Clotrimazole Topical Solution USP, 1% 10 mg/mL Solution — NDC 52817-800-30 (Billing 52817-0800-30)
This is a package of Clotrimazole Topical Solution USP, 1% 10 mg/mL Solution from TruPharma LLC, marketed since Jul 2019 and currently FDA-listed; retail pharmacies pay about $0.4257 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 52817-800-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 52817 labeler · 800 product · 30 package
- Package marketed since
- Jul 25, 2019
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0352817800305
- Medicaid fills, this package
- 37,360 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 007362
- GCN: 30380
- GPI-14 (Medi-Span): 90154020002005
- HICL (First Databank): 004137
- AHFS class code: 84:04.08.08
- RxCUI (RxNorm): 309370
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Azole Antifungal class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 8, 2026
Clinical
- 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...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.426 | $12.77 / 30 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.9273 | $27.82 / 30 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.6637 | $19.91 / 30 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 52817-0800-30 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE | 2019-07-25 | — | Active |
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 | — |
| Clotrimazole Topical Solution USP, 1% 10 mg/mLthis 52817-0800-30 | TruPharma | 1 bottle | $0.426 | AT | Availability likely | — |
| Clotrimazole 10 mg/mL 70954-0036-20 | Novitium | 1 bottle | $0.426 | AT | Availability likely | — |
| Clotrimazole 1 g/100mL 00536-1443-70 | Rugby | 1 bottle | $2.018 | — | Availability likely | +374% |
| Clotrimazole 1 g/mL 51672-2158-01 | Sun | 1 bottle | $2.018 | — | Availability likely | +374% |
| Clotrimazole 1 g/mL 70010-0229-54 | Granules | 10 ml | $2.018 | — | Availability likely | +374% |
| Clotrimazole (Topical Solution), 1% 10 mg/mL 83474-0003-34 | Puro | 1 bottle | $2.018 | — | Availability likely | +374% |
| Clotrimazole 1 g/mL 00536-1181-70 | RUGBY | 10 ml | $2.371 | — | FDA listed | +457% |
| Clotrimazole Topical Solution USP, 1% 10 mg/mL 50228-0502-08 | ScieGen | 1 bottle | $2.742 | AT | Availability likely | +544% |
| 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Clotrimazole inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
1 inactive ingredient listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from TruPharma LLC labeler code 52817
- Clonidine Transdermal System USP, 0.1 mg/day .1 mg/d Patch NDC 52817-610-04
- Clonidine Transdermal System USP, 0.2 mg/day .2 mg/d Patch NDC 52817-611-04
- Clonidine Transdermal System USP, 0.3 mg/day .3 mg/d Patch NDC 52817-612-04
- Tramadol Hydrochloride 5 mg/mL Solution NDC 52817-615-16
- Baclofen 10 mg/5mL Solution NDC 52817-620-08
- apomorphine hydrocloride APOMORPHINE HYDROCHLORIDE 30 mg/3mL Injection NDC 52817-720-05
- Triamcinolone Acetonide 1 mg/g Cream NDC 52817-811-15
- Aminocaproic acid .25 g/mL Solution NDC 52817-815-08
- Acetic Acid 20.65 mg/mL Solution NDC 52817-816-15
- hydrocortisone acetate pramoxine HCl 2.5 g/100g; 1 g/100g Cream NDC 52817-817-01
- Metformin Hydrochloride Oral Solution 500 mg/5mL Solution NDC 52817-820-50
- Metformin Hydrochloride Oral Solution 500 mg/5mL Solution NDC 52817-821-50
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Prescription clotrimazole topical solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton fluoccosum , and Microsporum canis .
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Gently massage sufficient clotrimazole topical solution USP, 1% into the affected and surrounding skin areas twice a day, in the morning and evening. Clinical improvement, with relief of pruritus, usually occurs within the first week of treatment with clotrimazole topical solution USP, 1%. If the patient shows no clinical improvement after 4 weeks of treatment with clotrimazole topical solution USP, 1%, the diagnosis should be reviewed.
⛔ Contraindications ▾
CONTRAINDICATIONS Topical antifungal agents are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
⚠️ Warnings ▾
WARNINGS Clotrimazole topical solution is not for ophthalmic use.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been reported in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritius, urticaria, burning, and general irritation of the skin.
