{"id":"clocortolone-pivalate","rwe":[{"pmid":"29999716","year":"2006","title":"Clocortolone Pivalate.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"35495240","year":"2020","title":"Understanding the correlation between structure and dynamics of clocortolone pivalate by solid state NMR measurement.","finding":"","journal":"RSC advances","studyType":"Clinical Study"},{"pmid":"25007376","year":"2014","title":"Transitioning from brand to generic with topical products and the importance of maintaining the formulation and therapeutic profiles of the original product: focus on clocortolone pivalate 0.1% cream.","finding":"","journal":"Journal of drugs in dermatology : JDD","studyType":"Clinical Study"},{"pmid":"24809882","year":"2014","title":"A study to assess the occlusivity and moisturization potential of three topical corticosteroid products using the skin trauma after razor shaving (STARS) bioassay.","finding":"","journal":"Journal of drugs in dermatology : JDD","studyType":"Clinical Study"},{"pmid":"23377405","year":"2013","title":"The role of a midpotency topical corticosteroid and the clinical relevance of formulation characteristics in the management of commonly encountered eczematous and inflammatory dermatoses in adults and children: focus on the pharmacologic properties of clocortolone pivalate 0.1% cream.","finding":"","journal":"Journal of drugs in dermatology : JDD","studyType":"Clinical Study"}],"_fda":{"id":"0b06ddbb-6100-464f-9266-ace704fe8a40","set_id":"88d9a7cf-31b5-4b85-9827-0ecce328e6a0","openfda":{"unii":["QBL8IZH14X"],"route":["TOPICAL"],"rxcui":["197520"],"spl_id":["0b06ddbb-6100-464f-9266-ace704fe8a40"],"brand_name":["Clocortolone Pivalate"],"spl_set_id":["88d9a7cf-31b5-4b85-9827-0ecce328e6a0"],"package_ndc":["51672-4166-6","51672-4166-8"],"product_ndc":["51672-4166"],"generic_name":["CLOCORTOLONE PIVALATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CLOCORTOLONE PIVALATE"],"manufacturer_name":["Taro Pharmaceuticals U.S.A., inc."],"application_number":["ANDA206370"],"is_original_packager":[true]},"version":"2","pregnancy":["Pregnancy Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time."],"overdosage":["OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS )."],"description":["DESCRIPTION Clocortolone pivalate cream USP, 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of benzyl alcohol, carbomer homopolymer Type B (carbopol 974P), edetate disodium, methylparaben, mineral oil, polyoxyl 40 stearate (MYRJ 40S), propylparaben, purified water, sodium hydroxide, stearyl alcohol and white petrolatum. Chemically, clocortolone pivalate is 9-chloro-6α-fluoro-11β, 21-dihydroxy-16αmethylpregna-1, 4-diene-3, 20-dione 21-pivalate. Its structure is as follows: Chemical Structure"],"precautions":["PRECAUTIONS General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS-Pediatric Use ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings. Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results. Pregnancy Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman. Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children."],"how_supplied":["HOW SUPPLIED Clocortolone Pivalate Cream USP, 0.1% is supplied in 45 gram and 90 gram tubes. 45 gram tube NDC 51672-4166-6 90 gram tube NDC 51672-4166-8 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing."],"pediatric_use":["Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children."],"effective_time":"20211221","nursing_mothers":["Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman."],"laboratory_tests":["Laboratory Tests The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test"],"pharmacokinetics":["Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile."],"adverse_reactions":["ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin atrophy Striae Miliaria"],"contraindications":["CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation."],"how_supplied_table":["<table width=\"60%\" styleCode=\"Noautorules\"><col width=\"60%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"right\" valign=\"top\"/><tbody><tr><td>45 gram tube</td><td>NDC 51672-4166-6</td></tr><tr><td>90 gram tube</td><td>NDC 51672-4166-8</td></tr></tbody></table>"],"general_precautions":["General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS-Pediatric Use ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled."],"storage_and_handling":["STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile."],"indications_and_usage":["INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses."],"information_for_patients":["Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. 2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. 4. Patients should report any signs of local adverse reactions especially under occlusive dressing. 