FDA — authorised 4 March 1946
- Application: NDA005845
- Marketing authorisation holder: MCNEIL CONS
- Local brand name: BENADRYL
- Indication: ELIXIR — ORAL
- Status: approved
🇺🇸 Benadryl in United States
FDA authorised Benadryl on 4 March 1946
Marketing authorisations
FDA — authorised 6 March 1947
- Application: NDA006146
- Marketing authorisation holder: MCNEIL CONS
- Local brand name: BENADRYL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 May 1972
- Application: ANDA080519
- Marketing authorisation holder: ALRA
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 August 1972
- Application: ANDA080577
- Marketing authorisation holder: WYETH AYERST
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 December 1972
- Application: ANDA080643
- Marketing authorisation holder: ROXANE
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 12 October 1973
- Application: ANDA083634
- Marketing authorisation holder: NEXGEN PHARMA INC
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 October 1973
- Application: ANDA083567
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 January 1974
- Application: ANDA080592
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 December 1974
- Application: ANDA084506
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 March 1976
- Application: ANDA084094
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 June 1976
- Application: ANDA085083
- Marketing authorisation holder: WATSON LABS
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 July 1976
- Application: ANDA085138
- Marketing authorisation holder: WATSON LABS
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 September 1977
- Application: ANDA085621
- Marketing authorisation holder: KV PHARM
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 8 February 1979
- Application: ANDA086544
- Marketing authorisation holder: NEWTRON PHARMS
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 February 1979
- Application: ANDA086543
- Marketing authorisation holder: NEWTRON PHARMS
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 February 1979
- Application: ANDA084640
- Marketing authorisation holder: USL PHARMA
- Local brand name: DIPHEN
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 30 October 1979
- Application: ANDA085874
- Marketing authorisation holder: TEVA
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 March 1981
- Application: ANDA087066
- Marketing authorisation holder: LYPHOMED
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 December 1981
- Application: ANDA087630
- Marketing authorisation holder: VANGARD
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 February 1982
- Application: ANDA087513
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 27 October 1982
- Application: ANDA088034
- Marketing authorisation holder: VANGARD
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 January 1983
- Application: ANDA087978
- Marketing authorisation holder: LNK
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 January 1983
- Application: ANDA087977
- Marketing authorisation holder: LNK
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 October 1983
- Application: ANDA086586
- Marketing authorisation holder: HALSEY
- Local brand name: BELIX
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 3 January 1985
- Application: ANDA083441
- Marketing authorisation holder: WHITEWORTH TOWN PLSN
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 September 1991
- Application: ANDA070118
- Marketing authorisation holder: MORTON GROVE
- Local brand name: DIPHEN
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 12 July 2005
- Application: ANDA040498
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 March 2012
- Application: ANDA200888
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 March 2013
- Application: ANDA091526
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 October 2018
- Application: ANDA209726
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 January 2019
- Application: ANDA207597
- Marketing authorisation holder: P AND L
- Local brand name: NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 February 2019
- Application: ANDA210676
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 August 2019
- Application: ANDA211830
- Marketing authorisation holder: COREPHARMA
- Local brand name: NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 2020
- Application: ANDA213663
- Marketing authorisation holder: GRANULES
- Local brand name: NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083674
- Marketing authorisation holder: BUNDY
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: ELIXIR — ORAL
- Status: approved
FDA
- Application: ANDA088880
- Marketing authorisation holder: PIONEER PHARMS
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA080939
- Marketing authorisation holder: LANNETT
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: ELIXIR — ORAL
- Status: approved
FDA
- Application: ANDA083953
- Marketing authorisation holder: HEATHER
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA084524
- Marketing authorisation holder: HEATHER
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: NDA006514
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: BENYLIN
- Indication: SYRUP — ORAL
- Status: approved
FDA
- Application: ANDA072646
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: SILPHEN
- Indication: SYRUP — ORAL
- Status: approved
FDA
- Application: ANDA087941
- Marketing authorisation holder: CENCI
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: ELIXIR — ORAL
- Status: approved
FDA
- Application: ANDA083533
- Marketing authorisation holder: WATSON LABS
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088304
- Marketing authorisation holder: CENCI
- Local brand name: DIBENIL
- Indication: ELIXIR — ORAL
- Status: approved
FDA
- Application: ANDA085150
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA080586
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080596
- Marketing authorisation holder: VALEANT PHARM INTL
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA085156
- Marketing authorisation holder: PUREPAC PHARM
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA080635
- Marketing authorisation holder: ROXANE
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA073611
- Marketing authorisation holder: CUMBERLAND SWAN
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA
- Application: ANDA083027
- Marketing authorisation holder: PVT FORM
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA088680
- Marketing authorisation holder: NASKA
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: ELIXIR — ORAL
- Status: approved
FDA
- Application: ANDA085701
- Marketing authorisation holder: ELKINS SINN
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA083061
- Marketing authorisation holder: PERRIGO
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA083063
- Marketing authorisation holder: PERRIGO
- Local brand name: DIPHENHYDRAMINE HYDROCHLORIDE
- Indication: ELIXIR — ORAL
- Status: approved
Other Neuroscience approved in United States
Frequently asked questions
Is Benadryl approved in United States?
Yes. FDA authorised it on 4 March 1946; FDA authorised it on 6 March 1947; FDA authorised it on 31 May 1972.
Who is the marketing authorisation holder for Benadryl in United States?
MCNEIL CONS holds the US marketing authorisation.