FDA — authorised 17 September 1976
- Application: NDA017768
- Marketing authorisation holder: MOLNLYCKE HLTH
- Local brand name: HIBICLENS
- Indication: SOLUTION — TOPICAL
- Status: approved
🇺🇸 Hibiclens in United States
FDA authorised Hibiclens on 17 September 1976 · 257 US adverse-event reports
Marketing authorisations
FDA — authorised 27 August 1981
- Application: NDA018423
- Marketing authorisation holder: MOLNLYCKE HLTH
- Local brand name: HIBICLENS
- Indication: SPONGE — TOPICAL
- Status: approved
FDA
- 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: 20 April 2025 – 20 April 2026
- Total reports: 257
Most-reported reactions
- Pain — 45 reports (17.51%)
- Pruritus — 28 reports (10.89%)
- Anxiety — 27 reports (10.51%)
- Condition Aggravated — 24 reports (9.34%)
- Drug Hypersensitivity — 23 reports (8.95%)
- Fatigue — 23 reports (8.95%)
- Rash — 23 reports (8.95%)
- Nausea — 22 reports (8.56%)
- Chronic Kidney Disease — 21 reports (8.17%)
- Emotional Distress — 21 reports (8.17%)
Hibiclens in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Hibiclens approved in United States?
Yes. FDA authorised it on 17 September 1976; FDA authorised it on 27 August 1981; FDA has authorised it.
Who is the marketing authorisation holder for Hibiclens in United States?
MOLNLYCKE HLTH holds the US marketing authorisation.