FDA — authorised 15 January 1979
- Application: NDA018181
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: MYCELEX
- Indication: SOLUTION — TOPICAL
- Status: approved
🇺🇸 Clotrimazole Troche in United States
FDA authorised Clotrimazole Troche on 15 January 1979 · 44 US adverse-event reports
Marketing authorisations
FDA — authorised 15 January 1979
- Application: NDA018183
- Marketing authorisation holder: BAYER HEALTHCARE LLC
- Local brand name: MYCELEX
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 17 June 1983
- Application: NDA018713
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: MYCELEX
- Indication: TROCHE/LOZENGE — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 44
Most-reported reactions
- Dry Mouth — 8 reports (18.18%)
- Dizziness — 5 reports (11.36%)
- Nausea — 5 reports (11.36%)
- Drug Ineffective — 4 reports (9.09%)
- Hypotension — 4 reports (9.09%)
- Muscle Spasms — 4 reports (9.09%)
- Off Label Use — 4 reports (9.09%)
- Pruritus — 4 reports (9.09%)
- Abdominal Pain — 3 reports (6.82%)
- Back Pain — 3 reports (6.82%)
Other Infectious Disease approved in United States
Frequently asked questions
Is Clotrimazole Troche approved in United States?
Yes. FDA authorised it on 15 January 1979; FDA authorised it on 15 January 1979; FDA authorised it on 17 June 1983.
Who is the marketing authorisation holder for Clotrimazole Troche in United States?
BAYER HLTHCARE holds the US marketing authorisation.