Treats oropharyngeal candidiasis (OPC). Sold as Monistat, Oravig. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 2 applications for Miconazole (sold as Monistat, Oravig), first approved Oct 4, 1978, with 0 new uses approved and 0 published complete response letters.
| Nanoparticle-Based Prunus Salicina Extract vs. Clotrimazole for OtomycosisOtomycosis, Antifungal Agents · Deraya University | Not applicable | Recruiting | Oct 9, 2026 |
| Citrus Sinensis Peel Gel for Radiation-Induced Oral MucositisRadiation-induced Oral Mucositis, Head and Neck Cancer · Alexandria University | Not applicable | Not yet recruiting | Sep 10, 2026 |
| Clinical, Dermoscopic, and Mycological Characteristics of Tinea Capitis in ChildrenFungal Infection by Site, Tinea Capitis · Sohag University | — | Not yet recruiting | Sep 3, 2026 |
| Clinical, Dermoscopic, and Mycological Evaluations of Resistant DermatophytosisFungal Skin Infection, Tinea Corporis · Sohag University | — | Not yet recruiting | Sep 1, 2026 |
| Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led ModelOral Lichen Planus, Recurrent Aphthous Stomatitis · University of Fujairah | Not applicable | Not yet recruiting | Jul 22, 2026 |
| Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing AgentFecal Incontinence, Urinary Incontinence · University of Alberta | Not applicable | Recruiting | Apr 13, 2026 |
| Fungal Empyema ThoracisPyothorax, Fungal Infection Lungs · University of Health Sciences Lahore | Not applicable | Recruiting | Jan 13, 2026 |
| Comparative Efficacy of Topical 1% Clotrimazole vs Oral Itraconazole in the Treatment of Pityriasis VersicolorPityriasis Versicolor · Combined Military Hospital Abbottabad | Phase 1 / Phase 2 | Not yet recruiting | Jan 12, 2026 |
| Oct 4, 1978 | MonistatNDA 18040 · New dosage form | Janssen Pharma | 6 | Discontinued |
| Apr 16, 2010 | OravigNDA 22404 · New dosage form | Galt Pharms | 3 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
