Regulatory PathRegulatory requirements compared

Active substances

Atropine + Diphenoxylate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
DIAXINE TABS2.5, 0.025 mgTablet · Oral use30 BlisterSAR 2.00Generic · PrescriptionHikma Pharmaceuticals PLCWithdrawn by MAH · Not Marketed
INTARD TABS. 2.5MG2.5, 0.025 mgTablet · Oral use20 BlisterSAR 6.25Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
LOMOTIL2.5, 0.025 mgTablet · Oral use20 BlisterSAR 10.35NCE · PrescriptionG.D.SEARLEWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
LOMOTIL0.025MG;2.5MGtablet · oralPFIZERPrescription15 Sep 1960
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralLANNETTPrescription21 Feb 1978
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralANI PHARMSPrescription29 Oct 1979
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLsolution · oralHIKMA PHARMSPrescription3 May 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralUNICHEMPrescription13 Nov 2018
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralLEADINGPrescription20 Feb 2020
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralSPECGX LLCPrescription6 Oct 2020
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralCHARTWELL RXPrescription21 Oct 2020
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralWINDER LABS LLCPrescription27 Jan 2021
LOMOTIL0.025MG/5ML;2.5MG/5MLsolution · oralGD SEARLE LLCDiscontinued19 Oct 1961
DI-ATRO0.025MG;2.5MGtablet · oralMD PHARMDiscontinued18 Apr 1977
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralSUN PHARM INDUSTRIESDiscontinued3 Jun 1977
LONOX0.025MG;2.5MGtablet · oralFOSUN PHARMADiscontinued7 Jun 1977
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralR AND S PHARMADiscontinued5 Jul 1977
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralQUAGENDiscontinued17 Nov 1977
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralKV PHARMDiscontinued27 Jan 1978
COLONAID0.025MG/5ML;2.5MG/5MLsolution · oralMEDPOINTE PHARM HLCDiscontinued13 Feb 1978
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralINWOOD LABSDiscontinued9 Mar 1978
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralWATSON LABSDiscontinued22 Jun 1978
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralPVT FORMDiscontinued22 Dec 1978
DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE0.025MG;2.5MGcapsule · oralSCHERER RPDiscontinued6 Apr 1981
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralPARKE DAVISDiscontinued17 Jul 1981
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralFOSUN PHARMADiscontinued28 Aug 1981
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralHIKMADiscontinued15 Mar 1982
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG;2.5MGtablet · oralUSL PHARMADiscontinued29 Mar 1982

14 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
LOMOTIL000363232.5 MG; .025 MGTABLET · ORALPFIZER CANADA ULC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDIPHENOXYLATE-ATROPINE 2.5-0.025 MG TABLET$0.13885per EA23 Sep 2026
US NADACLOMOTIL 2.5-0.025 MG TABLET$2.99096per EA23 Sep 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.