Clotrimazole (Topical Solution), 1% 10 mg/mL Solution
by Puro Pharma Inc. · 1 BOTTLE, DROPPER in 1 CARTON (83474-003-34) / 10 mL in 1 BOTTLE, DROPPER
NDC 83474-0003-34
🏷️ FDA NDC (as labeled)
83474-003-34
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)
83474-003-34
Product NDC
83474-003
11-digit billing NDC
83474000334
NCPDP billing unit
ML — per mL (volume)
RxCUI
309370
UNII
G07GZ97H65
UPC
0383474003341
Application #
M005
SPL Set ID
cb424fa8-3ed5-45cd-b03f-64675584b34e
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
2024-04-15
Route
TOPICAL
Dosage form
SOLUTION
Substance
CLOTRIMAZOLE
GPI-14
90154020002005
GCN Seq No
007362
GCN
30380
HICL code
004137
Ingredient (HICL)
Clotrimazole
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q5
Therapeutic class — intermediate (HIC2)
Agents Acting Principally On The Skin
HIC3 code
Q5F
Therapeutic class — specific (HIC3)
Topical Antifungals
AHFS code
84:04.08.08
AHFS class
Azoles (Skin And Mucous Membrane)
FDB label name
CLOTRIMAZOLE 1% SOLUTION
FDB brand name
Clotrimazole
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 83474-003-34 — 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 → 83474-0003-34. 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
LabelerPuro Pharma Inc.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code83474
First marketedApr 2024
Product typeHuman Otc Drug
Portfolio3 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
Label name CLOTRIMAZOLE 1% SOLUTION Ingredient Clotrimazole
📖 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?
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 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
1 inactive ingredient listed in the exact product block matched to this NDC.
The official label also statespolyethylene glycol
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 | $2.018 | $20.18 / 10 ml |
| Medicaid paysCMS SDUD · 12 mo | $2.00 | $19.95 / 10 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per mL) — tap or hover for the price & month
▼ Down 14% over the last 10 months.
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 | $0.426 | AT | Availability likely | save 79% |
| Clotrimazole Topical Solution USP, 1% 10 mg/mL 52817-0800-30 | TruPharma | 1 bottle | $0.426 | AT | Availability likely | save 79% |
| Clotrimazole 10 mg/mL 70954-0036-20 | Novitium | 1 bottle | $0.426 | AT | Availability likely | save 79% |
| Clotrimazole 1 g/100mL 00536-1443-70 | Rugby | 1 bottle | $2.018 | — | Availability likely | — |
| Clotrimazole 1 g/mL 51672-2158-01 | Sun | 1 bottle | $2.018 | — | Availability likely | — |
| Clotrimazole 1 g/mL 70010-0229-54 | Granules | 10 ml | $2.018 | — | Availability likely | — |
| Clotrimazole (Topical Solution), 1% 10 mg/mLthis 83474-0003-34 | Puro | 1 bottle | $2.018 | — | Availability likely | — |
| Clotrimazole 1 g/mL 00536-1181-70 | RUGBY | 10 ml | $2.371 | — | FDA listed | +17% |
| Clotrimazole Topical Solution USP, 1% 10 mg/mL 50228-0502-08 | ScieGen | 1 bottle | $2.742 | AT | Availability likely | +36% |
| Clotrimazole 1 g/mL 10135-0671-81 | Marlex | 1 bottle | — | — | 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/L 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 | — |
| Clotrimazole 10 mg/mL 68788-4155-03 | Preferred | 1 bottle | — | AT | 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
🏛️
2024
On the market since
Apr 2024
📍
2026
Currently FDA-listed
2 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.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 83474-0003-34, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
227
Units reimbursed last 4 qtrs
3.5K
Gross reimbursed last 4 qtrs
$6.9K
Avg / prescription
$30.50
Avg / unit
$1.9954
Latest quarter Q4 2025
14Rx
Medicaid pays / mL
$1.9954
gross reimbursed
vs
NADAC / mL
$2.0179
acquisition cost
=
Spread
−$0.0225
-1% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 227 Rx Managed care · 0 Rx
State Medicaid map
Units reimbursed · per 100k residents
3.910.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
📊 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 — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
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 |
|---|---|---|---|
| 83474-0003-34 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (83474-003-34) / 10 mL in 1 BOTTLE, DROPPER | 2024-04-15 | Active |
📄 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) • Ringworm (tinea corporis) Effectively relieves • itching • cracking • burning • discomfort which can accompany these conditions.
⏱️ Dosage and Administration ▾
Directions • This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks.
For jock itch: use daily for 2 weeks. • clean the affected area and dry thoroughly • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor • supervise children in the use of this product. For athlete's foot: pay special attention to spaces between the toes: wear well-fitting, ventilated shoes; change shoes and socks at least once daily.
⚠️ Warnings ▾
Warnings For external use only. Ask a doctor before use • on children under 2 years of age When using this product • avoid contact with eyes Stop use and ask a doctor if • irritation occurs • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch) Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information • store between 15°-30°C (59°-86°F)
🧪 Active Ingredient ▾
Active ingredient Clotrimazole USP, 1%
🧪 Inactive Ingredients ▾
Inactive ingredient polyethylene glycol
🎯 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.