Is Ibuprofen registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 39 valid registrations of Ibuprofen, including ADVIL 200MG TAB (200 mg, Tablet, SAR 11.65); AMBAFEN 4 mg/ml solution for infusion (4 mg/ml, Solution for infusion, SAR 33.00); BRUFEN 400 MG TAB (400 mg, Coated tablet, SAR 13.60); BRUFEN TAB 600MG (600 mg, Film-coated tablet, SAR 19.55); Brofenex 5GM- 100GM CREAM (5 %, Cream, SAR 12.25).

Is Ibuprofen approved by the US FDA?

Drugs@FDA lists 225 application product lines for Ibuprofen, including ADVIL (Over-the-counter); MOTRIN IB (Over-the-counter); IBUPROFEN (Prescription); IBUPROFEN (Prescription); IBUPROFEN (Prescription).

Is Ibuprofen authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Ibuprofen: Pedea, Ibuprofen Gen.Orph.

Is Ibuprofen 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 Ibuprofen?

EMA PRAC: 5 entries; US FDA: 33 entries (latest 2026-07-22).

Active substance

Ibuprofen

SFDA 69
US FDA 225
EMA 3
Health Canada 47
US price lines 40
NHS prices 24
WHO EML 3
Safety 38

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ADVIL 200MG TAB	200 mg	Tablet · Oral use	24 Blister	SAR 11.65	Generic · OTC	GLAXOSMITHKLINE (GSK)	Valid
AMBAFEN 4 mg/ml solution for infusion	4 mg/ml	Solution for infusion · Intravenous use	1 Bottle	SAR 33.00	NCE · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
AMBAFEN 4 mg/ml solution for infusion	4 mg/ml	Solution for infusion · Intravenous use	1 Bag	SAR 33.00	NCE · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
BRUFEN 400 MG TAB	400 mg	Coated tablet · Oral use	30 Blister	SAR 13.60	NCE · OTC	Abbott Laboratories	Valid
BRUFEN TAB 600MG	600 mg	Film-coated tablet · Oral use	30 Blister	SAR 19.55	NCE · Prescription	Abbott Laboratories	Valid
Brofenex 5GM- 100GM CREAM	5 %	Cream · Topical	1 Tube	SAR 12.25	Generic · OTC	DEEF PHARMACEUTICAL INDUSTRIES	Valid
DOLGIT CREAM 50MG-G	5 %	Cream · Topical	1 Tube	SAR 12.25	NCE · OTC	DOLORGIET PHARMACEUTICALS	Valid
EMIFEN 100MG-5ML SUSPENSION	20 mg/ml	Suspension · Oral use	1 Bottle	SAR 5.80	Generic · OTC	GLOBAL PHARMA	Valid
EMIFEN 600 MG F-C TAB	600 mg	Film-coated tablet · Oral use	20 Blister	SAR 8.25	Generic · Prescription	GLOBAL PHARMA	Valid
Flamotal 600 mg	600 mg	Film-coated tablet · Oral use	20 Strip	SAR 8.25	Generic · Prescription	Future Pharmaceutical Industries	Valid
Flamotal 600 mg	600 mg	Film-coated tablet · Oral use	20 Strip	SAR 8.25	Generic · Prescription	Future Pharmaceutical Industries	Valid
I-PROFEN 400MG TABLET	400 mg	Tablet · Oral use	30 Blister	SAR 10.10	Generic · OTC	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
Ibuprofen Kabi	4 mg/ml	Solution for infusion · Intravenous use	10 Bottle	SAR 187.00	Generic · Prescription	Fresenius Kabi Polska	Valid
JAZOFEN 200 MG TAB	200 mg	Tablet · Oral use	30 Blister	SAR 6.25	Generic · OTC	Jazeera Pharmaceutical Industries (JPI)	Valid
JAZOFEN 400MG TAB	400 mg	Tablet · Oral use	30 Blister	SAR 12.65	Generic · OTC	Jazeera Pharmaceutical Industries (JPI)	Valid
MEDAFEN 100MG-5ML SUSPENSION	20 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 6.90	Generic · OTC	MEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIES	Valid
NUROFEN 100MG-5ML PAEDIATRIC SUSPENSION	20 mg/ml	Suspension · Oral use	1 Bottle	SAR 17.15	NCE · OTC	RECKITT BENCKISER HEALTHCARE INTERNATIONAL	Valid
NUROFEN 200MG TAB	200 mg	Coated tablet · Oral use	24 Blister	SAR 7.85	NCE · OTC	RECKITT BENCKISER HEALTHCARE INTERNATIONAL	Valid
NUROFEN 400 DOUBLE STRENGTH TABLET	400 mg	Coated tablet · Oral use	12 Blister	SAR 7.20	Generic · OTC	RECKITT BENCKISER PTY LTD	Valid
NUROFEN FOR CHILDREN STRAWBERRY ORAL SUSPENSION	20 mg/ml	Suspension · Oral use	1 Bottle	SAR 17.15	NCE · OTC	RECKITT BENCKISER HEALTHCARE INTERNATIONAL	Valid
OMAFEN 400 MG F.C TABLETS	400 mg	Tablet · Oral use	20 Blister	SAR 6.50	Generic · OTC	National Pharmaceutical Industries Co. (SAOG)	Valid
PEDEA 5MG/ML SOLUTION FOR INJECTION	5 mg/ml	Solution for injection · Intravenous use	4 Ampoule	SAR 1169.05	Generic · Prescription	Recordati Rare Diseases	Valid
PROF 100MG-5ML SUSP	20 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 7.20	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Valid
PROF 400 MG TAB	400 mg	Film-coated tablet · Oral use	30 Blister	SAR 13.60	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Valid
PROF 400 mg	100 mg/ml	Solution for infusion · Intravenous use	5 Vial	SAR 93.50	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid

