 g — — FDA listed —
Dermatin Antifungal .01 g/g 54473-0096-01 Melaleuca, 14 g — — FDA listed —
Fortinia 10 mg/g 54633-0314-80 The 80 g — — FDA listed —
Athletes Foot 10 mg/g 55315-0008-56 FRED'S, 1 tube — — FDA listed —
Family Wellness Clotrimazole 1 Anti Fungal Cream 10 mg/g 55319-0980-00 Family 1 tube — — FDA listed —
TheraPlus Plus 1 g/100g 55621-0003-01 Zhejiang 35 g — — FDA listed —
Cura Hongo Antifungal 1 g/100g 55758-0102-02 Pharmadel 1 tube — — Discontinued —
DG Health Athletes Foot 10 mg/g 55910-0118-00 Dolgencorp, 57 g — — FDA listed —
Publix Athletic Foot 10 mg/g 56062-0817-28 PUBLIX 1 tube — — FDA listed —
Micoclear 10 mg/g 57237-0350-15 Rising 1 tube — — FDA listed —
Mycozyl AC 10 mg/g 59088-0441-07 PureTek 85 g — — FDA listed —
Micotrin AC 10 mg/g 59088-0476-07 PureTek 85 g — — FDA listed —
Micomitin Antifungal 10 mg/g 59088-0642-07 PureTek 85 g — — FDA listed —
Clotrimazole 1% Athletes Foot 10 mg/g 59779-0305-01 CVS 1 tube — — FDA listed —
CVS Pharmacy ITCH RELIEF ANTIFUNGAL 10 mg/g 59779-0510-01 CVS 1 tube — — FDA listed —
CVS Antifungal Ringworm 1 g/100g 59779-0514-01 CVS 1 tube — — FDA listed —
Clotrimazole 1 g/100g 63187-0501-15 Proficient 1 tube — — FDA listed —
clotrimazole 1 g/100g 63187-0559-15 Proficient 1 tube — — FDA listed —
Antifungal 1% Clotrimazole Cream 1 g/100mL 64412-2010-01 Twincraft 1 tube — — FDA listed —
Family Care Antifungal 10 mg/g 65923-0052-28 United 1 tube — — FDA listed —
Major Clotrimazole 10 mg/g 66267-0980-15 NuCare 14.17 g — — FDA listed —
WinCo Foods Antifungal 10 mg/g 67091-0196-28 Winco 1 tube — — FDA listed —
Clotrimazole 10 mg/g 67296-2252-03 Redpharm 30 g — AB FDA listed —
Dynarex Antifungal 1 g/100g 67777-0231-11 Dynarex 6 tubes — — FDA listed —
Antifungal 1 g/100g 67777-0727-02 Dynarex 72 tubes — — FDA listed —
clotrimazole 1 g/100g 68071-3395-03 NuCare 30 g — — FDA listed —
clotrimazole 1 g/100g 68071-4225-05 NuCare 15 g — — FDA listed —
Clotrimazole 1% 10 mg/g 68747-3024-04 Dabur 28.3 g — — FDA listed —
Rugby Antifungal Clotrimazole .01 g/g 68788-8091-02 Preferred 1 tube — — FDA listed —
Clotrimazole 1 g/100g 68788-8216-03 Preferred 1 tube — — FDA listed —
Clotrimazole 1 g/100g 68788-8830-02 Preferred 1 tube — — FDA listed —
Rugby Clotrimazole Antifungal Cream 1 g/100g 68788-8901-02 Preferred 1 tube — — FDA listed —
PerfectHeal Antifungal 1 g/100g 69070-0303-01 Zhejiang 1 tube — — FDA listed —
Clotrimazole 1 g/100g 69396-0001-04 TRIFECTA 1 tube — — FDA listed —
Clotrimazole 1 g/100g 69396-0038-05 Trifecta 1 tube — — FDA listed —
Clotrimazole 1 g/100g 69396-0087-01 TRIFECTA 1 tube — — FDA listed —
FifthPulse clotrimazole cream 4oz 1 g/100g 69571-0019-01 Front 113.4 g — — FDA listed —
Clotrimazole 1% Athletes Foot 10 mg/g 69771-0032-23 GERI-GENTLE 113 g — — FDA listed —
Antifungal 1% Clotrimazole Cream 1 g/100mL 70856-3585-01 Defense 1 tube — — FDA listed —
Clotrimazole 10 mg/g 71205-0432-15 Proficient 1 tube — AB FDA listed —
Clotrimazole 1 g/100g 71205-0434-05 Proficient 1 tube — — FDA listed —
Rugby Antifungal Clotrimazole .01 g/g 71205-0738-15 Proficient 1 tube — — FDA listed —
Trimazole 1 g/100g 73352-0570-01 Trifluent 1 tube — — FDA listed —
Clotrimazole 1% Topical Antifungal Cream 1 g/100g 73715-0004-01 Mohnark 28 g — — Discontinued —
Clotrimazole 10 mg/g 80489-0002-01 OL 1 tube — — FDA listed —
Thera plus Antifungal Clotrimazole 10 mg/g 80684-0039-01 FOURSTAR 1 tube — — FDA listed —