5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings."],"spl_unclassified_section":["Rx Only For Topical Use Only WARNING: KEEP OUT OF REACH OF CHILDREN","Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 Revised: July 2020 20967-0720-1 76"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Apply clocortolone pivalate cream USP, 0.1% sparingly to the affected areas three times a day and rub in gently. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate anti-microbial therapy instituted."],"spl_product_data_elements":["Clocortolone Pivalate Clocortolone Pivalate Clocortolone Pivalate Clocortolone benzyl alcohol carbomer homopolymer type b (allyl pentaerythritol crosslinked) edetate disodium methylparaben mineral oil polyoxyl 40 stearate propylparaben water sodium hydroxide stearyl alcohol petrolatum"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 90 g Tube Carton NDC 51672-4166-8 90 g Clocortolone Pivalate Cream USP, 0.1% For Topical Use Only Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 90 g Tube Carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results."]},"tags":[{"label":"Corticosteroid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Glucocorticoid receptor","category":"target"},{"label":"NR3C1","category":"gene"},{"label":"D07AB21","category":"atc"},{"label":"Topical","category":"route"},{"label":"Cream","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Atopic dermatitis","category":"indication"},{"label":"Contact dermatitis","category":"indication"},{"label":"Discoid lupus erythematosus","category":"indication"},{"label":"Eruption of skin","category":"indication"},{"label":"Granuloma annulare","category":"indication"},{"label":"Lichen simplex chronicus","category":"indication"},{"label":"Legacy Pharma","category":"company"},{"label":"Approved 1970s","category":"decade"},{"label":"Anti-Inflammatory Agents","category":"pharmacology"},{"label":"Glucocorticoids","category":"pharmacology"},{"label":"Hormones","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"5 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"5 reports"},{"date":"","signal":"CARDIAC DISORDER","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"CONDITION AGGRAVATED","source":"FDA FAERS","actionTaken":"3 reports"},{"date":"","signal":"CONJUNCTIVITIS","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"DERMATITIS ATOPIC","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"ERYTHEMA","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"PALPITATIONS","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"SKIN EROSION","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"SKIN EXFOLIATION","source":"FDA FAERS","actionTaken":"2 reports"}],"commonSideEffects":[{"effect":"Skin atrophy","drugRate":"reported","severity":"unknown"},{"effect":"Miliaria","drugRate":"reported","severity":"unknown"},{"effect":"Striae","drugRate":"reported","severity":"unknown"},{"effect":"Secondary infection","drugRate":"reported","severity":"unknown"},{"effect":"Maceration of the skin","drugRate":"reported","severity":"unknown"},{"effect":"Allergic contact dermatitis","drugRate":"reported","severity":"unknown"},{"effect":"Perioral dermatitis","drugRate":"reported","severity":"unknown"},{"effect":"Hypopigmentation","drugRate":"reported","severity":"unknown"},{"effect":"Acneiform eruptions","drugRate":"reported","severity":"unknown"},{"effect":"Hypertrichosis","drugRate":"reported","severity":"unknown"},{"effect":"Folliculitis","drugRate":"reported","severity":"unknown"},{"effect":"Dryness","drugRate":"reported","severity":"unknown"},{"effect":"Irritation","drugRate":"reported","severity":"unknown"},{"effect":"Itching","drugRate":"reported","severity":"unknown"},{"effect":"Burning","drugRate":"reported","severity":"unknown"}],"contraindications":["Adrenal cortical hypofunction","Atrophoderma","Peripheral vascular disease","Telangiectasia disorder"],"specialPopulations":{"Pregnancy":"Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the risk.","Paediatric use":"Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushings syndrome than mature patients because of larger skin surface area body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushings syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain."