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Fungicure Liquid Gel Clotrimazole 10 mg/g Gel — NDC 52389-733-09 (Billing 52389-0733-09)

by Kobayashi Healthcare International, Inc. · 1 TUBE, WITH APPLICATOR in 1 BOX / 9 g in 1 TUBE, WITH APPLICATOR

This is a package of Fungicure Liquid Gel Clotrimazole 10 mg/g Gel from Kobayashi Healthcare International, Inc., marketed since Dec 2015 and currently FDA-listed. It is this product's only package size.

NDC 52389-0733-09
🏷️ FDA NDC (as labeled) 52389-733-09 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

NDC database record

One package, one record: these facts belong to NDC 52389-733-09 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
52389 labeler · 733 product · 09 package
Package marketed since
Jan 4, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0072959015336
FDA record last changed
Jul 24, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 52389-733-09
Product NDC 52389-733
11-digit billing NDC 52389073309
RxCUI 1049535
UNII G07GZ97H65
UPC 0072959015336
Application # M005
SPL Set ID dfd03852-29bd-4e16-97f3-64dfde5f8ff8
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 2015-12-31
Route TOPICAL
Dosage form GEL
Substance CLOTRIMAZOLE
Quick answers
  • RxCUI (RxNorm): 1049535
Why two NDCs? The FDA registers this code as 52389-733-09 — 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 → 52389-0733-09. 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 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 treats fungal and yeast infections. Skin products treat athlete's foot, jock itch and ringworm. Vaginal creams treat vaginal yeast infections, and CLOTIC ear solution treats fun...
  • Wash and dry the area, then apply a thin layer twice a day, morning and night. Most labels say about 4 weeks for athlete's foot and ringworm and 2 weeks for jock itch. See a doctor...
  • The skin products listed here say they are not effective on the scalp or nails. If the infection is there, check with your doctor.
  • With CLOTIC ear solution, the reported ones were headache, pain where it goes in, ringing in the ear and tingling. Vaginal cream can briefly increase burning or itching. Call your...
📖 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.

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
52389-0733-09 You're viewing this Main listing 1 TUBE, WITH APPLICATOR in 1 BOX / 9 g in 1 TUBE, WITH APPLICATOR 2016-01-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clotrimazole 1% Athletes Foot 10 mg/g 70677-1002-01 STRATEGIC 1 tube $0.118 — Availability likely —
Good Neighbor Pharmacy Clotrimazole 10 mg/g 24385-0205-01 AmerisourceBergen 1 tube $0.197 — Availability likely —
Clotrimazole 10 mg/g 68462-0181-17 Glenmark 15 g $0.199 AB Availability likely —
Clotrimazole 10 mg/g 51672-1275-01 Sun 1 tube $0.199 AB Availability likely —
Fungicure Liquid Gel 10 mg/gthis 52389-0733-09 Kobayashi 1 tube — — FDA listed —
Forticept Antifungal Foot Gel .01 kg/kg 72127-0806-00 Lidan, 085 kg — — FDA listed —
Jock-Eze 10 mg/g 47832-0071-14 Bentlin 1 tube — — FDA listed —
Clotrimazole 10 mg/g 71205-0432-15 Proficient 1 tube — AB FDA listed —
Thera plus Antifungal Clotrimazole 10 mg/g 80684-0039-01 FOURSTAR 1 tube — — FDA listed —
Lotrimin 10 mg/g 11523-6549-01 Bayer 1 tube — — FDA listed —
Clotrimazole Athletes Foot 10 mg/g 49035-0812-01 Wal-Mart 1 tube — — FDA listed —
Clotrimazole 10 mg/g 50090-7343-00 A-S 30 g — AB FDA listed —
Micomitin Antifungal 10 mg/g 59088-0642-07 PureTek 85 g — — FDA listed —
CVS Pharmacy ITCH RELIEF ANTIFUNGAL 10 mg/g 59779-0510-01 CVS 1 tube — — FDA listed —
Lotrimin Antifungal 10 mg/g 11523-1125-01 Bayer 1 tube — — FDA listed —
Clotrimazole 1% Athletes Foot 10 mg/g 69771-0032-23 GERI-GENTLE 113 g — — FDA listed —
Signature Care Athletes Foot 10 mg/g 21130-0870-14 Safeway 1 tube — — FDA listed —
HEB Antifungal 10 mg/g 37808-0305-01 H 1 tube — — FDA listed —
Clotrimazole 1% Athletes Foot 10 mg/g 52410-3024-04 Shield 28.3 g — — FDA listed —
Fortinia 10 mg/g 54633-0314-80 The 80 g — — FDA listed —
Clotrimazole 1% Athletes Foot 10 mg/g 59779-0305-01 CVS 1 tube — — FDA listed —
Clotrimazole Jock Itch 10 mg/g 11822-3423-01 Rite 1 tube — — FDA listed —
CAREONE Clotrimazole 10 mg/g 41520-0305-02 American 1 tube — — FDA listed —
Clotrimazole 10 mg/g 00168-0133-15 E. 15 g — AB FDA listed —
Major Clotrimazole 10 mg/g 66267-0980-15 NuCare 14.17 g — — FDA listed —
Walgreens Jock Itch 10 mg/g 00363-2109-01 Walgreen 1 tube — — FDA listed —
Clotrimazole 10 mg/g 84387-0004-01 ALLIED 28.4 g — — FDA listed —
Clotrimazole 1% 10 mg/g 87228-1010-01 PHARMACY 28.4 g — — FDA listed —
Lotrimin 10 mg/g 11523-0963-01 Bayer 1 tube — — FDA listed —
Jock Itch 10 mg/g 11673-0062-15 TARGET 1 tube — — FDA listed —
Antifungal 10 mg/g 21922-0094-04 Encube 1 tube — — FDA listed —
Kroger ATHLETES FOOT 10 mg/g 30142-0305-01 Kroger 1 tube — — FDA listed —
CAREALL Clotrimazole 10 mg/g 51824-0093-01 New 28 g — — FDA listed —
Micotrin AC 10 mg/g 59088-0476-07 PureTek 85 g — — FDA listed —
WinCo Foods Antifungal 10 mg/g 67091-0196-28 Winco 1 tube — — FDA listed —
Ringworm 10 mg/g 00363-2107-01 Walgreen 1 tube — — FDA listed —
Signature Care Jock Itch 10 mg/g 21130-0210-01 Safeway 1 tube — — FDA listed —
Fungicure Night Cream 10 mg/g 52389-0681-02 Kobayashi 1 tube — — FDA listed —
Family Wellness Clotrimazole 1 Anti Fungal Cream 10 mg/g 55319-0980-00 Family 1 tube — — FDA listed —
Megababe Fun Gal Stuff Antifungal 10 mg/g 84000-0908-00 Megababe 1 tube — — FDA listed —
Family Care Antifungal 10 mg/g 65923-0052-28 United 1 tube — — FDA listed —
Clotrimazole 10 mg/g 67296-2252-03 Redpharm 30 g — AB FDA listed —
Clotrimazole 10 mg/g 00363-2105-01 Walgreen 1 tube — — FDA listed —
Tinea Versicolor Treatment Cream 10 mg/g 85398-0002-01 Beautivity 60 g — — FDA listed —
TopCare Antifungal 10 mg/g 36800-0495-69 Topco 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 —
Publix athletic foot 10 mg/g 41415-0056-75 Publix 1 tube — — FDA listed —
Live Better Antifungal 10 mg/g 51143-0002-01 The 1 tube — — FDA listed —
DG Health Athletes Foot 10 mg/g 55910-0118-00 Dolgencorp, 57 g — — FDA listed —
Mycozyl AC 10 mg/g 59088-0441-07 PureTek 85 g — — FDA listed —
Tinea Versicolor Treatment Bar 10 mg/g 85398-0003-01 Beautivity 116 g — — FDA listed —
Dr Sheffield Athletes Foot 10 mg/g 11527-0071-15 Sheffield 1 tube — — Discontinued —
UpandUp Clotrimazole 10 mg/g 11673-0910-02 Target 1 tube — — FDA listed —
Alevazol 10 mg/g 29978-0918-60 Capital 1 tube — — FDA listed —
Kroger Jock Itch 10 mg/g 30142-0510-01 Kroger 1 tube — — FDA listed —
meijer Athletes Foot 10 mg/g 41250-0305-02 Meijer 1 tube — — FDA listed —
Athletes Foot 10 mg/g 55315-0008-56 FRED'S, 1 tube — — FDA listed —
Clotrimazole 1% 10 mg/g 68747-3024-04 Dabur 28.3 g — — 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