Up and Up Athletes Foot 10 mg/g 82442-0022-28 Target 1 tube — — FDA listed —
SIMPLY VITAL Antifungal Cream 10 mg/mL 82460-0344-00 ALPHA 60 ml — — FDA listed —
SimplyVital Antifungal Clotrimazole 10 mg/mL 82460-0990-00 Alpha 1 jar — — FDA listed —
Clotrimazole 1% 1 g/100g 83324-0041-01 Chain 1 tube — — FDA listed —
PHARMBANNER Antifungal Soothing Cream 1 g/100g 83818-0017-01 Shenzhen 60 g — — FDA listed —
Megababe Fun Gal Stuff Antifungal 10 mg/g 84000-0908-00 Megababe 1 tube — — FDA listed —
Clotrimazole 10 mg/g 84387-0004-01 ALLIED 28.4 g — — FDA listed —
ElixirCurozole 1 g/100g 84546-0003-01 ELIXIR 1 tube — — FDA listed —
seebeellar clotrimazole 1% antifungal cream 1 g/100g 84558-0014-01 GUANGZHOU 100 g — — FDA listed —
Velloryn 1% Clotrimazole ANTIFUNGAL 1 g/100mL 84558-0017-01 GUANGZHOU 100 ml — — FDA listed —
Antifungal 1 g/100g 84722-3059-00 VIVE 1 g — — FDA listed —
DERMFREE Clotrimazole 1 g/100g 85248-0036-01 Jiangxi 60 g — — FDA listed —
SERYNTH Clotrimazole 1 g/100g 85248-0101-01 Jiangxi 30 g — — FDA listed —
Charmpoo TINEA VERSICOLOR TREATMENT ANTIFUNGAL 1 g/100g 85248-0143-01 Jiangxi 100 g — — FDA listed —
BODYKOO JOCK ITCH Cream 1 g/100g 85248-0228-01 Jiangxi 30 g — — FDA listed —
Tagrid Antifungal Ringworm Treatment 1% CLOTRIMAZOLE 1 g/100g 85384-0006-01 TAGRID 100 g — — FDA listed —
Tagrid Balanitis Relief 1 g/100g 85384-0018-01 TAGRID 30 g — — FDA listed —
Tagrid Antifungal Clotrimazole 1% 1 g/100g 85384-0019-01 TAGRID 100 g — — FDA listed —
Tagrid Antifungal Jock Itch Cream Non-Steroidal Clotrimazole 1% 1 g/100g 85384-0021-01 TAGRID 60 g — — FDA listed —
Tagrid Intertrigo Cream For Skin Fold Rash Clotrimazole 1% 1 g/100g 85384-0022-01 TAGRID 56.7 g — — FDA listed —
Tinea Versicolor Treatment Cream 10 mg/gthis 85398-0002-01 Beautivity 60 g — — FDA listed —
Hermon Clotrimazole antifungal treatment cream .57 g/57g 85398-0010-01 Beautivity 57 g — — FDA listed —
Terthon Clotrimazole 1% Antifungal Cream 1 g/100g 85849-0010-01 SOLALIA 30 g — — FDA listed —
Kerova ANTIFUNGAL 1 g/100g 85959-0002-01 Guangzhou 100 g — — FDA listed —
Kerova Clotrimazole 1 g/100g 85959-0003-01 Guangzhou 100 g — — FDA listed —
Clotrimazole 1% 10 mg/g 87228-1010-01 PHARMACY 28.4 g — — FDA listed —
Clotrimazole Cream 1 g/100g 87236-0014-14 Aldermed 1 tube — — FDA listed —
Athletes Foot Cream 1 g/100g 87739-0001-01 Shenzhen 28 g — — FDA listed —
Fungicure Liquid Gel 10 mg/g 52389-0733-09 Kobayashi 1 tube — — FDA listed —
Tagrid Antifungal Treament Clotrimazole 1% 10 mg/g 85384-0012-01 TAGRID 20 g — — FDA listed —
FifthPulse Clotrimazole Antifungal 10 mg/g 87525-0002-01 WeCare 1 tube — — FDA listed —
Tinea Versicolor Treatment Bar 10 mg/g 85398-0003-01 Beautivity 116 g — — FDA listed —
Alevazol 10 mg/g 29978-0918-60 Capital 1 tube — — FDA listed —
CAREALL Clotrimazole 10 mg/g 51824-0121-01 New 28 g — — FDA listed —
Clotrimazole 10 mg/g 73581-0451-01 YYBA 1 tube — — 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
May 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Clotrimazole (matched by generic name) — the program that covers self-administered drugs. 13 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Clotrimazole. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$6.43M
Claims incl. refills
276K
Beneficiaries
207.9K
Spend / beneficiary
$30.91
Spend / claim
$23.28
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Tinea Versicolor Treatment Cream (this brand).

