Is Paracetamol registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 57 valid registrations of Paracetamol, including ADOL (500 mg, Suppository, SAR 74.00); ADOL (250 mg, Suppository, SAR 61.00); ADOL (125 mg, Suppository, SAR 49.00); ADOL 125 MG RECTAL SUPPOSITORIES (125 mg, Suppository, SAR 4.90); ADOL 250 MG RECTAL SUUPPOSITORIES (250 mg, Suppository, SAR 6.10).

Is Paracetamol approved by the US FDA?

Drugs@FDA lists 42 application product lines for Paracetamol, including ACETAMINOPHEN (Over-the-counter); INFANTS' FEVERALL (Over-the-counter); ACETAMINOPHEN (Over-the-counter); ACETAMINOPHEN (Over-the-counter); TYLENOL (Over-the-counter).

Is Paracetamol on the WHO Model List of Essential Medicines?

Yes — 5.1.5.1. Medicines for acute migraine attacks (core list): Migraine.

Are there safety signals or safety updates for Paracetamol?

EMA PRAC: 15 entries; US FDA: 10 entries; MHRA: 2 entries (latest 2025-12-22).

Active substance

Paracetamol

SFDA 107
US FDA 42
Health Canada 73
US price lines 16
NHS prices 25
WHO EML 2
Safety 27

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ADOL	500 mg	Suppository · Rectal use	100 Blister	SAR 74.00	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
ADOL	250 mg	Suppository · Rectal use	100 Blister	SAR 61.00	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
ADOL	125 mg	Suppository · Rectal use	100 Blister	SAR 49.00	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
ADOL 125 MG RECTAL SUPPOSITORIES	125 mg	Suppository · Rectal use	10 Blister	SAR 4.90	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
ADOL 250 MG RECTAL SUUPPOSITORIES	250 mg	Suppository · Rectal use	10 Blister	SAR 6.10	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
ADOL 500 MG CAPLET	500 mg	Tablet · Oral use	48 Blister	SAR 10.10	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
ADOL 500 MG CAPLET	500 mg	Tablet · Oral use	96 Blister	SAR 20.20	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
ADOL 500 MG RECTAL SUPPOSITORIES	500 mg	Suppository · Rectal use	10 Blister	SAR 7.40	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
ADOL 500MG CAPLET	500 mg	Caplet · Oral use	24 Blister	SAR 5.05	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
ADOL DROPS 100MG-ML	100 mg/ml	Drops · Oral use	1 Bottle	SAR 7.50	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
ADOL SYRUP 120MG-5ML	24 mg/ml	Syrup · Oral use	1 Bottle	SAR 5.80	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
Cetal	24 mg/ml	Syrup · Oral use	1 Bottle	SAR 3.50	Generic · OTC	Egyptian International Pharmaceutical Industries Company (EIPICO)	Valid
Cetal	120 mg	Suppository · Rectal use	5 Strip	SAR 2.45	Generic · OTC	Egyptian International Pharmaceutical Industries Company (EIPICO)	Valid
DEFADOL 160MG-5ML SUGAR FREE SYRUP	32 mg/ml	Syrup · Oral use	1 Bottle	SAR 5.90	Generic · OTC	DEEF PHARMACEUTICAL INDUSTRIES	Valid
DEFADOL 160MG-5ML SUGAR FREE SYRUP	32 mg/ml	Syrup · Oral use	1 Bottle	SAR 4.15	Generic · OTC	DEEF PHARMACEUTICAL INDUSTRIES	Valid
DEFADOL 160MG-5ML SUGAR FREE SYRUP	32 mg/ml	Syrup · Oral use	1 Bottle	SAR 10.05	Generic · OTC	DEEF PHARMACEUTICAL INDUSTRIES	Valid
EMIDOL 120MG-5ML SUSPENSION	24 mg/ml	Suspension · Oral use	1 Bottle	SAR 6.00	Generic · OTC	GLOBAL PHARMA	Valid
EMIDOL 500MG TABLET	500 mg	Tablet · Oral use	24 Blister	SAR 3.45	Generic · OTC	GLOBAL PHARMA	Valid
FEVADOL 100MG SUPPOSITORY	100 mg	Suppository · Rectal use	10 Blister	SAR 7.95	Generic · OTC	SPIMACO ADDWAEIH	Valid
FEVADOL 200MG SUPPOSITORY	200 mg	Suppository · Rectal use	10 Blister	SAR 8.90	Generic · OTC	SPIMACO ADDWAEIH	Valid
FEVADOL 350MG SUPPOSITORY	350 mg	Suppository · Rectal use	10 Blister	SAR 10.15	Generic · OTC	SPIMACO ADDWAEIH	Valid
FEVADOL 500MG TAB	500 mg	Tablet · Oral use	30 Blister	SAR 6.30	Generic · OTC	SPIMACO ADDWAEIH	Valid
FEVADOL SF 120MG\5ML SYRUP	24 mg/ml	Syrup · Oral use	1 Bottle	SAR 5.80	Generic · OTC	SPIMACO ADDWAEIH	Valid
FEVADOL SYRUP 160MG-5ML SUGAR FREE	32 mg/ml	Syrup · Oral use	1 Bottle	SAR 10.05	Generic · OTC	SPIMACO ADDWAEIH	Valid
FEVADOL SYRUP 160MG-5ML SUGAR FREE	32 mg/ml	Syrup · Oral use	1 Bottle	SAR 5.90	Generic · OTC	SPIMACO ADDWAEIH	Valid

