FDA — authorised 27 November 1972
- Application: ANDA080817
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Status: approved
🇺🇸 DIPHENHYDRAMINE HYDROCHLORIDE in United States
FDA authorised DIPHENHYDRAMINE HYDROCHLORIDE on 27 November 1972 · 30,111 US adverse-event reports
Marketing authorisations
FDA — authorised 22 August 2018
- Application: ANDA205723
- Marketing authorisation holder: MICRO LABS
- Indication: Labeling
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA213663
- Marketing authorisation holder: GRANULES
- 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 22 August 2025
- Application: ANDA219845
- Marketing authorisation holder: MICRO LABS
- Status: approved
FDA — authorised 14 November 2025
- Application: ANDA205337
- Marketing authorisation holder: AVET LIFESCIENCES
- 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: 30,111
Most-reported reactions
- Fatigue — 3,700 reports (12.29%)
- Off Label Use — 3,368 reports (11.19%)
- Pain — 3,288 reports (10.92%)
- Headache — 3,246 reports (10.78%)
- Drug Ineffective — 3,043 reports (10.11%)
- Nausea — 2,984 reports (9.91%)
- Infusion Related Reaction — 2,872 reports (9.54%)
- Arthralgia — 2,836 reports (9.42%)
- Nasopharyngitis — 2,400 reports (7.97%)
- Pneumonia — 2,374 reports (7.88%)
DIPHENHYDRAMINE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is DIPHENHYDRAMINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 27 November 1972; FDA authorised it on 22 August 2018; FDA authorised it on 24 September 2020.
Who is the marketing authorisation holder for DIPHENHYDRAMINE HYDROCHLORIDE in United States?
WEST-WARD PHARMS INT holds the US marketing authorisation.