{"id":"sulconazole","rwe":[],"_fda":{"id":"f03361cb-005c-4d0c-bc27-033484f02624","set_id":"1d822e06-f37e-4984-8365-efd4c4451478","openfda":{"unii":["1T89100D5U"],"route":["TOPICAL"],"rxcui":["106366","208117"],"spl_id":["f03361cb-005c-4d0c-bc27-033484f02624"],"brand_name":["Exelderm"],"spl_set_id":["1d822e06-f37e-4984-8365-efd4c4451478"],"package_ndc":["69489-711-60"],"product_ndc":["69489-711"],"generic_name":["SULCONAZOLE NITRATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["SULCONAZOLE NITRATE"],"manufacturer_name":["Journey Medical Corporation"],"application_number":["NDA018737"],"is_original_packager":[true]},"version":"2","pregnancy":["Pregnancy There are no adequate and well-controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if clearly needed. Sulconazole nitrate has been shown to be embryotoxic in rats when given in doses of 125 times the adult human dose (in mg/kg). The drug was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day. Sulconazole nitrate given orally to rats at a dose 125 times the human dose resulted in prolonged gestation and dystocia. Several females died during the prenatal period, most likely due to labor complications."],"description":["DESCRIPTION EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in EXELDERM CREAM, is an imidazole derivative with in vitro antifungal and antiyeast activity. Its chemical name is (±)-1-[2,4-dichloro- β -[( p -chlorobenzyl)-thiol]-phenethyl]imidazole mononitrate and it has the following chemical structure: Sulconazole nitrate, USP is a white to off-white crystalline powder with a molecular weight of 460.77. It is freely soluble in pyridine; slightly soluble in ethanol, acetone, and chloroform; and very slightly soluble in water. It has a melting point of about 130°C. EXELDERM CREAM contains sulconazole nitrate, USP 10 mg/g in an emollient cream base consisting of propylene glycol, stearyl alcohol, isopropyl myristate, cetyl alcohol, polysorbate 60, sorbitan mono-stearate, glyceryl stearate (and) PEG-100 stearate, ascorbyl paImitate, and purified water, with sodium hydroxide and/or nitric acid added to adjust the pH. Chemical Structure"],"precautions":["PRECAUTIONS General EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is for external use only. Avoid contact with the eyes. If irritation develops, the cream should be discontinued and appropriate therapy instituted. Information for Patients Patients should be told to use EXELDERM CREAM as directed by the physician, to use it externally only, and to avoid contact with the eyes. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies to determine carcinogenic potential have not been performed. In vitro studies have shown no mutagenic activity. Pregnancy There are no adequate and well-controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if clearly needed. Sulconazole nitrate has been shown to be embryotoxic in rats when given in doses of 125 times the adult human dose (in mg/kg). The drug was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day. Sulconazole nitrate given orally to rats at a dose 125 times the human dose resulted in prolonged gestation and dystocia. Several females died during the prenatal period, most likely due to labor complications. Nursing Mothers It is not known whether sulconazole nitrate is excreted in human milk. Caution should be exercised when sul- conazole nitrate is administered to a nursing woman. Pediatric Use Safety and effectiveness in children have not been established. Geriatric Use Clinical studies of EXELDERM CREAM, 1.0%, did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients."],"how_supplied":["HOW SUPPLIED EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is a smooth, glossy white to off-white cream having a slight characteristic odor. It is supplied as follows: 60 g tube – NDC 69489-711-60 Avoid excessive heat, above 40° C (104° F). To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. JOURNEY ® MEDICAL CORPORATION Manufactured for: Journey Medical Corp. Scottsdale, AZ 85258 www.JMCderm.com 141113 Revised March 2021"],"geriatric_use":["Geriatric Use Clinical studies of EXELDERM CREAM, 1.0%, did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients."],"pediatric_use":["Pediatric Use Safety and effectiveness in children have not been established."],"effective_time":"20220719","nursing_mothers":["Nursing Mothers It is not known whether sulconazole nitrate is excreted in human milk. Caution should be exercised when sul- conazole nitrate is administered to a nursing woman."],"clinical_studies":["CLINICAL STUDIES In a vehicle-controlled study for the treatment of tinea pedis (moccasin type) due to T. rubrum , after 4 to 6 weeks of treatment 69% of patients on the active drug and 19% of patients on the drug vehicle had become KOH and culture negative. In addition, 68% of patients on the active drug and 20% of patients on the drug vehicle showed a good or excellent clinical response."],"adverse_reactions":["ADVERSE REACTIONS There were no systemic effects and only infrequent cutaneous adverse reactions in 1185 patients treated with sulconazole nitrate cream in controlled clinical trials. Approximately 3% of these patients reported itching, 3% burning or stinging, and 1% redness. These complaints did not usually interfere with treatment."],"contraindications":["CONTRAINDICATIONS EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of its ingredients."],"general_precautions":["General EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is for external use only. Avoid contact with the eyes. If irritation develops, the cream should be discontinued and appropriate therapy instituted."