🔄 Drug Interactions ▾
Drug Interactions Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.
🤰 Pregnancy ▾
Usage in Pregnancy The disposition of 14 C-clotrimazole has been studied in humans and animals. Clotrimazole is very poorly absorbed following dermal application or intravaginal administration to humans. (See CLINICAL PHARMACOLOGY .) In clinical trials, use of vaginally applied clotrimazole in pregnant women in their second and third trimesters has not been associated with ill effects.
There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Studies in pregnant rats with intravaginal doses up to 100 mg/kg have revealed no evidence of harm to the fetus due to clotrimazole. High oral doses of clotrimazole in rats and mice ranging from 50 to 120 mg/kg resulted in embryotoxicity (possibly secondary to maternal toxicity), impairment of mating, decreased litter size and number of viable young and decreased pup survival to weaning.
However, clotrimazole was not teratogenic in mice, rabbits and rats at oral doses up to 200, 180 and 100 mg/kg, respectively. Oral absorption in the rat amounts to approximately 90% of the administered dose. Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly indicated during the first trimester of pregnancy.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have been established for clotrimazole when used as indicated and in the recommended dosage.
🆘 Overdosage ▾
OVERDOSAGE Acute overdosage with topical application of clotrimazole is unlikely and would not be expected to lead to a life-threatening situation.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Clotrimazole is a broad-spectrum antifungal agent that is used for the treatment of dermal infections caused by various species of pathogenic dermatophytes, yeasts, and Malassezia furfur . The primary action of clotrimazole is against dividing and growing organisms. In vitro , clotrimazole exhibits fungistatic and fungicidal activity against isolates of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis , and Candida species including Candida albicans .
In general, the in vitro activity of clotrimazole corresponds to that of tolnaftate and griseofulvin against the mycelia of dermatophytes ( Trichophyton, Microsporum , and Epidermophyton ), and to that of the polyenes (amphotericin B and nystatin) against budding fungi ( Candida ). Using an in vivo (mouse) and an in vitro (mouse kidney homogenate) testing system, clotrimazole and miconazole were equally effective in preventing the growth of the pseudomycelia and mycelia of Candida albicans . Strains of fungi having a natural resistance to clotrimazole are rare.
Only a single isolate of Candida guilliermondi has been reported to have primary resistance to clotrimazole. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Candida albicans and Trichophyton mentagrophytes . No appreciable change in sensitivity was detected after successive passages of isolates of C. albicans, C. krusei , or C. pseudotropicalis in liquid or solid media containing clotrimazole.
Also, resistance could not be developed in chemically induced mutant strains of polyene-resistant isolates of C. albicans . Slight, reversible resistance was noted in three isolates of C. albicans tested by one investigator. There is a single report that records the clinical emergence of a C. albicans strain with considerable resistance to flucytosine and miconazole, and with cross-resistance to clotrimazole; the strain remained sensitive to nystatin and amphotericin B.
In studies of the mechanism of action, the minimum fungicidal concentration of clotrimazole caused leakage of intracellular phosphorus compounds into the ambient medium with concomitant breakdown of cellular nucleic acids and accelerated potassium efflux. Both these events began rapidly and extensively after addition of the drug. Clotrimazole appears to be well absorbed in humans following oral administration and is eliminated mainly as inactive metabolites.
Following topical and vaginal administration, however, clotrimazole appears to be minimally absorbed. Six hours after the application of radioactive clotrimazole 1% cream and 1% solution onto intact and acutely inflamed skin, the concentration of clotrimazole varied from 100 mcg/cm 3 , in the stratum corneum to 0.5 to 1 mcg/cm 3 in the stratum reticulare, and 0.1 mcg/cm 3 in the subcutis. No measurable amount of radioactivity (≤0.001 mcg/mL) was found in the serum within 48 hours after application under occlusive dressing of 0.5 mL of the solution or 0.8 g of the cream.
