{"id":"fluocinonide","rwe":[],"_fda":{"id":"785b93c3-9489-4d35-9dc5-5f64d5c604ee","set_id":"08d69d3f-c628-4b08-a7ae-0f7ec5599d3a","openfda":{"nui":["N0000175576","N0000175450"],"upc":["0372578087067"],"unii":["2W4A77YPAN"],"route":["TOPICAL"],"rxcui":["485647"],"spl_id":["785b93c3-9489-4d35-9dc5-5f64d5c604ee"],"brand_name":["FLUOCINONIDE"],"spl_set_id":["08d69d3f-c628-4b08-a7ae-0f7ec5599d3a"],"package_ndc":["70771-1393-2","70771-1393-3","70771-1393-5"],"product_ndc":["70771-1393"],"generic_name":["FLUOCINONIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["FLUOCINONIDE"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"manufacturer_name":["Zydus Lifesciences Limited"],"application_number":["ANDA208989"],"is_original_packager":[true]},"version":"4","effective_time":"20240816","spl_unclassified_section":[""],"spl_product_data_elements":["FLUOCINONIDE FLUOCINONIDE FLUOCINONIDE FLUOCINONIDE ANHYDROUS CITRIC ACID CARBOMER HOMOPOLYMER TYPE C DIETHYLENE GLYCOL MONOETHYL ETHER DIISOPROPANOLAMINE GLYCERYL MONOSTEARATE PEG-100 STEARATE PROPYLENE GLYCOL WATER white to off-white"],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1393-2 Fluocinonide Cream USP, 0.1% Rx only 30 g Fluocinonide Cream"]},"tags":[{"label":"Corticosteroid","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Glucocorticoid receptor","category":"target"},{"label":"NR3C1","category":"gene"},{"label":"C05AA11","category":"atc"},{"label":"Topical","category":"route"},{"label":"Cream","category":"form"},{"label":"Gel","category":"form"},{"label":"Ointment","category":"form"},{"label":"Solution","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","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":"Inflammatory dermatosis","category":"indication"},{"label":"Approved 1970s","category":"decade"},{"label":"Anti-Allergic Agents","category":"pharmacology"},{"label":"Anti-Inflammatory Agents","category":"pharmacology"},{"label":"Glucocorticoids","category":"pharmacology"},{"label":"Hormones","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"748 reports"},{"date":"","signal":"PSORIASIS","source":"FDA FAERS","actionTaken":"546 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"442 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"410 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"282 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"280 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"277 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"272 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"269 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"255 reports"}],"commonSideEffects":[{"effect":"Burning","drugRate":"","severity":"common","organSystem":""},{"effect":"Itching","drugRate":"","severity":"common","organSystem":""},{"effect":"Irritation","drugRate":"","severity":"common","organSystem":""},{"effect":"Dryness","drugRate":"","severity":"common","organSystem":""},{"effect":"Folliculitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Hypertrichosis","drugRate":"","severity":"common","organSystem":""},{"effect":"Acneiform eruptions","drugRate":"","severity":"common","organSystem":""},{"effect":"Hypopigmentation","drugRate":"","severity":"common","organSystem":""},{"effect":"Perioral dermatitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Allergic contact dermatitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Maceration of the skin","drugRate":"","severity":"common","organSystem":""},{"effect":"Secondary infection","drugRate":"","severity":"common","organSystem":""},{"effect":"Skin atrophy","drugRate":"","severity":"common","organSystem":""},{"effect":"Striae","drugRate":"","severity":"common","organSystem":""},{"effect":"Miliaria","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Diabetes mellitus","Hypercortisolism","Hyperglycemia","Hypopituitarism","Infection of skin AND/OR subcutaneous tissue"],"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 potential risk to the fetus.","Geriatric use":"Clinical studies of VANOS Cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious.","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 to 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, and other effects."},"seriousAdverseEvents":[]},"trials":[],"aliases":[],"patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.3957/GM","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$144","description":"FLUOCINONIDE 0.05% CREAM","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=FLUOCINONIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:14:35.284203+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:14:41.696192+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:14:34.386055+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FLUOCINONIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:14:42.059902+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:14:32.911918+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:14:32.911962+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:14:32.911969+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":"2026-04-20T01:14:43.578348+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Glucocorticoid receptor agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:14:43.121419+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1501/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:14:42.770192+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA208989","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:14:32.911973+00:00"}},"allNames":"lidex","offLabel":[],"synonyms":["fluocinonide","flucetonide","fluocinolide","fluocinolide acetate","fluocinolone acetonide acetate"],"timeline":[{"date":"1971-06-30","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"1984-04-06","type":"positive","source":"FDA Orange Book","milestone":"Lidex approved — 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"1984-06-26","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Sun Pharma Canada)"},{"date":"2005-02-11","type":"positive","source":"FDA Orange Book","milestone":"Vanos approved — 0.1%"},{"date":"2018-04-23","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 13 manufacturers approved"}],"aiSummary":"Lidex (Fluocinonide) is a corticosteroid medication that targets the glucocorticoid receptor to reduce inflammation. Originally developed and currently owned by Alvogen, it has been FDA-approved since 1971 for various skin conditions, including atopic dermatitis, contact dermatitis, and plaque psoriasis. As an off-patent medication, Lidex is available from multiple generic manufacturers. Key safety considerations include potential skin thinning and increased risk of infections. Lidex is a small molecule corticosteroid that works by binding to the glucocorticoid receptor, leading to anti-inflammatory effects.","approvals":[{"date":"1971-06-30","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Lidex","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":204050000},{"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":"Inflammatory dermatosis","otherDrugs":[{"name":"clobetasol propionate","slug":"clobetasol-propionate","company":"Fougera Pharms"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"hydrocortisone","slug":"hydrocortisone","company":"Merck"},{"name":"hydrocortisone acetate","slug":"hydrocortisone-acetate","company":"Merck"}],"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}],"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 [EPC]","explanation":"","oneSentence":"","technicalDetail":"Fluocinonide is a synthetic corticosteroid that acts as a potent inhibitor of phospholipase A2, leading to decreased production of pro-inflammatory mediators and subsequent anti-inflammatory effects."},"commercial":{"launchDate":"1971","_launchSource":"DrugCentral (FDA 1971-06-30, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1205","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=FLUOCINONIDE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FLUOCINONIDE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"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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