Clotrimazole Antifungal 10 g/L Solution, 1 bottle
by Trifecta Pharmaceuticals USA, LLC. · 1 BOTTLE in 1 BOX (69396-143-33) / .01 L in 1 BOTTLE
NDC 69396-0143-33
🏷️ FDA NDC (as labeled)
69396-143-33
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 →
⚠️
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)
69396-143-33
Product NDC
69396-143
11-digit billing NDC
69396014333
RxCUI
309370
UNII
G07GZ97H65
UPC
0850058161006
Application #
M005
SPL Set ID
11bf50db-552e-0a39-e063-6394a90af60d
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
2023-11-13
Route
TOPICAL
Dosage form
SOLUTION
Substance
CLOTRIMAZOLE
Why two NDCs?
The FDA registers this code as 69396-143-33 — 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 → 69396-0143-33. 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
LabelerTrifecta Pharmaceuticals USA, LLC.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code69396
First marketedNov 2023
Product typeHuman Otc Drug
Portfolio16 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
📗 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Clotrimazole — tap one for details:
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.
💬 Questions about Clotrimazole?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
-
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 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.
3 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesEthanol, Propylene glycol, purified water
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 system | Per mL | Per 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clotrimazole 10 mg/mL 51672-1260-03 | Sun | 1 bottle | $0.442 | AT | Availability likely | — |
| Clotrimazole Topical Solution USP, 1% 10 mg/mL 52817-0800-30 | TruPharma | 1 bottle | $0.442 | AT | Availability likely | — |
| Clotrimazole 10 mg/mL 70954-0036-20 | Novitium | 1 bottle | $0.442 | AT | Availability likely | — |
| Clotrimazole 1 g/mL 00536-1181-70 | RUGBY | 10 ml | $2.371 | — | FDA listed | — |
| Clotrimazole 1 g/100mL 00536-1443-70 | Rugby | 1 bottle | $2.376 | — | Availability likely | — |
| Clotrimazole 1 g/mL 51672-2158-01 | Sun | 1 bottle | $2.376 | — | Availability likely | — |
| Clotrimazole 1 g/mL 70010-0229-54 | Granules | 10 ml | $2.376 | — | Availability likely | — |
| Clotrimazole (Topical Solution), 1% 10 mg/mL 83474-0003-34 | Puro | 1 bottle | $2.376 | — | Availability likely | — |
| Clotrimazole 1 g/mL 10135-0671-81 | Marlex | 1 bottle | — | — | FDA listed | — |
| Clotrimazole Topical Solution USP, 1% 10 mg/mL 50228-0502-08 | ScieGen | 1 bottle | — | AT | FDA listed | — |
| Clotrimazole 1 g/mL 50268-0044-30 | AvPAK | 1 bottle | — | — | FDA listed | — |
| Fungicure Intensive 10 mg/mL 52389-0600-60 | Kobayashi | 1 bottle | — | — | FDA listed | — |
| Fortinia OF 1 g/100mL 54633-0017-01 | The | 29.57 ml | — | — | FDA listed | — |
| Clotrimazole 1 g/mL 54633-0018-10 | The | 1 bottle | — | — | FDA listed | — |
| Fortinia Ultra 1 g/100mL 54633-0025-15 | The | 15 ml | — | — | FDA listed | — |
| Fortinia 1 g/100mL 54633-0214-01 | The | 29.57 ml | — | — | FDA listed | — |
| Lasolex Liquid Solution 10 mg/mL 59088-0251-03 | PureTek | 30 ml | — | — | FDA listed | — |
| Clotrimazole 1 g/mL 68788-4080-01 | Preferred | 10 ml | — | — | FDA listed | — |
| Clotrimazole Antifungal 10 g/Lthis 69396-0143-33 | Trifecta | 1 bottle | — | — | FDA listed | — |
| Akin Anti-Fungal 10 mg/mL 69822-0254-05 | Southern | 1 bottle | — | — | FDA listed | — |
| Smooth Gator Fungus Eliminator 10 mg/mL 70673-0747-01 | Smooth | 59 ml | — | — | FDA listed | — |
| Clotrimazole 1 g/mL 70795-8020-01 | GRAXCELL | 10 ml | — | — | FDA listed | — |
| Clotrimazole Topical Solution USP, 1% 10 mg/mL 71297-0030-02 | Allegis | 2 bottles | — | AT | FDA listed | — |
| Clotrimazole 1 g/mL 71399-0500-01 | Akron | 10 ml | — | — | FDA listed | — |
| Clotrimazole Topical Solution USP, 1% 10 mg/mL 71399-0666-03 | Akron | 1 bottle | — | AT | FDA listed | — |
| Clotrimazole Topical Solution USP, 1% 10 mg/mL 72162-2178-03 | Bryant | 1 bottle | — | AT | FDA listed | — |
| WELMATE Clotrimazole Topical Solution 10 mg/mL 73581-0449-00 | YYBA | 1 bottle | — | — | FDA listed | — |
| Terramed Just Think Comfort Clotrimazole Antifungal Topical Solution 10 mg/mL 83004-0042-01 | Rida | 3 bottles | — | — | 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
🏛️
2023
On the market since
Nov 2023
📍
2026
Currently FDA-listed
3 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.
📊 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 Clotrimazole Antifungal (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 34%
Female · 65%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69396-0143-33 You're viewing this | 1 BOTTLE in 1 BOX (69396-143-33) / .01 L in 1 BOTTLE | 2023-11-13 | 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 | — 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 FDA registers it as 69396-143-33, 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: 69396-0143-33, written without dashes as 69396014333. 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 69396-0143-33, the first segment (69396) is the labeler code FDA assigned to Trifecta Pharmaceuticals USA, LLC.; the middle segment (0143) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (33) 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 Trifecta Pharmaceuticals USA, LLC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Trifecta Pharmaceuticals USA, 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 ▾
Uses Cures most Athlete's foot (tinea pedis) Jock Itch (Tinea Cruris) Ringwork (Tinea corporis) Effectively relieves Itching Cracking Burning Discomfort that can accompany these conditions
⏱️ Dosage and Administration ▾
Directions Spray over affected area If bandaged, let dry first Not to be used on children under 12 years of age
⚠️ Warnings ▾
Warnings For External Use Only
📦 Storage and Handling ▾
Other information Store at controlled room temperature 15º-30ºC (59º-86ºF)
🧪 Active Ingredient ▾
Active Ingredient Clotrimazole USP, 1.0%
🧪 Inactive Ingredients ▾
Inactive Ingredients Ethanol, Propylene glycol, purified water
🎯 Purpose ▾
Purpose Antifungal
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.