Is there a generic for Diphenhydramine hydrochloride?

Yes. The FDA Orange Book lists 89 approved generic (ANDA) applications for Diphenhydramine hydrochloride, referencing the brand BENADRYL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Diphenhydramine hydrochloride?

BENADRYL (NDA 006146, MCNEIL CONS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Diphenhydramine hydrochloride are approved?

Diphenhydramine hydrochloride is approved in the following dosage forms: capsule, elixir, injectable, syrup.

FDA Orange Book · active-ingredient family

Diphenhydramine hydrochloride

Diphenhydramine hydrochloride: 4 brands, 89 generics; first approved Jan 25, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 89 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

110

Brand (NDA) products

Originator applications

BENADRYLRLD
MCNEIL CONSNDA 006146—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
50MG/ML INJECTABLE INJECTION Discontinued —
BENADRYL PRESERVATIVE FREERLD
MCNEIL CONSNDA 009486—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued —
BENADRYL
MCNEIL CONSNDA 005845—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
12.5MG/5ML ELIXIR ORAL Discontinued —
25MG CAPSULE ORAL Discontinued —
BENYLIN
PARKE DAVISNDA 006514—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML SYRUP ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	CAPSULE	ORAL	Discontinued	—
12.5MG/5ML	ELIXIR	ORAL	Discontinued	—
25MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	SYRUP	ORAL	Discontinued	—

Generic (ANDA) products (89)