Top reported reactions

Macular Degeneration812
Nausea811
Pain777
Headache735
Dyspnoea706
Fatigue641
Diarrhoea598

Age at onset

Neonate46
Infant16
Child33
Adolescent23
Adult1,078
Elderly891

Reporter sex

11,491 reports

Serious outcomes

Hospitalization3,956
Death925
Life-threatening676
Disabling394
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,006 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
85398-0002-01 You're viewing this 60 g in 1 TUBE (85398-002-01) 2025-05-12 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 ✓ 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 FDA registers it as 85398-002-01, 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: 85398-0002-01, written without dashes as 85398000201. 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 85398-0002-01, the first segment (85398) is the labeler code FDA assigned to Beautivity LLC; the middle segment (0002) 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 14 words ▾

Helps relieve & prevent itching, burning, cracking, and scaling associated with tinea nersicolor infections.

⏱️ Dosage and Administration 42 words ▾

Wash the affected area and dry thoroughly. Apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor, supervise children in the use of the product. If the condition persists longer, consult a doctor.

⚠️ Warnings 56 words ▾

For External Use Only it on children under 2 years of age unless directed by a doctor. avoid contact with eyes, if contact occurs, rinse the eyes very thoroughly with water. Stop Using and Ask a Physician if irritation occurs or there is no improvement within 4 weeks. keep out of the reach of young children.

📦 Storage and Handling 10 words ▾

Store at room temperature. Protect from excessive heat (above 104ºF/40ºC)

🧪 Active Ingredient 2 words ▾

Clotrimazole 1%

🧪 Inactive Ingredients 13 words ▾

Purified Water, Camphor, Gentiana Lutea Root, Propylene Glycol, Glycerin, Methylparaben, Triethanolamine, Peppermint Oil

🎯 Purpose 1 words ▾

Antifungal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85398-0001-01 · Beautivity 85398-0003-01 · 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.