🏛️
2015
On the market since
Dec 2015
📍
2026
Currently FDA-listed
11 years 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerKobayashi Healthcare International, Inc.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code52389
First marketedDec 2015
Product typeHuman Otc Drug
Portfolio26 products on file

More NDCs from Kobayashi Healthcare International, Inc. labeler code 52389

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 💬 Information for Patients
🎯 Indications and Usage 29 words ▾

Uses For the cure of most ringworm (tinea corporis) athlete's foot (tinea pedis) For relief of itching scaling cracking burning redness soreness irritation discomforts which may accompany these conditions.

⏱️ Dosage and Administration 142 words ▾

Directions Read all package directions and warnings before use. Use only as directed. Clean the affected area with soap and warm water and dry thoroughly.

Apply a thin layer of Fungicure over the affected area twice daily (morning and night), or as directed by a doctor. This product is not effective on scalp or nails. Avoid applying to severely cracked or irritated areas.

For ringworm and athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor. For athlete's foot, pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor. Supervise children in the use of this product.

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 5 words ▾

Active Ingredient Clotrimazole 1% w/w

🧪 Inactive Ingredients 6 words ▾

Inactive ingredients Hydroxypropylcellulose and isopropyl alcohol.

🎯 Purpose 2 words ▾

Purpose Antifungal

💬 Information for Patients 84 words ▾

Other information Fungicure may be applied to exposed nail-beds, cuticles, around nail edges and under nail tips where reachable with its applicator brush. This product is not intended to, nor will it, penetrate hard nail surfaces. While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use Fungicure until satisfactory results are obtained.

You may report serious side effects to the phone number provided under Questions? below.

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

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 Fungicure Liquid Gel (this brand).

Top reported reactions

Macular Degeneration812
Nausea811
Pain777
Headache735
Dyspnoea705
Fatigue640
Diarrhoea598

Age at onset

Neonate46
Infant16
Child33
Adolescent23
Adult1,078
Elderly891

Reporter sex

11,490 reports
Male · 34%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization3,953
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 993 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) — 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 Kobayashi Healthcare International, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Kobayashi Healthcare International, Inc. 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.
← 52389-0681-02 · Kobayashi 52389-0752-02 · Kobayashi →
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.