Abbreviated applications

DIPHENHYDRAMINE HYDROCHLORIDE
ANNORA PHARMAANDA 2194702026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Rx AA
DIPHENHYDRAMINE HYDROCHLORIDE
AVET LIFESCIENCESANDA 2053372025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Rx AP
DIPHENHYDRAMINE HYDROCHLORIDE
MICRO LABSANDA 2198452025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Rx AP
DIPHENHYDRAMINE HYDROCHLORIDE
AVET LIFESCIENCESANDA 2053362025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Rx AP
DIPHENHYDRAMINE HYDROCHLORIDE
GLANDANDA 2184482024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Rx AP
DIPHENHYDRAMINE HYDROCHLORIDE
MICRO LABSANDA 2057232018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Rx AP
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
FRESENIUS KABI USAANDA 0915262013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Rx AP
DIPHENHYDRAMINE HYDROCHLORIDERS
PHARMOBEDIENTANDA 0404982005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Rx AP
DIPHENHYDRAMINE HYDROCHLORIDE
APP PHARMSANDA 0404662002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Rx AP
DIPHENHYDRAMINE HYDROCHLORIDE
HOSPIRAANDA 0401401998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
CUMBERLAND SWANANDA 0736111992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML SYRUP ORAL Discontinued —
SILPHEN
LANNETT CO INCANDA 0726461992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML SYRUP ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
SCIEGEN PHARMSANDA 0724161990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML SYRUP ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
ALPHARMA US PHARMSANDA 0704971989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML SYRUP ORAL Discontinued —
ANTITUSSIVE
PERRIGOANDA 0712921987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML SYRUP ORAL Discontinued —
VICKS FORMULA 44
WARNER CHILCOTTANDA 0705241987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML SYRUP ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
SUN PHARM INDUSTRIESANDA 0894881987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
SUN PHARM INDUSTRIESANDA 0894891987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
BELDIN
HALSEYANDA 0891791986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML SYRUP ORAL Discontinued —
HYDRAMINE
ALPHARMA US PHARMSANDA 0702051986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML SYRUP ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
PIONEER PHARMSANDA 0891011985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
PIONEER PHARMSANDA 0888801985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHEN
MORTON GROVEANDA 0701181985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML SYRUP ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
NASKAANDA 0886801985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
SUPERPHARMANDA 0890401985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
SUPERPHARMANDA 0890411985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
HALSEYANDA 0879141984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIBENIL
CENCIANDA 0883041983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
BELIX
HALSEYANDA 0865861983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
LNKANDA 0879771983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
LNKANDA 0879781983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
CENCIANDA 0879411982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
VANGARDANDA 0880341982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDERLDRS
PHARM ASSOCANDA 0875131982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Rx AA
DIPHENHYDRAMINE HYDROCHLORIDE
PUREPAC PHARMANDA 0832371982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
ALRAANDA 080519—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
ANABOLICANDA 083275—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
ELKINS SINNANDA 085701—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
FOSUN PHARMAANDA 080832—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
FOSUN PHARMAANDA 080845—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
HEATHERANDA 084524—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
HEATHERANDA 083953—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
HERITAGE PHARMAANDA 080727—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
HERITAGE PHARMAANDA 080738—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
HIKMA INTL PHARMSANDA 083567—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
IMPAX LABSANDA 080807—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
IVAX SUB TEVA PHARMSANDA 080762—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
LANNETTANDA 080868—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
LEDERLEANDA 086874—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
LEDERLEANDA 086875—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
MK LABSANDA 083087—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
MUTUAL PHARMANDA 084506—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
NEWTRON PHARMSANDA 086543—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
NEWTRON PHARMSANDA 086544—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
NEXGEN PHARMA INCANDA 083634—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
PERRIGOANDA 083061—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
PUREPAC PHARMANDA 085156—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
PUREPAC PHARMANDA 085150—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
PVT FORMANDA 083027—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
ROXANEANDA 080635—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
TEVAANDA 085874—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
VALEANT PHARM INTLANDA 080596—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
VALEANT PHARM INTLANDA 080592—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
VANGARDANDA 087630—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
WATSON LABSANDA 080728—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
WATSON LABSANDA 083797—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
WATSON LABSANDA 085138—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
WATSON LABSANDA 085083—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
WHITEWORTH TOWN PLSNANDA 083441—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MG CAPSULE ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
WHITEWORTH TOWN PLSNANDA 080800—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG CAPSULE ORAL Discontinued —
DIPHEN
USL PHARMAANDA 084640—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
BUNDYANDA 083674—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
KV PHARMANDA 085621—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
LANNETTANDA 080939—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
LEDERLEANDA 086937—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
MK LABSANDA 083088—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
PERRIGOANDA 083063—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
PVT FORMANDA 085287—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
ROXANEANDA 080643—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
HYDRAMINE
ALPHARMA US PHARMSANDA 080763—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
12.5MG/5ML ELIXIR ORAL Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
BEL MARANDA 080822—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	ELIXIR	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	SYRUP	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	SYRUP	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	SYRUP	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	SYRUP	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	SYRUP	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	SYRUP	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	SYRUP	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	SYRUP	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	SYRUP	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	ELIXIR	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	ELIXIR	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	ELIXIR	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	ELIXIR	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	ELIXIR	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
12.5MG/5ML	ELIXIR	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	CAPSULE	ORAL	Discontinued	—
25MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE	ORAL	Discontinued	—
50MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE	ORAL	Discontinued	—
50MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	CAPSULE	ORAL	Discontinued	—
25MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
50MG	CAPSULE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MG	CAPSULE	ORAL	Discontinued	—
50MG	CAPSULE	ORAL	Discontinued	—

DIPHENHYDRAMINE HYDROCHLORIDE

DR REDDYSANDA 080873—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	—
50MG/ML	INJECTABLE	INJECTION	Discontinued	—
50MG/ML	INJECTABLE	INJECTION	Discontinued	—

DIPHENHYDRAMINE HYDROCHLORIDE
HIKMAANDA 083183—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
LYPHOMEDANDA 087066—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE
WATSON LABSANDA 083533—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDERLDRS
WEST-WARD PHARMS INTANDA 080817—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Rx AP
DIPHENHYDRAMINE HYDROCHLORIDE
WYETH AYERSTANDA 080577—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
ABRAXIS PHARMANDA 080586—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued —
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
INTL MEDICATIONANDA 084094—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
50MG/ML INJECTABLE INJECTION Discontinued —

Listed patents

Orange Book patent file

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.

Approval history

FDA approval span

First approval

Jan 25, 1982

45 yr 2 mo ago

Most recent approval

Jun 17, 2026

2 mo ago

Approvals span 1982–2026 across 93 FDA applications.

Brand (NDA) 44%

Generic (ANDA) 8996%

Diphenhydramine hydrochloride: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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