82 more — full table

Indications — CHI Daman Drug Formulary

ACUTE PANCREATITIS-PAIN MANAGEMENT; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; BURN MANAGEMENT; CHRONIC PANCREATITIS; DENTAL ABSCESS-DENTAL PAIN; ENDOMETRIOSIS; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; FIBROMYALGIA; HYPERTHYROIDISM; INFECTIOUS MONONUCLEOSIS; INFLUENZA-SYMPTOMATIC TREATMENT; LOW BACK PAIN; MIGRAINE/ HEADACHE; MUCOSAL ULCERATION-SUPPORTIVE AGENTS; NECROTIZING PERIODONTITIS AND NECROTIZING ULCERATIVE GINGIVITIS; OSTEOARTHRITIS; OTITIS EXTERNA; OTITIS MEDIA; PAIN MANAGEMENT IN CANCER PATIENTS; PERICORONITIS; PHARYNGITIS; POSTOPERATIVE PAIN; RENAL AND URETERIC STONES; RESPIRATORY SYNCYTIAL VIRUS - SUPPORTIVE CARE; SICKLE CELL DISEASE - PAIN MANAGEMENT; SINUSITIS; THROMBOTIC THROMBOCYTOPENIC PURPURA

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

Product	Strength	Form · route	Applicant	Status	First approved
ACETAMINOPHEN	325MG; 120MG	suppository · rectal	TARO	Over-the-counter	22 Apr 1980
INFANTS' FEVERALL	80MG	suppository · rectal	TARO	Over-the-counter	22 Apr 1980
ACETAMINOPHEN	650MG	suppository · rectal	PERRIGO NEW YORK	Over-the-counter	1 Dec 1986
ACETAMINOPHEN	120MG	suppository · rectal	PERRIGO NEW YORK	Over-the-counter	6 Apr 1987
TYLENOL	650MG	tablet, extended release · oral	KENVUE BRANDS	Over-the-counter	8 Jun 1994
ACETAMINOPHEN	650MG	tablet, extended release · oral	PERRIGO	Over-the-counter	25 Feb 2000
ACETAMINOPHEN	650MG	tablet, extended release · oral	OHM LABS	Over-the-counter	19 Mar 2002
ACETAMINOPHEN	1GM/100ML (10MG/ML)	solution · intravenous	FRESENIUS KABI USA	Prescription	28 Oct 2015
ACETAMINOPHEN	1GM/100ML (10MG/ML)	solution · intravenous	SANDOZ	Prescription	22 Mar 2016
ACETAMINOPHEN	1GM/100ML (10MG/ML)	solution · intravenous	HIKMA PHARMS	Prescription	13 Jun 2016
ACETAMINOPHEN	650MG	tablet, extended release · oral	AUROBINDO PHARMA	Over-the-counter	9 Nov 2016
ACETAMINOPHEN	650MG	tablet, extended release · oral	GRANULES	Over-the-counter	16 Apr 2019
ACETAMINOPHEN	1GM/100ML (10MG/ML)	solution · intravenous	MYLAN	Prescription	7 Aug 2020
ACETAMINOPHEN	1GM/100ML (10MG/ML)	solution · intravenous	EUGIA PHARMA	Prescription	21 Oct 2020
ACETAMINOPHEN	500MG/50ML (10MG/ML); 1GM/100ML (10MG/ML)	solution · intravenous	B BRAUN MEDICAL	Prescription	18 Feb 2021
ACETAMINOPHEN	650MG	tablet, extended release · oral	MARKSANS PHARMA	Over-the-counter	25 Aug 2021
ACETAMINOPHEN	1GM/100ML (10MG/ML); 650MG/65ML (10MG/ML)	solution · intravenous	BAXTER HLTHCARE CORP	Prescription	17 Sep 2021
ACETAMINOPHEN	1GM/100ML (10MG/ML)	solution · intravenous	HIKMA PHARMS	Prescription	3 Jun 2022
ACETAMINOPHEN	1GM/100ML (10MG/ML)	solution · intravenous	ASPIRO	Prescription	27 Jul 2022
ACETAMINOPHEN	1GM/100ML (10MG/ML)	solution · intravenous	APOTEX	Prescription	18 Apr 2023
ACETAMINOPHEN	1GM/100ML (10MG/ML)	solution · intravenous	INFORLIFE	Prescription	3 May 2023
ACETAMINOPHEN	500MG/50ML (10MG/ML); 1GM/100ML (10MG/ML)	solution · intravenous	GLAND	Prescription	2 Apr 2025
ACETAMINOPHEN	1GM/100ML (10MG/ML)	solution · intravenous	CAPLIN	Prescription	5 Dec 2025
NEOPAP	120MG	suppository · rectal	POLYMEDICA	Discontinued	7 Nov 1968
TYLENOL	650MG; 120MG	suppository · rectal	J AND J CONSUMER INC	Discontinued	26 May 1976

