Regulatory PathRegulatory requirements compared

Active substance

Diphenhydramine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
AMYDRAMINE II SUGAR FREE SYRUP2.5 mg/mlSyrup · Oral use1 BottleSAR 7.15Generic · OTCGulf Pharmaceutical Industries (Julphar)Valid
EXYLIN SYRUP 14MG-5ML2.8 mg/mlSyrup · Oral use1 BottleSAR 7.70Generic · OTCSPIMACO ADDWAEIHValid
EZIPECT 12.5MG-5ML SYRUP2.5 mg/mlSyrup · Oral use1 BottleSAR 7.25Generic · OTCTabuk Pharmaceutical Manufacturing CompanyValid
BENADRYL ELIXIR 12.5MG-5ML2.5 mg/mlSyrup · Oral use1 BottleSAR 8.60Generic · OTCPARK-DAVISWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ACUTE COUGH; ALLERGIC CONJUCTIVITIS (AC); ANESTHESIA; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; POLYCYTHEMIA VERA - PRURITUS; RENAL TRANSPLANT; SCHIZOPHRENIA; VERTIGO - MOTION SICKNESS

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLinjectable · injectionWEST-WARD PHARMS INTPrescription27 Nov 1972
DIPHENHYDRAMINE HYDROCHLORIDE12.5MG/5MLelixir · oralPHARM ASSOCPrescription10 Feb 1982
DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLinjectable · injectionAPP PHARMSPrescription28 May 2002
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE50MG/MLinjectable · injectionFRESENIUS KABI USAPrescription26 Mar 2013
DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLinjectable · injectionMICRO LABSPrescription22 Aug 2018
DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLinjectable · injectionGLANDPrescription20 Mar 2024
DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLinjectable · injectionAVET LIFESCIENCESPrescription24 Jun 2025
DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLinjectable · injectionMICRO LABSPrescription22 Aug 2025
DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLinjectable · injectionAVET LIFESCIENCESPrescription14 Nov 2025
DIPHENHYDRAMINE HYDROCHLORIDE12.5MG/5MLelixir · oralANNORA PHARMAPrescription17 Jun 2026
BENADRYL50MG; 25MGcapsule · oralMCNEIL CONSDiscontinued4 Mar 1946
BENADRYL12.5MG/5MLelixir · oralMCNEIL CONSDiscontinued4 Mar 1946
BENADRYL10MG/ML; 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionMCNEIL CONSDiscontinued6 Mar 1947
BENADRYL PRESERVATIVE FREE50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionMCNEIL CONSDiscontinued30 Dec 1957
DIPHENHYDRAMINE HYDROCHLORIDE25MG; 50MGcapsule · oralIVAX SUB TEVA PHARMSDiscontinued9 May 1972
DIPHENHYDRAMINE HYDROCHLORIDE50MG; 25MGcapsule · oralALRADiscontinued31 May 1972
DIPHENHYDRAMINE HYDROCHLORIDE50MG/MLinjectable · injectionWYETH AYERSTDiscontinued7 Aug 1972
DIPHENHYDRAMINE HYDROCHLORIDE50MGcapsule · oralHERITAGE PHARMADiscontinued24 Aug 1972
DIPHENHYDRAMINE HYDROCHLORIDE50MGcapsule · oralHERITAGE PHARMADiscontinued27 Sep 1972
DIPHENHYDRAMINE HYDROCHLORIDE25MG; 50MGcapsule · oralFOSUN PHARMADiscontinued3 Nov 1972
DIPHENHYDRAMINE HYDROCHLORIDE12.5MG/5MLelixir · oralROXANEDiscontinued20 Dec 1972
DIPHENHYDRAMINE HYDROCHLORIDE25MG; 50MGcapsule · oralMK LABSDiscontinued12 Jan 1973
DIPHENHYDRAMINE HYDROCHLORIDE12.5MG/5MLelixir · oralMK LABSDiscontinued12 Jan 1973
DIPHENHYDRAMINE HYDROCHLORIDE25MGcapsule · oralWATSON LABSDiscontinued28 Feb 1973
DIPHENHYDRAMINE HYDROCHLORIDE50MGcapsule · oralWHITEWORTH TOWN PLSNDiscontinued13 Aug 1973