}},"trials":[],"aliases":[],"company":"Legacy Pharma","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-04-17","unitCost":"$3.2393/GM","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$1,182","description":"CLOCORTOLONE PIVALATE 0.1% CRM","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CLOCORTOLONE PIVALATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:37:14.253968+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Clocortolone Pivalate","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:37:21.282805+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:37:19.619978+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:37:13.376588+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CLOCORTOLONE PIVALATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:37:19.951822+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:37:12.916920+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:37:12.916949+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":"2026-04-20T00:37:21.702613+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Glucocorticoid receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:37:21.282736+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200975/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:37:20.938009+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA206370","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:37:12.916954+00:00"}},"allNames":"cloderm","offLabel":[],"synonyms":["clocortolone pivalate","clocortolone trimethylacetate"],"timeline":[{"date":"1977-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from PROMIUS PHARMA LLC to Legacy Pharma"},{"date":"1977-08-22","type":"positive","source":"DrugCentral","milestone":"FDA approval (Promius Pharma Llc)"},{"date":"2020-04-21","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Cloderm (CLOCORTOLONE PIVALATE) is a corticosteroid medication developed by PROMIUS PHARMA LLC and currently owned by Legacy Pharma. It targets the glucocorticoid receptor and is used to treat various skin conditions, including atopic dermatitis, contact dermatitis, and plaque psoriasis. Cloderm is a small molecule corticosteroid that has been FDA-approved since 1977 and is now off-patent. It is available as a generic medication with a single manufacturer. Key safety considerations include the potential for skin thinning and other corticosteroid-related side effects.","approvals":[{"date":"1977-08-22","orphan":false,"company":"PROMIUS PHARMA LLC","regulator":"FDA"}],"brandName":"Cloderm","ecosystem":[{"indication":"Atopic dermatitis","otherDrugs":[{"name":"abrocitinib","slug":"abrocitinib","company":"PFIZER Inc"},{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"}],"globalPrevalence":null},{"indication":"Contact dermatitis","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"benzoyl peroxide","slug":"benzoyl-peroxide","company":"Valeant Intl"}],"globalPrevalence":324000000},{"indication":"Discoid lupus erythematosus","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone benzoate","slug":"betamethasone-benzoate","company":"Parke Davis"}],"globalPrevalence":2400000},{"indication":"Eruption of skin","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"benzoyl peroxide","slug":"benzoyl-peroxide","company":"Valeant Intl"}],"globalPrevalence":null},{"indication":"Granuloma annulare","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"benzoyl peroxide","slug":"benzoyl-peroxide","company":"Valeant Intl"}],"globalPrevalence":null},{"indication":"Lichen simplex chronicus","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone benzoate","slug":"betamethasone-benzoate","company":"Parke Davis"}],"globalPrevalence":null},{"indication":"Plaque psoriasis","otherDrugs":[{"name":"adalimumab","slug":"adalimumab","company":"Abbvie Inc"},{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"alefacept","slug":"alefacept","company":"Astellas"},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"}],"globalPrevalence":125000000},{"indication":"Primary cutaneous T-cell lymphoma","otherDrugs":[{"name":"alclometasone dipropionate","slug":"alclometasone-dipropionate","company":""},{"name":"amcinonide","slug":"amcinonide","company":"Astellas"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone benzoate","slug":"betamethasone-benzoate","company":"Parke Davis"}],"globalPrevalence":null}],"mechanism":{"target":"Glucocorticoid receptor","novelty":"Follow-on","targets":[{"gene":"NR3C1","source":"DrugCentral","target":"Glucocorticoid receptor","protein":"Glucocorticoid receptor"}],"moaClass":"Corticosteroid Hormone Receptor Agonists","modality":"Small Molecule","drugClass":"Corticosteroid","explanation":"","oneSentence":"","technicalDetail":"Cloderm (CLOCORTOLONE PIVALATE) is a synthetic corticosteroid that selectively binds to the glucocorticoid receptor (GR), leading to the inhibition of transcription factors and the suppression of inflammatory gene expression."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Clocortolone","title":"Clocortolone","extract":"Clocortolone (Cloderm) is a topical steroid. It is used in the form of an ester, clocortolone pivalate, and applied as a cream. It is used for the treatment of dermatitis and is considered a medium-strength corticosteroid. It is unusual among steroids in that it contains a chlorine atom and a fluorine atom."