FDA — authorised 25 July 2000
- Application: NDA020941
- Marketing authorisation holder: HALEON US HOLDINGS
- Local brand name: ABREVA
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 Abreva in United States
FDA authorised Abreva on 25 July 2000 · 16,453 US adverse-event reports
Marketing authorisations
FDA — authorised 19 November 2018
- Application: ANDA208754
- Marketing authorisation holder: P AND L
- Local brand name: DOCOSANOL
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 3 May 2022
- Application: ANDA215839
- Marketing authorisation holder: ALEMBIC
- Local brand name: DOCOSANOL
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 7 October 2022
- Application: ANDA212385
- Marketing authorisation holder: P AND L DEVELOPMENT
- Local brand name: DOCOSANOL
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 26 October 2023
- Application: ANDA214454
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: DOCOSANOL
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 1 March 2024
- Application: ANDA217090
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DOCOSANOL
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 3 October 2025
- Application: ANDA214613
- Marketing authorisation holder: DR REDDYS
- Local brand name: DOCOSANOL
- Indication: CREAM — 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: 16,453
Most-reported reactions
- Drug Ineffective — 6,635 reports (40.33%)
- Oral Herpes — 2,413 reports (14.67%)
- Condition Aggravated — 1,891 reports (11.49%)
- Drug Administration Error — 1,779 reports (10.81%)
- Incorrect Drug Administration Duration — 803 reports (4.88%)
- Herpes Simplex — 706 reports (4.29%)
- Incorrect Product Administration Duration — 611 reports (3.71%)
- Lip Swelling — 540 reports (3.28%)
- Wrong Technique In Product Usage Process — 538 reports (3.27%)
- Product Quality Issue — 537 reports (3.26%)
Abreva in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Abreva approved in United States?
Yes. FDA authorised it on 25 July 2000; FDA authorised it on 19 November 2018; FDA authorised it on 3 May 2022.
Who is the marketing authorisation holder for Abreva in United States?
HALEON US HOLDINGS holds the US marketing authorisation.