70 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ALLERGY FORMULA0222949225 MGTABLET · ORALVITA HEALTH PRODUCTS INC
ALLERGY FORMULA0246510812.5 MG / 5 MLSOLUTION · ORALLSL MEDPLUS INC
ALLERGY FORMULA CAPLETS0214172825 MGTABLET · ORALPERRIGO INTERNATIONAL
ALLERGY FORMULA CAPLETS0247971025 MGTABLET · ORALSIGMA LIFE SCIENCES INC.
ALLERGY FORMULA EXTRA STRENGTH0249094350 MGTABLET · ORALVITA HEALTH PRODUCTS INC
ALLERGY FORMULA LIQUID CAPSULES0230635225 MGCAPSULE · ORALVITA HEALTH PRODUCTS INC
ALLERNIX0209758325 MGTABLET · ORALTEVA CANADA LIMITED
ALLERNIX EXTRA STRENGTH0209757550 MGTABLET · ORALTEVA CANADA LIMITED
ANTI-ITCH CREAM022475602 %CREAM · TOPICALTARO PHARMACEUTICALS INC
BENADRYL ALLERGY0201784925 MGTABLET · ORALKENVUE CANADA INC.
BENADRYL ALLERGY LIQUID0201973612.5 MG / 5 MLSOLUTION · ORALKENVUE CANADA INC.
BENADRYL ALLERGY LIQUIGELS0230425225 MGCAPSULE · ORALKENVUE CANADA INC.
BENYLIN FOR CHILDREN COUGH NIGHT022488586.25 MG / 5 MLSOLUTION · ORALKENVUE CANADA INC.
BENYLIN SLEEP TIME0224885912.5 MG / 5 MLSOLUTION · ORALKENVUE CANADA INC.
CHILDREN'S ALLERGY FORMULA RAPID MELTS0250564912.5 MGTABLET (ORALLY-DISINTEGRATING) · ORALLSL MEDPLUS INC
CHILDREN'S BENADRYL ALLERGY LIQUID020196986.25 MG / 5 MLSOLUTION · ORALKENVUE CANADA INC.
CHILDREN'S CLEAR ALLERGY FORMULA024782426.25 MG / 5 MLSOLUTION · ORALLSL MEDPLUS INC
DIPHENHYDRAMINE HYDROCHLORIDE ELIXIR USP0229850312.5 MG / 5 MLELIXIR · ORALJAMP PHARMA CORPORATION
DIPHENHYDRAMINE HYDROCHLORIDE INJECTION USP0059661250 MG / MLLIQUID · INTRAMUSCULAR; INTRAVENOUSSANDOZ CANADA INCORPORATED
DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP0236956750 MG / MLSOLUTION · INTRAMUSCULAR; INTRAVENOUSFRESENIUS KABI CANADA LTD
DIPHENIST0221933650 MG / MLLIQUID · INTRAVENOUS; INTRAMUSCULAROMEGA LABORATORIES LIMITED
DORMIPHEN EXTRA-FORT CAPSULE0048986750 MGCAPSULE · ORALLABORATOIRE LALCO INC.
DORMIPHEN EXTRA-FORT COMPRIME0223778950 MGTABLET · ORALLABORATOIRE LALCO INC.
EXTRA STRENGTH ALLERGY FORMULA LIQUID CAPSULES0232127050 MGCAPSULE · ORALVITA HEALTH PRODUCTS INC
EXTRA STRENGTH BENADRYL ALLERGY0247014450 MGTABLET · ORALKENVUE CANADA INC.

27 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDIPHENHYDRAMINE 12.5 MG/5 ML$0.01744per ML23 Sep 2026
US NADACDIPHENHYDRAMINE 12.5 MG/5 ML$0.01921per ML23 Sep 2026
US NADACDIPHENHYDRAMINE 25 MG CAPSULE$0.05336per EA23 Sep 2026
US NADACDIPHENHYDRAMINE 25 MG TABLET$0.03697per EA23 Sep 2026
US NADACDIPHENHYDRAMINE 50 MG CAPSULE$0.02976per EA23 Sep 2026
US NADACDIPHENHYDRAMINE 50 MG/ML VIAL$0.89801per ML23 Sep 2026
US NADACDIPHENHYDRAMINE 50 MG/ML VIAL$1.0542per ML23 Sep 2026
US NADACFT SLEEP AID 25 MG TABLET$0.11579per EA23 Sep 2026
US NADACFT SLEEP AID 50 MG SOFTGEL$0.11141per EA23 Sep 2026
US NADACGNP NIGHTTIME SLEEP AID 50 MG$0.11141per EA23 Sep 2026
US NADACGNP SLEEP AID 25 MG CAPLET$0.05997per EA23 Sep 2026
US NADACGNP SLEEP AID 50 MG/30 ML LIQ$0.00864per ML23 Sep 2026
NHS Drug TariffDiphenhydramine 10mg/5ml oral solution£26.00150 ml1 Oct 2026
NHS Drug TariffDiphenhydramine 2% cream£4.8925 gram1 Oct 2026
NHS Drug TariffDiphenhydramine 25mg tablets£2.8720 tablet1 Oct 2026
NHS Drug TariffDiphenhydramine 50mg tablets£4.3620 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for diphenhydramine →

Combinations containing Diphenhydramine

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.