},"commercial":{"launchDate":"1977","_launchSource":"DrugCentral (FDA 1977-08-22, PROMIUS PHARMA LLC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4606","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=CLOCORTOLONE%20PIVALATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CLOCORTOLONE PIVALATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Clocortolone","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T10:09:54.235941","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:37:23.762199+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"hydrocortisone butyrate","drugSlug":"hydrocortisone-butyrate","fdaApproval":"1982-03-31","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"flumetasone","drugSlug":"flumetasone","fdaApproval":"","relationship":"same-class"},{"drugName":"fluorometholone","drugSlug":"fluorometholone","fdaApproval":"1972-01-12","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"desonide","drugSlug":"desonide","fdaApproval":"1972-01-04","patentExpiry":"Aug 13, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"triamcinolone","drugSlug":"triamcinolone","fdaApproval":"1957-12-03","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"alclometasone dipropionate","drugSlug":"alclometasone-dipropionate","fdaApproval":"1982-12-14","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"hydrocortisone probutate","drugSlug":"hydrocortisone-probutate","fdaApproval":"1997-02-28","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"dexamethasone","drugSlug":"dexamethasone","fdaApproval":"1958-10-30","patentExpiry":"Oct 7, 2036","patentStatus":"Patent protected","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"clocortolone pivalate","indications":{"approved":[{"name":"Atopic dermatitis","source":"DrugCentral","snomedId":24079001,"regulator":"FDA","eligibility":"adults and children 2 years of age and older"},{"name":"Contact dermatitis","source":"DrugCentral","snomedId":40275004,"regulator":"FDA","eligibility":"adults and children 2 years of age and older","usPrevalence":null,"globalPrevalence":324000000,"prevalenceMethod":"curated","prevalenceSource":"Contact Dermatitis, 2025 (PMID:40107276)"},{"name":"Discoid lupus erythematosus","source":"DrugCentral","snomedId":200938002,"regulator":"FDA","eligibility":"adults and children 2 years of age and older","usPrevalence":null,"globalPrevalence":2400000,"prevalenceMethod":"curated","prevalenceSource":"Orphanet (ORPHANET)"},{"name":"Eruption of skin","source":"DrugCentral","snomedId":271807003,"regulator":"FDA","eligibility":"adults and children 2 years of age and older"},{"name":"Granuloma annulare","source":"DrugCentral","snomedId":65508009,"regulator":"FDA","eligibility":"adults and children 2 years of age and older"},{"name":"Lichen simplex chronicus","source":"DrugCentral","snomedId":53891004,"regulator":"FDA","eligibility":"adults and children 2 years of age and older"},{"name":"Plaque psoriasis","source":"DrugCentral","snomedId":200965009,"regulator":"FDA","eligibility":"adults and children 2 years of age and older","usPrevalence":7500000,"globalPrevalence":125000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Primary cutaneous T-cell lymphoma","source":"DrugCentral","snomedId":400122007,"regulator":"FDA","eligibility":"adults and children 2 years of age and older"},{"name":"Pruritus ani","source":"DrugCentral","snomedId":90446007,"regulator":"FDA","eligibility":"adults and children 2 years of age and older"},{"name":"Pruritus of genital organs","source":"DrugCentral","snomedId":267802000,"regulator":"FDA","eligibility":"adults and children 2 years of age and older"},{"name":"Scalp psoriasis","source":"DrugCentral","snomedId":238608008,"regulator":"FDA","usPrevalence":7500000,"globalPrevalence":125000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Seborrheic dermatitis","source":"DrugCentral","snomedId":50563003,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"currentOwner":"Legacy Pharma","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"hydrocortisone-butyrate","brandName":"hydrocortisone butyrate","genericName":"hydrocortisone butyrate","approvalYear":"1982","relationship":"same-class"},{"drugId":"flumetasone","brandName":"flumetasone","genericName":"flumetasone","approvalYear":"","relationship":"same-class"},{"drugId":"fluorometholone","brandName":"fluorometholone","genericName":"fluorometholone","approvalYear":"1972","relationship":"same-class"},{"drugId":"desonide","brandName":"desonide","genericName":"desonide","approvalYear":"1972","relationship":"same-class"},{"drugId":"triamcinolone","brandName":"triamcinolone","genericName":"triamcinolone","approvalYear":"1957","relationship":"same-class"},{"drugId":"alclometasone-dipropionate","brandName":"alclometasone dipropionate","genericName":"alclometasone