FDA — authorised 24 September 2020
- Application: ANDA213663
- Marketing authorisation holder: GRANULES
- Status: approved
🇺🇸 Benadryl in United States
FDA authorised Benadryl on 24 September 2020
Marketing authorisations
FDA — authorised 29 August 2023
- Application: ANDA205723
- Marketing authorisation holder: MICRO LABS
- Indication: Labeling
- Status: approved
FDA — authorised 20 March 2024
- Application: ANDA218448
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 24 June 2025
- Application: ANDA205336
- Marketing authorisation holder: AVET LIFESCIENCES
- Status: approved
FDA — authorised 14 November 2025
- Application: ANDA205337
- Marketing authorisation holder: AVET LIFESCIENCES
- Status: approved
Benadryl in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Benadryl approved in United States?
Yes. FDA authorised it on 24 September 2020; FDA authorised it on 29 August 2023; FDA authorised it on 20 March 2024.
Who is the marketing authorisation holder for Benadryl in United States?
GRANULES holds the US marketing authorisation.