Assyro AI

FDA Orange Book · active-ingredient family

Diphenhydramine hydrochloride

Diphenhydramine hydrochloride is approved as 4 brand and 88 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BENADRYL · NDA 006146

4

Brand (NDA)

88

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, elixir, injectable, syrup

ProductApplicantApplicationTEApproved
BENADRYLRLD×2MCNEIL CONSNDA 006146—Approved Prior to Jan 1, 1982
BENADRYL PRESERVATIVE FREERLDMCNEIL CONSNDA 009486—Approved Prior to Jan 1, 1982
BENADRYL×3MCNEIL CONSNDA 005845—Approved Prior to Jan 1, 1982
BENYLINPARKE DAVISNDA 006514—Approved Prior to Jan 1, 1982

Generic (ANDA) products (88)

ProductApplicantApplicationTEApproved
DIPHENHYDRAMINE HYDROCHLORIDEAVET LIFESCIENCESANDA 205337APNov 14, 2025
DIPHENHYDRAMINE HYDROCHLORIDEMICRO LABSANDA 219845APAug 22, 2025
DIPHENHYDRAMINE HYDROCHLORIDEAVET LIFESCIENCESANDA 205336APJun 24, 2025
DIPHENHYDRAMINE HYDROCHLORIDEGLANDANDA 218448APMar 20, 2024
DIPHENHYDRAMINE HYDROCHLORIDEMICRO LABSANDA 205723APAug 22, 2018
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREEFRESENIUS KABI USAANDA 091526APMar 26, 2013
DIPHENHYDRAMINE HYDROCHLORIDEPHARMOBEDIENTANDA 040498APJul 12, 2005
DIPHENHYDRAMINE HYDROCHLORIDEAPP PHARMSANDA 040466APMay 28, 2002
DIPHENHYDRAMINE HYDROCHLORIDEHOSPIRAANDA 040140—Nov 20, 1998
DIPHENHYDRAMINE HYDROCHLORIDECUMBERLAND SWANANDA 073611—Aug 20, 1992
SILPHENLANNETT CO INCANDA 072646—Feb 27, 1992
DIPHENHYDRAMINE HYDROCHLORIDESCIEGEN PHARMSANDA 072416—Sep 28, 1990
DIPHENHYDRAMINE HYDROCHLORIDEALPHARMA US PHARMSANDA 070497—Apr 25, 1989
ANTITUSSIVEPERRIGOANDA 071292—Apr 10, 1987
VICKS FORMULA 44WARNER CHILCOTTANDA 070524—Jan 14, 1987
DIPHENHYDRAMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 089488—Jan 02, 1987
DIPHENHYDRAMINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 089489—Jan 02, 1987
BELDINHALSEYANDA 089179—Jun 05, 1986
HYDRAMINEALPHARMA US PHARMSANDA 070205—Jan 28, 1986
DIPHENHYDRAMINE HYDROCHLORIDEPIONEER PHARMSANDA 089101—Dec 20, 1985
DIPHENHYDRAMINE HYDROCHLORIDEPIONEER PHARMSANDA 088880—Dec 20, 1985
DIPHENMORTON GROVEANDA 070118—Oct 01, 1985
DIPHENHYDRAMINE HYDROCHLORIDENASKAANDA 088680—May 31, 1985
DIPHENHYDRAMINE HYDROCHLORIDESUPERPHARMANDA 089040—May 15, 1985
DIPHENHYDRAMINE HYDROCHLORIDESUPERPHARMANDA 089041—May 15, 1985
DIPHENHYDRAMINE HYDROCHLORIDEHALSEYANDA 087914—Jun 04, 1984
DIBENILCENCIANDA 088304—Dec 16, 1983
BELIXHALSEYANDA 086586—Oct 03, 1983
DIPHENHYDRAMINE HYDROCHLORIDELNKANDA 087977—Jan 27, 1983
DIPHENHYDRAMINE HYDROCHLORIDELNKANDA 087978—Jan 27, 1983
DIPHENHYDRAMINE HYDROCHLORIDECENCIANDA 087941—Dec 17, 1982
DIPHENHYDRAMINE HYDROCHLORIDEVANGARDANDA 088034—Oct 27, 1982
DIPHENHYDRAMINE HYDROCHLORIDERLDPHARM ASSOCANDA 087513—Feb 10, 1982
DIPHENHYDRAMINE HYDROCHLORIDEPUREPAC PHARMANDA 083237—Jan 25, 1982
DIPHENHYDRAMINE HYDROCHLORIDE×2ALRAANDA 080519—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEANABOLICANDA 083275—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDE×2ELKINS SINNANDA 085701—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDE×2FOSUN PHARMAANDA 080832—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDE×2FOSUN PHARMAANDA 080845—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEHEATHERANDA 084524—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEHEATHERANDA 083953—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEHERITAGE PHARMAANDA 080727—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEHERITAGE PHARMAANDA 080738—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEHIKMA INTL PHARMSANDA 083567—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDE×2IMPAX LABSANDA 080807—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDE×2IVAX SUB TEVA PHARMSANDA 080762—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDE×2LANNETTANDA 080868—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDELEDERLEANDA 086874—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDELEDERLEANDA 086875—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDE×2MK LABSANDA 083087—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEMUTUAL PHARMANDA 084506—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDENEWTRON PHARMSANDA 086543—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDENEWTRON PHARMSANDA 086544—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDENEXGEN PHARMA INCANDA 083634—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDE×2PERRIGOANDA 083061—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEPUREPAC PHARMANDA 085156—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEPUREPAC PHARMANDA 085150—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDE×2PVT FORMANDA 083027—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEROXANEANDA 080635—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDE×2TEVAANDA 085874—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEVALEANT PHARM INTLANDA 080596—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEVALEANT PHARM INTLANDA 080592—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEVANGARDANDA 087630—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEWATSON LABSANDA 080728—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDE×2WATSON LABSANDA 083797—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEWATSON LABSANDA 085138—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEWATSON LABSANDA 085083—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEWHITEWORTH TOWN PLSNANDA 083441—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEWHITEWORTH TOWN PLSNANDA 080800—Approved Prior to Jan 1, 1982
DIPHENUSL PHARMAANDA 084640—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEBUNDYANDA 083674—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEKV PHARMANDA 085621—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDELANNETTANDA 080939—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDELEDERLEANDA 086937—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEMK LABSANDA 083088—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEPERRIGOANDA 083063—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEPVT FORMANDA 085287—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEROXANEANDA 080643—Approved Prior to Jan 1, 1982
HYDRAMINEALPHARMA US PHARMSANDA 080763—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEBEL MARANDA 080822—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDE×3DR REDDYSANDA 080873—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEHIKMAANDA 083183—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDELYPHOMEDANDA 087066—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEWATSON LABSANDA 083533—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDERLDWEST-WARD PHARMS INTANDA 080817APApproved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDEWYETH AYERSTANDA 080577—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREEABRAXIS PHARMANDA 080586—Approved Prior to Jan 1, 1982
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREEINTL MEDICATIONANDA 084094—Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Diphenhydramine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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