{"id":"fluocinolone","rwe":[{"pmid":"41894560","year":"2026","title":"Three-year follow-up after fluocinolone acetonide implant injected one month after dexamethasone implant for treating diabetic macular edema: the ILUVI1MOIS Study.","finding":"","journal":"Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde","studyType":"Clinical Study"},{"pmid":"41887289","year":"2026","title":"Fluocinolone Acetonide Implant as a Baseline Therapy for Diabetic Macular Edema: Results from the Randomized Phase 4 NEW DAY Study.","finding":"","journal":"Ophthalmology","studyType":"Clinical Study"},{"pmid":"41857335","year":"2026","title":"Use of intravitreal fluocinolone acetonide implant in inflammatory macular oedema.","finding":"","journal":"Eye (London, England)","studyType":"Clinical Study"},{"pmid":"41847416","year":"2026","title":"Acute postoperative complications after scleral fixation of Akreos AO60 intraocular lens.","finding":"","journal":"Journal of surgical case reports","studyType":"Clinical Study"},{"pmid":"41764699","year":"2026","title":"Prevalence and Risk Factors of Ocular Hypertension Following Fluocinolone Acetonide (Iluvien(®)) Intravitreal Injections: The \"SAFAC\" Study.","finding":"","journal":"Ophthalmology and therapy","studyType":"Clinical Study"}],"_fda":{"id":"390af125-04e3-1010-e063-6294a90a016d","set_id":"02352ed1-3568-441f-add8-45201351a11c","openfda":{"nui":["N0000175576","N0000175450"],"unii":["0CD5FD6S2M"],"route":["TOPICAL"],"rxcui":["1191310"],"spl_id":["390af125-04e3-1010-e063-6294a90a016d"],"brand_name":["Fluocinolone Acetonide"],"spl_set_id":["02352ed1-3568-441f-add8-45201351a11c"],"package_ndc":["51672-1365-2","51672-1365-4"],"product_ndc":["51672-1365"],"generic_name":["FLUOCINOLONE ACETONIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["FLUOCINOLONE ACETONIDE"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"manufacturer_name":["Sun Pharmaceutical Industries, Inc."],"application_number":["ANDA089124"],"is_original_packager":[true]},"version":"3","pregnancy":["Pregnancy Category C 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 Fluocinolone Acetonide Topical Solution USP, 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone Acetonide 0.01% Solution (each mL contains 0.1 mg Fluocinolone Acetonide) in a water-washable base containing citric acid and propylene glycol. 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. As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use. 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: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions, especially under occlusive dressing. 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 Category C 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 a 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 hypothalmic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalmic-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 Fluocinolone Acetonide Topical Solution USP, 0.01% is available in 20 mL (NDC 51672-1365-2) and 60 mL (NDC 51672-1365-4) bottles. STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing."],"pediatric_use":["Pediatric Use Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalmic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalmic-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":"20250703","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 a 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 Perioral dermatitis Itching Allergic contact dermatitis Irritation Maceration of the skin Dryness Secondary infection Folliculitis Skin atrophy Hypertrichosis Striae Acneiform eruptions Miliaria Hypopigmentation"],"contraindications":["CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation."],"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. As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use. 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."],"teratogenic_effects":["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."],"storage_and_handling":["STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, anti-pruritic 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 Fluocinolone Acetonide Topical Solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses."],"adverse_reactions_table":["<table width=\"75%\" styleCode=\"Noautorules\"><col width=\"20%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"left\" valign=\"top\"/><col width=\"40%\" align=\"left\" valign=\"top\"/><tbody><tr><td/><td>Burning</td><td>Perioral dermatitis</td></tr><tr><td/><td>Itching</td><td>Allergic contact dermatitis</td></tr><tr><td/><td>Irritation</td><td>Maceration of the skin</td></tr><tr><td/><td>Dryness</td><td>Secondary infection</td></tr><tr><td/><td>Folliculitis</td><td>Skin atrophy</td></tr><tr><td/><td>Hypertrichosis</td><td>Striae</td></tr><tr><td/><td>Acneiform eruptions</td><td>Miliaria</td></tr><tr><td/><td>Hypopigmentation</td><td/></tr></tbody></table>"],"information_for_patients":["Information for the Patient Patients using topical corticosteroids should receive the following information and instructions: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician. Patients should report any signs of local adverse reactions, especially under occlusive dressing. 