Regulatory PathRegulatory requirements compared

Active substances

Doxylamine + Pyridoxine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Xonvea10,10 mg,mgGastro-resistant tablet · Oral use30 BlisterSAR 109.10NCE · PrescriptionExeltis Healthcare S.LValid
Xonvea20,20 mg,mgProlonged-release tablet · Oral use30 BlisterSAR 218.20NCE · PrescriptionExeltis Healthcare S.LValid

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

ProductStrengthForm · routeApplicantStatusFirst approved
DICLEGIS10MG;10MGtablet, delayed release · oralDUCHESNAYPrescription8 Apr 2013
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGtablet, delayed release · oralACTAVIS LABS FL INCPrescription19 Aug 2016
BONJESTA20MG;20MGtablet, extended release · oralDUCHESNAYPrescription7 Nov 2016
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGtablet, delayed release · oralPH HEALTHPrescription6 Dec 2017
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGtablet, delayed release · oralBIONPHARMAPrescription4 Aug 2023
BENDECTIN10MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet, extended release · oralSANOFI AVENTIS USDiscontinued30 Jul 1956
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGtablet, delayed release · oralPHARMOBEDIENTDiscontinued6 Jul 2020
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE20MG;20MGtablet, extended release · oralACTAVIS LABS FL INCDiscontinued1 Mar 2022

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ALOG-DOXYLAMINE/PYRIDOXINE0255257410 MG; 10 MGTABLET (DELAYED-RELEASE) · ORALANALOG PHARMA CANADA INC.
APO-DOXYLAMINE/B60241324810 MG; 10 MGTABLET (DELAYED-RELEASE) · ORALAPOTEX INC
DICLECTIN0060912910 MG; 10 MGTABLET (DELAYED-RELEASE) · ORALDUCHESNAY INC
PMS-DOXYLAMINE-PYRIDOXINE0240618710 MG; 10 MGTABLET (DELAYED-RELEASE) · ORALPHARMASCIENCE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACBONJESTA ER 20-20 MG TABLET$11.11533per EA23 Sep 2026
US NADACDICLEGIS DR 10-10 MG TABLET$1.67584per EA23 Sep 2026
US NADACDOXYLAMINE-PYRIDOXINE 10-10 MG$1.09163per EA23 Sep 2026
NHS Drug TariffDoxylamine 10mg / Pyridoxine 10mg gastro-resistant tablets£28.5020 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.

Components

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.