Is Loperamide + Simeticone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Loperamide + Simeticone, including Imodium Plus Caplets (125,2 mg,mg, Tablet, SAR 25.70).

Is Loperamide + Simeticone approved by the US FDA?

Drugs@FDA lists 10 application product lines for Loperamide + Simeticone, including IMODIUM MULTI-SYMPTOM RELIEF (Over-the-counter); LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (Over-the-counter); LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (Over-the-counter); LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (Over-the-counter); LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE (Over-the-counter).

Active substances

Loperamide + Simeticone

SFDA 1
US FDA 10
Health Canada 1
NHS prices 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Imodium Plus Caplets	125,2 mg,mg	Tablet · Oral use	12 Blister	SAR 25.70	NCE · OTC	MCNEIL PRODUCTS LIMITED	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	tablet · oral	KENVUE BRANDS	Over-the-counter	30 Nov 2000
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	tablet · oral	PERRIGO R AND D	Over-the-counter	5 Sep 2018
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	tablet · oral	AUROBINDO PHARMA LTD	Over-the-counter	14 Dec 2020
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	tablet · oral	GUARDIAN DRUG	Over-the-counter	27 May 2021
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	tablet · oral	HETERO LABS LTD V	Over-the-counter	17 Jun 2021
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	tablet · oral	BIONPHARMA	Over-the-counter	10 Sep 2021
IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	tablet, chewable · oral	J AND J CONSUMER INC	Discontinued	26 Jun 1997
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	tablet, chewable · oral	PERRIGO	Discontinued	30 Aug 2002
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	tablet · oral	SUN PHARM INDS LTD	Discontinued	6 Sep 2006
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	tablet · oral	GRANULES	Discontinued	29 Aug 2022

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
IMODIUM COMPLETE	02245185	125 MG; 2 MG	TABLET · ORAL	KENVUE CANADA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Loperamide 2mg / Simeticone 125mg tablets	£3.39	6 tablet	1 Oct 2026
NHS Drug Tariff	Loperamide 2mg / Simeticone 125mg tablets	£5.94	12 tablet	1 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.