Only 0.5% or less of the applied radioactivity was excreted in the urine. Following intravaginal administration of 100 mg 14 C-clotrimazole vaginal tablets to nine adult females, an average peak serum level, corresponding to only 0.03 µg equivalents/mL of clotrimazole, was reached 1 to 2 days after application. After intravaginal administration of 5 g of 1% 14 C-clotrimazole vaginal cream containing 50 mg active drug, to five subjects (one with candidal colpitis), serum levels corresponding to approximately 0.01 µg equivalents/mL were reached between 8 and 24 hours after application.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Clotrimazole topical solution USP, 1% is supplied in 30 mL plastic bottles (NDC 52817-800-30); boxes of one. Store between 2° to 30°C (36° to 86°F).
📦 Storage and Handling ▾
Store between 2° to 30°C (36° to 86°F).
📋 Description ▾
DESCRIPTION Clotrimazole topical solution USP, 1% contains 10 mg clotrimazole USP, a synthetic antifungal agent having the chemical name 1-(o-Chloro-α,α-diphenylbenzyl) imidazole with the following strctural formula: MOLECULAR FORMULA C 22 H 17 CIN 2 MOLECULAR WEIGHT 344.85 Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol, and chloroform. Each mL of clotrimazole topical solution USP, 1% contains 10 mg clotrimazole USP in a nonaqueous vehicle of polyethylene glycol 400. clotrimazole-01.jpg
💬 Information for Patients ▾
Information for Patients This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. The patient should be advised to: Use the medication for the full treatment time even though the symptoms may have improved.
Notify the physician if there is no improvement after 4 weeks of treatment. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization. Avoid sources of infection or reinfection.
⚠️ Precautions ▾
PRECAUTIONS General If irritation or sensitivity develops with the use of clotrimazole, treatment should be discontinued and appropriate therapy instituted. Information for Patients This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.
The patient should be advised to: Use the medication for the full treatment time even though the symptoms may have improved. Notify the physician if there is no improvement after 4 weeks of treatment. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization.
Avoid sources of infection or reinfection. Laboratory Tests If there is lack of response to clotrimazole, appropriate microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens before instituting another course of antimycotic therapy. Drug Interactions Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.
Carcinogenesis, Mutagenesis, and Impairment of Fertility An 18-month oral dosing study with clotrimazole in rats has not revealed any carcinogenic effect. In tests for mutagenesis, chromosomes of the spermatophores of Chinese hamsters which had been exposed to clotrimazole were examined for structural changes during the metaphase. Prior to testing, the hamsters had received five oral clotrimazole doses of 100 mg/kg body weight.
The results of this study showed that clotrimazole had no mutagenic effect. Usage in Pregnancy The disposition of 14 C-clotrimazole has been studied in humans and animals. Clotrimazole is very poorly absorbed following dermal application or intravaginal administration to humans.
(See CLINICAL PHARMACOLOGY .) In clinical trials, use of vaginally applied clotrimazole in pregnant women in their second and third trimesters has not been associated with ill effects. There are, however, no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Studies in pregnant rats with intravaginal doses up to 100 mg/kg have revealed no evidence of harm to the fetus due to clotrimazole.
High oral doses of clotrimazole in rats and mice ranging from 50 to 120 mg/kg resulted in embryotoxicity (possibly secondary to maternal toxicity), impairment of mating, decreased litter size and number of viable young and decreased pup survival to weaning. However, clotrimazole was not teratogenic in mice, rabbits and rats at oral doses up to 200, 180 and 100 mg/kg, respectively. Oral absorption in the rat amounts to approximately 90% of the administered dose.
Because animal reproduction studies are not always predictive of human response, this drug should be used only if clearly indicated during the first trimester of pregnancy. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when clotrimazole is used by a nursing woman.
Pediatric Use Safety and effectiveness in pediatric patients have been established for clotrimazole when used as indicated and in the recommended dosage.
🍼 Nursing Mothers ▾
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when clotrimazole is used by a nursing woman.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, and Impairment of Fertility An 18-month oral dosing study with clotrimazole in rats has not revealed any carcinogenic effect. In tests for mutagenesis, chromosomes of the spermatophores of Chinese hamsters which had been exposed to clotrimazole were examined for structural changes during the metaphase. Prior to testing, the hamsters had received five oral clotrimazole doses of 100 mg/kg body weight.
The results of this study showed that clotrimazole had no mutagenic effect.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton NDC 52817-800-30 Clotrimazole Topical Solution USP, 1% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. Rx only 30 mL Carton label