17 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACET 120	02230434	120 MG	SUPPOSITORY · RECTAL	PENDOPHARM DIVISION OF PHARMASCIENCE INC
ACET 160	02230435	160 MG	SUPPOSITORY · RECTAL	PENDOPHARM DIVISION OF PHARMASCIENCE INC
ACET 325	02230436	325 MG	SUPPOSITORY · RECTAL	PENDOPHARM DIVISION OF PHARMASCIENCE INC
ACET 650	02230437	650 MG	SUPPOSITORY · RECTAL	PENDOPHARM DIVISION OF PHARMASCIENCE INC
ACETAMINOPHEN 160 MG CHEWABLE TABLETS	02237562	160 MG	TABLET (CHEWABLE) · ORAL	LABORATOIRES TRIANON INC.
ACETAMINOPHEN 325MG TABLETS REGULAR STRENGTH	02252805	325 MG	TABLET · ORAL	CELLCHEM PHARMACEUTICALS INC.
ACETAMINOPHEN 500 MG TABLETS EXTRA STRENGTH EASY TO SWALLOW	02255251	500 MG	TABLET · ORAL	CELLCHEM PHARMACEUTICALS INC.
ACETAMINOPHEN 500MG TABLETS EXTRA STRENGTH	02252813	500 MG	TABLET · ORAL	CELLCHEM PHARMACEUTICALS INC.
ACETAMINOPHEN ARTHRITIS PAIN	02272482	650 MG	TABLET (EXTENDED-RELEASE) · ORAL	PERRIGO INTERNATIONAL
ACETAMINOPHEN CAPLETS 325 MG	01977415	325 MG	TABLET · ORAL	LABORATOIRES TRIANON INC.
ACETAMINOPHEN CAPLETS 325 MG	02362341	325 MG	TABLET · ORAL	APOTEX INC
ACETAMINOPHEN CAPLETS 500 MG	01977474	500 MG	TABLET · ORAL	LABORATOIRES TRIANON INC.
ACETAMINOPHEN CAPLETS 500 MG	02362368	500 MG	TABLET · ORAL	APOTEX INC
ACETAMINOPHEN CHEWABLE TABLETS 160 MG	01996169	160 MG	TABLET (CHEWABLE) · ORAL	LABORATOIRES TRIANON INC.
ACETAMINOPHEN CHEWABLE TABLETS 160 MG FOR CHILDREN	02017431	160 MG	TABLET (CHEWABLE) · ORAL	LABORATOIRE RIVA INC.
ACETAMINOPHEN CHEWABLE TABLETS 80 MG	01905856	80 MG	TABLET (CHEWABLE) · ORAL	LABORATOIRES TRIANON INC.
ACETAMINOPHEN CHEWABLE TABLETS 80 MG FOR CHILDREN	02017458	80 MG	TABLET (CHEWABLE) · ORAL	LABORATOIRE RIVA INC.
ACETAMINOPHEN EXTRA STRENGTH LIQUID GELS	02469928	500 MG	CAPSULE · ORAL	LABORATOIRES TRIANON INC.
ACETAMINOPHEN EXTRA STRENGTH RAPID RELEASE TABLETS	02552159	500 MG	TABLET · ORAL	GRANULES INDIA LIMITED
ACETAMINOPHEN EXTRA STRENGTH RED TABLETS	02538407	500 MG	TABLET · ORAL	GRANULES INDIA LIMITED
ACETAMINOPHEN EXTRA STRENGTH TABLETS	02525844	500 MG	TABLET · ORAL	GRANULES INDIA LIMITED
ACETAMINOPHEN INJECTION	02483343	10 MG / ML	SOLUTION · INTRAVENOUS	AVIR PHARMA INC.
