Is Paracetamol + Tramadol 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 Paracetamol + Tramadol, including ZALDIAR (325,37.5 mg,mg, Film-coated tablet, SAR 27.10).

Is Paracetamol + Tramadol approved by the US FDA?

Drugs@FDA lists 12 application product lines for Paracetamol + Tramadol, including TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (Prescription); TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (Prescription); TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (Prescription); TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (Prescription); TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (Prescription).

Active substances

Paracetamol + Tramadol

SFDA 2
US FDA 12
Health Canada 8
US price lines 1
NHS prices 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ZALDIAR	325,37.5 mg,mg	Film-coated tablet · Oral use	20 Blister	SAR 27.10	NCE · Prescription	STADA ARZNEIMITTEL GmbH	Valid
ZALDIAR 37.5-325MG F-C TABLETS	37.5, 325 mg	Film-coated tablet · Oral use	20 Blister	SAR 27.10	NCE · Prescription	GRUNENTHAL	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

DIABETIC NEUROPATHY; ENDOMETRIOSIS; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; FIBROMYALGIA; LOW BACK PAIN; NEUROPATHIC PAIN; PAIN MANAGEMENT IN CANCER PATIENTS; POST-HERPETIC NEURALGIA; POSTOPERATIVE PAIN; RENAL AND URETERIC STONES

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

Product	Strength	Form · route	Applicant	Status	First approved
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	tablet · oral	RISING	Prescription	26 Sep 2008
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	tablet · oral	AMNEAL PHARMS	Prescription	9 Dec 2009
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	tablet · oral	ALKEM LABS LTD	Prescription	30 Mar 2012
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	tablet · oral	ZYDUS PHARMS USA INC	Prescription	6 Sep 2012
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	tablet · oral	AUROBINDO PHARMA	Prescription	22 Mar 2017
ULTRACET	325MG;37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	JANSSEN PHARMS	Discontinued	15 Aug 2001
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	tablet · oral	CHARTWELL RX	Discontinued	21 Apr 2005
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	tablet · oral	SUN PHARM INDS INC	Discontinued	16 Dec 2005
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	tablet · oral	GRAVITI PHARMS	Discontinued	26 Jul 2006
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	tablet · oral	MICRO LABS LTD INDIA	Discontinued	14 Dec 2012
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	tablet · oral	SENORES PHARMS	Discontinued	7 Apr 2014
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	325MG;37.5MG	tablet · oral	MACLEODS PHARMS	Discontinued	2 May 2017

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-TRAMADOL/ACET	02336790	37.5 MG; 325 MG	TABLET · ORAL	APOTEX INC
AURO-TRAMADOL/ACETAMINOPHEN	02439050	325 MG; 37.5 MG	TABLET · ORAL	AURO PHARMA INC
JAMP-ACET-TRAMADOL	02388308	325 MG; 37.5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
MAR-TRAMADOL/ACET	02388324	325 MG; 37.5 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MINT-TRAMADOL/ACET	02389800	325 MG; 37.5 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
PRZ-TRAMADOL/ACET	02551047	37.5 MG; 325 MG	TABLET · ORAL	PHARMARIS CANADA INC
TARO-TRAMADOL/ACET	02388197	325 MG; 37.5 MG	TABLET · ORAL	SUN PHARMA CANADA INC
TEVA-TRAMADOL/ACETAMINOPHEN	02347180	325 MG; 37.5 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TRAMADOL-ACETAMINOPHEN 37.5-325 MG TAB	$0.11595	per EA	23 Sep 2026
NHS Drug Tariff	Tramadol 37.5mg / Paracetamol 325mg tablets	£3.32	60 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.