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Sulconazole nitrate is an imidazole derivative with broad-spectrum antifungal activity that inhibits the growth in vitro of the common pathogenic dermatophytes including Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum and Microsporum canis. It also inhibits (in vitro) the organism responsible for tinea versicolor, Malassezia furfur. Sulconazole nitrate has been shown to be active in vitro against the following microorganisms, although clinical efficacy has not been established: Candida albicans and certain gram-positive bacteria. A modified Draize test showed no allergic contact dermatitis and a phototoxicity study showed no phototoxic or photoallergic reaction to sulconazole nitrate cream. Maximization tests with sulconazole nitrate cream showed no evidence of contact sensitization or irritation."],"indications_and_usage":["INDICATIONS AND USAGE EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is an antifungal agent indicated for the treatment of tinea pedis (athlete's foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagro-phytes, Epidermophyton floccosum, and Microsporum canis,* and for the treatment of tinea versicolor. *Efficacy for this organism in the organ system was studied in fewer than ten infections."],"information_for_patients":["Information for Patients Patients should be told to use EXELDERM CREAM as directed by the physician, to use it externally only, and to avoid contact with the eyes."],"spl_unclassified_section":["(sulconazole nitrate, USP) Cream , 1.0% Rx only For topical use only. Not for ophthalmic use."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION A small amount of cream should be gently massaged into the affected and surrounding skin areas once or twice daily, except in tinea pedis, where administration should be twice daily. Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, tinea corporis/cruris and tinea versicolor should be treated for 3 weeks and tinea pedis for 4 weeks to reduce the possibility of recurrence. If significant clinical improvement is not seen after 4 to 6 weeks of treatment, an alternate diagnosis should be considered."],"spl_product_data_elements":["Exelderm Sulconazole Nitrate Sulconazole Nitrate SULCONAZOLE Propylene glycol Stearyl alcohol Isopropyl myristate Cetyl alcohol Polysorbate 60 Sorbitan monostearate Glyceryl monostearate PEG-100 stearate Ascorbyl palmitate Water Sodium hydroxide Nitric acid"],"package_label_principal_display_panel":["Principal Display Panel – 60 g Carton Label Exelderm ® (sulconazole nitrate, USP) Cream, 1.0% NDC 69489-711-60 Net Wt. 60 g JOURNEY MEDICAL CORPORATION 60 gram Carton Label","Principal Display Panel – 60 gram Tube Label Exelderm ® (sulconazole nitrate, USP) Cream, 1.0% Avoid excessive heat, above 40°C (104° F). NDC 69489-711-60 Rx only Net Wt. 60 g For topical use only. Not for ophthalmic use. 60 gram Tube Label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies to determine carcinogenic potential have not been performed. In vitro studies have shown no mutagenic activity."]},"tags":[{"label":"Azole Antifungal","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Cytochrome P450 2C19","category":"target"},{"label":"CYP2C19","category":"gene"},{"label":"CYP3A4","category":"gene"},{"label":"SLC6A4","category":"gene"},{"label":"D01AC09","category":"atc"},{"label":"Topical","category":"route"},{"label":"Cream","category":"form"},{"label":"Solution","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Pityriasis versicolor","category":"indication"},{"label":"Tinea corporis","category":"indication"},{"label":"Tinea cruris","category":"indication"},{"label":"Tinea pedis","category":"indication"},{"label":"Journey","category":"company"},{"label":"Approved 1980s","category":"decade"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antifungal Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"HERPES ZOSTER","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"HYPOTENSION","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"ABNORMAL DREAMS","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"ACUTE KIDNEY INJURY","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"ALTERED STATE OF CONSCIOUSNESS","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"ANXIETY","source":"FDA FAERS","actionTaken":"1 reports"}],"commonSideEffects":[{"effect":"itching","drugRate":"1%","severity":"mild","_validated":true},{"effect":"burning or stinging","drugRate":"1%","severity":"mild","_validated":true}],"specialPopulations":{"Pregnancy":"There are no adequate and well-controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if clearly needed. Sulconazole nitrate has been shown to be embryotoxic in rats when given in doses of 125 times the adult human dose (in mg/kg). The drug was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day.Sulconazole nitrate given orally to rats at dose 125 times the human dose resulted in prolonged gestation and dystocia. Several females died.","Geriatric use":"Clinical studies of SULCONAZOLE NITRATE topical solution 1.0%, did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients.","Paediatric use":"Safety and effectiveness in children have not been established.Efficacy for this organism in the organ system was studied in fewer than 10 infections."