ACETAMINOPHEN INJECTION	02519305	10 MG / ML	SOLUTION · INTRAVENOUS	BAXTER CORPORATION
ACETAMINOPHEN INJECTION	02535734	100 MG / 10 ML	SOLUTION · INTRAVENOUS	B. BRAUN MELSUNGEN AG
ACETAMINOPHEN INJECTION	02535742	500 MG / 50 ML	SOLUTION · INTRAVENOUS	B. BRAUN MELSUNGEN AG

48 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ACETAMINOPHEN 1,000 MG/30 ML	$0.0192	per ML	23 Sep 2026
US NADAC	ACETAMINOPHEN 160 MG/5 ML LIQ	$0.01067	per ML	23 Sep 2026
US NADAC	ACETAMINOPHEN 160 MG/5 ML LIQ	$0.02406	per ML	23 Sep 2026
US NADAC	ACETAMINOPHEN 160 MG/5 ML SOLN	$0.02406	per ML	23 Sep 2026
US NADAC	ACETAMINOPHEN 160 MG/5 ML SOLN	$0.01067	per ML	23 Sep 2026
US NADAC	ACETAMINOPHEN 325 MG GELCAP	$0.02333	per EA	23 Sep 2026
US NADAC	ACETAMINOPHEN 325 MG TABLET	$0.02333	per EA	23 Sep 2026
US NADAC	ACETAMINOPHEN 500 MG CAPLET	$0.03394	per EA	23 Sep 2026
US NADAC	ACETAMINOPHEN 500 MG GELCAP	$0.03394	per EA	23 Sep 2026
US NADAC	ACETAMINOPHEN 500 MG TABLET	$0.03394	per EA	23 Sep 2026
US NADAC	ACETAMINOPHEN 500 MG/15 ML LIQ	$0.0192	per ML	23 Sep 2026
US NADAC	ACETAMINOPHEN 650 MG SUPPOS	$0.34938	per EA	23 Sep 2026
NHS Drug Tariff	Paracetamol 120mg suppositories	£41.04	10 suppository	1 Oct 2026
NHS Drug Tariff	Paracetamol 120mg/5ml oral suspension 5ml sachets sugar free	£3.09	12 sachet	1 Oct 2026
NHS Drug Tariff	Paracetamol 120mg/5ml oral suspension 5ml sachets sugar free	£4.90	20 sachet	1 Oct 2026
NHS Drug Tariff	Paracetamol 120mg/5ml oral suspension paediatric sugar free	£1.86	100 ml	1 Oct 2026
NHS Drug Tariff	Paracetamol 125mg suppositories	£13.80	10 suppository	1 Oct 2026
NHS Drug Tariff	Paracetamol 1g effervescent tablets sugar free	£3.35	12 tablet	1 Oct 2026
NHS Drug Tariff	Paracetamol 1g effervescent tablets sugar free	£7.89	50 tablet	1 Oct 2026
NHS Drug Tariff	Paracetamol 1g suppositories	£59.50	10 suppository	1 Oct 2026
NHS Drug Tariff	Paracetamol 1g tablets	£9.20	100 tablet	1 Oct 2026
NHS Drug Tariff	Paracetamol 240mg suppositories	£66.05	10 suppository	1 Oct 2026
NHS Drug Tariff	Paracetamol 250mg orodispersible tablets sugar free	£3.44	12 tablet	1 Oct 2026
NHS Drug Tariff	Paracetamol 250mg orodispersible tablets sugar free	£5.42	24 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.