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","To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda/gov/medwatch. Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 TARO is a registered trademark of Taro Pharmaceuticals U.S.A., Inc. Revised: May 2016 PK-7380-2 17"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Fluocinolone Acetonide Solution is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. In hairy sites, the hair should be parted to allow direct contact with the lesion. Occlusive dressing 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 antimicrobial therapy instituted."],"spl_product_data_elements":["Fluocinolone Acetonide fluocinolone acetonide CITRIC ACID MONOHYDRATE PROPYLENE GLYCOL FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton 60 mL NDC 51672-1365-4 Fluocinolone Acetonide Topical Solution USP, 0.01% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. Rx only TARO PRINCIPAL DISPLAY PANEL - 60 mL Bottle 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 [EPC]","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Topical","category":"route"},{"label":"Oil","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Active","category":"status"},{"label":"corticosteroid-responsive dermatoses","category":"indication"},{"label":"Eurofarma","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"602 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"369 reports"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"253 reports"},{"date":"","signal":"ERYTHEMA","source":"FDA FAERS","actionTaken":"225 reports"},{"date":"","signal":"INTRAOCULAR PRESSURE INCREASED","source":"FDA FAERS","actionTaken":"200 reports"},{"date":"","signal":"PRODUCT DOSE OMISSION ISSUE","source":"FDA FAERS","actionTaken":"200 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"192 reports"},{"date":"","signal":"CONDITION AGGRAVATED","source":"FDA FAERS","actionTaken":"164 reports"},{"date":"","signal":"DEVICE DISLOCATION","source":"FDA FAERS","actionTaken":"152 reports"},{"date":"","signal":"DEVICE FAILURE","source":"FDA FAERS","actionTaken":"150 reports"}],"commonSideEffects":[{"effect":"Skin atrophy","drugRate":"reported","severity":"unknown"},{"effect":"Miliaria","drugRate":"reported","severity":"unknown"},{"effect":"Hypopigmentation","drugRate":"reported","severity":"unknown"},{"effect":"Acneiform eruptions","drugRate":"reported","severity":"unknown"},{"effect":"Striae","drugRate":"reported","severity":"unknown"},{"effect":"Hypertrichosis","drugRate":"reported","severity":"unknown"},{"effect":"Folliculitis","drugRate":"reported","severity":"unknown"},{"effect":"Secondary infection","drugRate":"reported","severity":"unknown"},{"effect":"Dryness","drugRate":"reported","severity":"unknown"},{"effect":"Maceration of the skin","drugRate":"reported","severity":"unknown"},{"effect":"Irritation","drugRate":"reported","severity":"unknown"},{"effect":"Allergic contact dermatitis","drugRate":"reported","severity":"unknown"},{"effect":"Itching","drugRate":"reported","severity":"unknown"},{"effect":"Perioral dermatitis","drugRate":"reported","severity":"unknown"},{"effect":"Burning","drugRate":"reported","severity":"unknown"}],"contraindications":["Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of the preparation."],"specialPopulations":{"Lactation":"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 a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.","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","Paediatric use":"Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalmic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalmic-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, and decreased or interrupted growth of the gonads, but no long-term consequences of these effects have been reported."}},"trials":[],"aliases":[],"company":"Eurofarma","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.2100/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$76","description":"FLUOCINOLONE 0.01% BODY OIL","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=FLUOCINOLONE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:09:35.263466+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:09:42.692818+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:09:33.852070+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FLUOCINOLONE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:09:43.478664+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":"2026-04-20T00:09:32.813060+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:09:32.813110+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label 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production of pro-inflammatory cytokines and mediators, leading to a decrease in inflammation and immune response in the skin."},"commercial":{"launchDate":"2016","_launchSource":"OpenFDA (20160425, RISING)"},"references":[{"id":1,"url":"https://api.fda.gov/drug/label.json?search=openfda.generic_name:\"FLUOCINOLONE\"","fields":["mechanism","indications","adverse_reactions","contraindications","warnings","dosage"],"source":"OpenFDA Label"},{"id":2,"url":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:\"FLUOCINOLONE\"","fields":["approvals","company"],"source":"OpenFDA 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