dipropionate","approvalYear":"1982","relationship":"same-class"},{"drugId":"hydrocortisone-probutate","brandName":"hydrocortisone probutate","genericName":"hydrocortisone probutate","approvalYear":"1997","relationship":"same-class"},{"drugId":"dexamethasone","brandName":"dexamethasone","genericName":"dexamethasone","approvalYear":"1958","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04358770","phase":"PHASE1","title":"Bio-equivalence Vasoconstriction Activity Study for Topically Applied Clocortolone Pivalate 0.1% Cream","status":"COMPLETED","sponsor":"Sun Pharmaceutical Industries, Inc.","startDate":"2018-03-02","conditions":["Bioequivalence Study"],"enrollment":124,"completionDate":"2018-05-11"},{"nctId":"NCT01714544","phase":"PHASE4","title":"Study of the Efficacy of Cloderm® Cream in the Treatment of Moderate Plaque Psoriasis","status":"COMPLETED","sponsor":"Promius Pharma, LLC","startDate":"2012-10","conditions":["Psoriasis"],"enrollment":60,"completionDate":""}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Topical","formulation":"Cream","formulations":[{"form":"CREAM","route":"TOPICAL","productName":"Clocortolone Pivalate"},{"form":"CREAM","route":"TOPICAL","productName":"Cloderm"},{"form":"CREAM","route":"TOPICAL","productName":"Clocortolone Pivalate Cream"},{"form":"CREAM","route":"TOPICAL","productName":"clocortolone pivalate"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000146872","MMSL":"213051","NDDF":"002182","UNII":"QBL8IZH14X","VUID":"4018552","CHEBI":"CHEBI:59582","VANDF":"4018552","INN_ID":"2113","RXNORM":"21249","UMLSCUI":"C0055900","chemblId":"CHEMBL1200975","ChEMBL_ID":"CHEMBL1200975","KEGG_DRUG":"D02287","DRUGBANK_ID":"DB00838","PUBCHEM_CID":"5282493","SNOMEDCT_US":"17503004","SECONDARY_CAS_RN":"4828-27-7","MESH_SUPPLEMENTAL_RECORD_UI":"C007088"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"1977-","companyName":"Promius Pharma Llc","relationship":"Original Developer"},{"period":"present","companyName":"Legacy Pharma","relationship":"Current Owner"}],"publicationCount":14,"therapeuticAreas":["Oncology"],"atcClassification":{"source":"DrugCentral","atcCode":"D07AB21","allCodes":["D07AB21"]},"biosimilarFilings":[],"originalDeveloper":"Promius Pharma Llc","recentPublications":[{"date":"2006","pmid":"29999716","title":"Clocortolone Pivalate.","journal":""},{"date":"2020 Jan 24","pmid":"35495240","title":"Understanding the correlation between structure and dynamics of clocortolone pivalate by solid state NMR measurement.","journal":"RSC advances"},{"date":"2014 Jul","pmid":"25007376","title":"Transitioning from brand to generic with topical products and the importance of maintaining the formulation and therapeutic profiles of the original product: focus on clocortolone pivalate 0.1% cream.","journal":"Journal of drugs in dermatology : JDD"},{"date":"2014 May","pmid":"24809882","title":"A study to assess the occlusivity and moisturization potential of three topical corticosteroid products using the skin trauma after razor shaving (STARS) bioassay.","journal":"Journal of drugs in dermatology : JDD"},{"date":"2013 Feb","pmid":"23377405","title":"The role of a midpotency topical corticosteroid and the clinical relevance of formulation characteristics in the management of commonly encountered eczematous and inflammatory dermatoses in adults and children: focus on the pharmacologic properties of clocortolone pivalate 0.1% cream.","journal":"Journal of drugs in dermatology : JDD"}],"companionDiagnostics":[],"genericManufacturers":1,"_genericFilersChecked":true,"genericManufacturerList":["Taro"],"status":"approved","companyName":"Legacy Pharma","companyId":"legacy-pharma","modality":"Small molecule","firstApprovalDate":"1977","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1977-08-22T00:00:00.000Z","mah":"PROMIUS PHARMA LLC","brand_name_local":null,"application_number":""},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":"1977-08-22T00:00:00.000Z","mah":"PROMIUS PHARMA LLC","brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":"1977-08-22T00:00:00.000Z","mah":"PROMIUS PHARMA LLC","brand_name_local":null,"application_number":null},{"country_code":"SA","regulator":"SFDA","status":"likely_approved","approval_date":"1977-08-22T00:00:00.000Z","mah":"PROMIUS PHARMA LLC","brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":"1977-08-22T00:00:00.000Z","mah":"PROMIUS PHARMA LLC","brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":"1977-08-22T00:00:00.000Z","mah":"PROMIUS PHARMA LLC","brand_name_local":null,"application_number":null},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2020-04-21T00:00:00.000Z","mah":"TARO","brand_name_local":null,"application_number":"ANDA206370"},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:37:23.762199+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}