WHO WHO Model List of Essential Medicines (2025)

5.1.5.1. Medicines for acute migraine attacks · core
Migraine
Oral > Liquid: 125 mg per 5 mL (EMLc); 120 mg per 5 mL (EMLc); 250 mg per 5 mL (EMLc) | Local > Rectal > Suppository: 250 mg (EMLc) | Oral > Solid > dispersible tablet: 100 mg (EMLc); 250 mg (EMLc) | Oral > Solid > tablet: 250 mg; 325 mg; 500 mg
2.1. Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs) · core
Pain
Oral > Liquid: 125 mg per 5 mL; 120 mg per 5 mL; 250 mg per 5 mL (EMLc) | Local > Rectal > Suppository: 100 mg; 250 mg (EMLc) | Oral > Solid > dispersible tablet: 100 mg (EMLc); 250 mg (EMLc) | Oral > Solid > tablet: 250 mg; 325 mg; 500 mg

Safety signals and safety-related labeling changes

US FDA 22 Dec 2025 FIORICET W/ CODEINE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 21 Nov 2024 COMBOGESIC — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
US FDA 21 Nov 2024 COMBOGESIC IV — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
EMA PRAC 31 Oct 2024 PRAC signal: High anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis
Action for MAH: update of the product information: Yes
EMA PRAC 11 Jul 2024 PRAC signal: High anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis
Action for MAH: update of the product information: No
US FDA 15 Dec 2023 APADAZ — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 13 Feb 2023 ULTRACET — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 10 Jan 2022 ADVIL DUAL ACTION WITH ACETAMINOPHEN — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 3 Nov 2021 EXCEDRIN (MIGRAINE) — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 13 Nov 2020 ACETAMINOPHEN — safety-related labeling change
Labeling sections changed: Use in Specific Populations
EMA PRAC 15 Mar 2019 PRAC signal: Paracetamol use during pregnancy and premature ductus arteriosus closure in offspring
Action for MAH: update of the product information: No
EMA PRAC 15 Mar 2019 PRAC signal: Paracetamol use in pregnancy and child neurodevelopment and effects on the urogenital apparatus
Action for MAH: update of the product information: Yes
EMA PRAC 31 Oct 2018 PRAC signal: Maternal paracetamol use during pregnancy and premature ductus arteriosus closure in offspring
Action for MAH: update of the product information: No
EMA PRAC 31 Oct 2018 PRAC signal: Paracetamol use in pregnancy and child neurodevelopment and effects on the urogenital apparatus
Action for MAH: update of the product information: No
US FDA 18 Sep 2018 XARTEMIS XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for paracetamol →

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.