Clotrimazole

Treats fungal otitis externa (otomycosis) due to Aspergillus species and Candida species. Sold as Lotrimin, Gyne-Lotrimin, Mycelex, Mycelex-7, Mycelex-G and 7 more. Every FDA application for this active ingredient: 21 branded and 14 generic.

As of Nov 15, 2026, FDA lists 35 applications for Clotrimazole (sold as Lotrimin, Gyne-Lotrimin, Mycelex and others), first approved Feb 3, 1975, with 15 new uses approved and 0 published complete response letters.

First approved: Feb 3, 1975
Applications: 35
New uses approved: 15
Complete response letters: 0
Medicare spending, 2025: $24.4M
Orphan exclusivity until: Sep 26, 2032

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Clotrimazole	Part D	$24.4M	+11%	626,367

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

CLOTRIMAZOLE 1% SOLUTION: $0.419 per MLGeneric · -22% in a year
CLOTRIMAZOLE 1% TOPICAL CREAM: $0.167 per GMGeneric · -21% in a year
CLOTRIMAZOLE 10 MG LOZENGE: $0.304 per unitGeneric · -10% in a year
CLOTRIMAZOLE 10 MG TROCHE: $0.304 per unitGeneric · -10% in a year

Orphan Designations (FDA)

4 designations, 1 approved for the designated use; see all orphan designations

Treatment of fungal otitis externa (otomycosis)Laboratorios Salvat, S.A. · designated May 10, 2016 · approved Sep 26, 2025 · exclusive to Sep 26, 2032
Treatment of Huntington's diseaseEnVivo Pharmaceuticals, Inc. · designated Mar 13, 2006
Topical treatment of children and adults with pouchitisAesRx, LLC · designated Jun 14, 2005
Treatment of sickle cell disease.Brugnara, Carlo M.D. · designated Apr 24, 1995

Clinical Trials

23 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


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

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Feb 3, 1975	LotriminNDA 17613 · New molecular entity	Schering Plough	26	Discontinued
Mar 18, 1975	LotriminNDA 17619 · New dosage form	Schering Plough	34	Discontinued
Mar 24, 1976	Gyne-LotriminNDA 17717	Bayer Healthcare LLC	19	Discontinued
Nov 8, 1978	Gyne-LotriminNDA 18052 · New dosage form	Bayer Healthcare LLC	28	Discontinued
Jan 15, 1979	MycelexNDA 18181 · New formulation or manufacturer	Bayer Hlthcare	7	Marketed
Jan 15, 1979	MycelexNDA 18183 · New formulation or manufacturer	Bayer Healthcare LLC	14	Discontinued
Feb 16, 1979	Mycelex-7NDA 18230 · New formulation or manufacturer	Bayer Healthcare LLC	15	Discontinued
Feb 27, 1979	Mycelex-7NDA 18182 · New formulation or manufacturer	Bayer Healthcare LLC	11	Discontinued
Jun 17, 1983	MycelexNDA 18713 · New dosage form	Bayer Hlthcare	15	Discontinued
Feb 17, 1984	LotriminNDA 18813 · New dosage form	Schering	22	Discontinued
Oct 27, 1989	Lotrimin AfNDA 20888	Schering Plough	6	Marketed
Oct 27, 1989	Lotrimin AfNDA 20889	Schering Plough	5	Marketed
Oct 27, 1989	Lotrimin AfNDA 20890	Schering Plough	4	Marketed
Apr 26, 1993	Gyne-Lotrimin Combination PackNDA 20289 · New dosage form	Bayer Healthcare LLC	4	Discontinued
Jul 16, 1993	ClotrimazoleANDA 74165	Encube	24	Marketed
Aug 31, 1993	ClotrimazoleANDA 72640	Sun Pharma Canada	24	Marketed
Jun 23, 1994	Mycelex-7 Combination PackNDA 20389 · New formulation or manufacturer	Bayer Healthcare LLC	0	Discontinued
Feb 28, 1995	ClotrimazoleANDA 73306	Teva	9	Marketed
Dec 4, 1995	ClotrimazoleANDA 72641	Sun Pharma Canada	16	Marketed
Jul 29, 1996	Gyne-Lotrimin 3NDA 20525 · TYPE 8	Bayer Healthcare LLC	4	Discontinued
Jul 29, 1996	Gyne-Lotrimin 3 Combination PackNDA 20526 · TYPE 8	Bayer Healthcare LLC	7	Discontinued
Jul 29, 1996	ClotrimazoleANDA 74580	Sun Pharma Canada	4	Marketed
Feb 13, 1998	GynixANDA 73249	Teva Pharms	1	Discontinued
Nov 24, 1998	Gyne-Lotrimin 3NDA 20574 · New dosage form	Bayer Healthcare LLC	4	Discontinued
Apr 12, 2000	Trivagizole 3NDA 21143 · New dosage form	Sun Pharma Canada	7	Marketed
Jul 29, 2004	ClotrimazoleANDA 76387	Hikma	0	Marketed
Oct 28, 2005	ClotrimazoleANDA 76763	Padagis US	1	Marketed
Sep 2, 2008	ClotrimazoleANDA 78338	Fougera Pharms	0	Marketed
Aug 3, 2010	ClotrimazoleANDA 90219	Glenmark Pharms	0	Marketed
Feb 15, 2019	ClotrimazoleANDA 209815	Novitium Pharma	0	Marketed
Jul 25, 2019	ClotrimazoleANDA 212281	Tp Anda Holdings	0	Marketed
Oct 16, 2023	ClotrimazoleANDA 216569	Sciegen Pharms	0	Marketed
Feb 29, 2024	ClotrimazoleANDA 215641	Rising	0	Marketed
Sep 26, 2025	CloticNDA 217628 · New dosage form	Carwin Pharm Assoc	0	Marketed
—	Mycelex-GNDA 19069	Bayer Pharms	0	Discontinued

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