}},"trials":[],"aliases":[],"company":"Journey","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=SULCONAZOLE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:45:26.051766+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:45:33.565872+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:45:25.177170+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SULCONAZOLE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:45:33.919299+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:45:23.709303+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:45:23.709327+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:45:35.490434+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1221/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:45:34.690027+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA018737","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:45:23.709331+00:00"}},"allNames":"exelderm","offLabel":[],"synonyms":["sulconazole mononitrate","sulconazole","sulconazole nitrate"],"timeline":[{"date":"1985-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from RANBAXY to Journey"},{"date":"1985-08-30","type":"positive","source":"DrugCentral","milestone":"FDA approval (Ranbaxy)"},{"date":"1989-02-28","type":"positive","source":"FDA Orange Book","milestone":"Exelderm approved — 1%"}],"aiSummary":"Exelderm (Sulconazole) is a small molecule azole antifungal medication originally developed by Ranbaxy and currently owned by Journey. It targets the Cytochrome P450 2C19 enzyme and is FDA-approved for treating various fungal infections such as pityriasis versicolor, tinea corporis, tinea cruris, and tinea pedis. Exelderm is off-patent and has no active Orange Book patents, indicating it is available as a generic medication. As an azole antifungal, it works by inhibiting the growth of fungi. Key safety considerations include potential skin irritation and allergic reactions.","approvals":[{"date":"1985-08-30","orphan":false,"company":"RANBAXY","regulator":"FDA"}],"brandName":"Exelderm","ecosystem":[{"indication":"Pityriasis versicolor","otherDrugs":[{"name":"acrisorcin","slug":"acrisorcin","company":"Schering"},{"name":"butenafine","slug":"butenafine","company":"Mylan"},{"name":"carbamide","slug":"carbamide","company":"Hospira"},{"name":"ciclopirox","slug":"ciclopirox","company":"Medimetriks Pharms"}],"globalPrevalence":null},{"indication":"Tinea corporis","otherDrugs":[{"name":"benzocaine","slug":"benzocaine","company":""},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone dipropionate","slug":"betamethasone-dipropionate","company":"Schering"},{"name":"butenafine","slug":"butenafine","company":"Mylan"}],"globalPrevalence":null},{"indication":"Tinea cruris","otherDrugs":[{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone dipropionate","slug":"betamethasone-dipropionate","company":"Schering"},{"name":"butenafine","slug":"butenafine","company":"Mylan"},{"name":"ciclopirox","slug":"ciclopirox","company":"Medimetriks Pharms"}],"globalPrevalence":null},{"indication":"Tinea pedis","otherDrugs":[{"name":"benzocaine","slug":"benzocaine","company":""},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone dipropionate","slug":"betamethasone-dipropionate","company":"Schering"},{"name":"butenafine","slug":"butenafine","company":"Mylan"}],"globalPrevalence":640000000}],"mechanism":{"target":"Cytochrome P450 2C19","novelty":"Follow-on","targets":[{"gene":"CYP2C19","source":"DrugCentral","target":"Cytochrome P450 2C19","protein":"Cytochrome P450 2C19"},{"gene":"CYP3A4","source":"DrugCentral","target":"Cytochrome P450 3A4","protein":"Cytochrome P450 3A4"},{"gene":"SLC6A4","source":"DrugCentral","target":"Sodium-dependent serotonin transporter","protein":"Sodium-dependent serotonin transporter"},{"gene":"TBXAS1","source":"DrugCentral","target":"Thromboxane-A synthase","protein":"Thromboxane-A synthase"},{"gene":"CYP2C9","source":"DrugCentral","target":"Cytochrome P450 2C9","protein":"Cytochrome P450 2C9"},{"gene":"CHRM4","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M4","protein":"Muscarinic acetylcholine receptor M4"},{"gene":"CYP1A2","source":"DrugCentral","target":"Cytochrome P450 1A2","protein":"Cytochrome P450 1A2"},{"gene":"ADRA2C","source":"DrugCentral","target":"Alpha-2C adrenergic receptor","protein":"Alpha-2C adrenergic receptor"},{"gene":"CHRM3","source":"DrugCentral","target":"Muscarinic acetylcholine receptor M3","protein":"Muscarinic acetylcholine receptor M3"},{"gene":"CYP2D6","source":"DrugCentral","target":"Cytochrome P450 2D6","protein":"Cytochrome P450 2D6"}],"modality":"Small Molecule","drugClass":"Azole Antifungal","explanation":"","oneSentence":"","technicalDetail":"Sulconazole inhibits the enzyme lanosterol 14α-demethylase, which is involved in the conversion of lanosterol to ergosterol in the fungal cell membrane, ultimately disrupting fungal cell membrane synthesis and function."},"commercial":{"launchDate":"1985","_launchSource":"DrugCentral (FDA 1985-08-30, RANBAXY)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2495","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=SULCONAZOLE","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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2030","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"sulconazole","indications":{"approved":[{"name":"Pityriasis versicolor","source":"DrugCentral","snomedId":56454009,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Tinea corporis","source":"DrugCentral","snomedId":84849002,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Tinea cruris","source":"DrugCentral","snomedId":399029005,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned"},{"name":"Tinea pedis","source":"DrugCentral","snomedId":6020002,"regulator":"FDA","eligibility":"No specific eligibility criteria mentioned (not proven effective)","usPrevalence":null,"globalPrevalence":640000000,"prevalenceMethod":"curated","prevalenceSource":"BMC Public Health, 2025 (PMID:40993673)"}],"offLabel":[],"pipeline":[]},"currentOwner":"Journey","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — 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