44 more — full table

Indications — CHI Daman Drug Formulary

ACUTE COUGH; ACUTE PANCREATITIS-PAIN MANAGEMENT; ANKYLOSING SPONDYLITIS; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; BELL'S PALSY; CHRONIC PANCREATITIS; CYSTIC FIBROSIS; DENTAL ABSCESS-DENTAL PAIN; ENDOMETRIOSIS; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; EPIDERMOLYSIS BULLOSA; GOUT; INFECTIOUS MONONUCLEOSIS; INFLUENZA-SYMPTOMATIC TREATMENT; JUVENILE IDIOPATHIC ARTHRITIS (JIA); LOW BACK PAIN; MENSTRUAL DISORDERS; MIGRAINE/ HEADACHE; MUCOSAL ULCERATION-SUPPORTIVE AGENTS; NECROTIZING PERIODONTITIS AND NECROTIZING ULCERATIVE GINGIVITIS; NON-INFECTIOUS UVEITIS; OSTEOARTHRITIS; OTITIS EXTERNA; OTITIS MEDIA; PAIN MANAGEMENT IN CANCER PATIENTS; PERICORONITIS; PHARYNGITIS; POSTOPERATIVE PAIN; PSORIATIC ARTHRITIS; RENAL AND URETERIC STONES; RESPIRATORY SYNCYTIAL VIRUS - SUPPORTIVE CARE; RHEUMATOID ARITHRITIS; SICKLE CELL DISEASE - PAIN MANAGEMENT; SINUSITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
ADVIL	200MG	tablet · oral	HALEON US HOLDINGS	Over-the-counter	18 May 1984
MOTRIN IB	200MG	tablet · oral	KENVUE BRANDS	Over-the-counter	18 May 1984
IBUPROFEN	400MG	tablet · oral	CONTRACT PHARMACAL	Prescription	15 Oct 1986
IBUPROFEN	600MG; 400MG; 800MG	tablet · oral	CONTRACT PHARMACAL	Prescription	15 Oct 1986
IBUPROFEN	400MG	tablet · oral	AMNEAL PHARMS NY	Prescription	25 Nov 1986
IBUPROFEN	600MG	tablet · oral	AMNEAL PHARMS NY	Prescription	25 Nov 1986
IBUPROFEN	800MG	tablet · oral	AMNEAL PHARMS NY	Prescription	13 Oct 1987
IBUPROFEN	200MG	tablet · oral	PERRIGO	Over-the-counter	8 Dec 1987
IBUPROFEN	200MG	tablet · oral	AMNEAL PHARMS NY	Over-the-counter	23 May 1988
IBUPROFEN	200MG	tablet · oral	ADAPTIS	Over-the-counter	1 Jul 1988
IBUPROFEN	800MG	tablet · oral	CONTRACT PHARMACAL	Prescription	1 Jul 1988
IBUPROFEN	200MG	tablet · oral	MCNEIL	Over-the-counter	30 Mar 1994
ADVIL LIQUI-GELS	EQ 200MG FREE ACID AND POTASSIUM SALT	capsule · oral	HALEON US HOLDINGS	Over-the-counter	20 Apr 1995
ADVIL MIGRAINE LIQUI-GELS	EQ 200MG FREE ACID AND POTASSIUM SALT	capsule · oral	HALEON US HOLDINGS	Over-the-counter	20 Apr 1995
CHILDREN'S MOTRIN	100MG/5ML	suspension · oral	KENVUE BRANDS	Over-the-counter	16 Jun 1995
MOTRIN IB	200MG/10ML	suspension · oral	KENVUE BRANDS	Over-the-counter	16 Jun 1995
JUNIOR STRENGTH MOTRIN	100MG	tablet · oral	KENVUE BRANDS	Over-the-counter	10 Jun 1996
CHILDREN'S MOTRIN	40MG/ML	suspension/drops · oral	KENVUE BRANDS	Over-the-counter	10 Jun 1996
CHILDREN'S ADVIL	100MG/5ML	suspension · oral	HALEON US HOLDINGS	Over-the-counter	27 Jun 1996
CHILDREN'S ADVIL-FLAVORED	100MG/5ML	suspension · oral	HALEON US HOLDINGS	Over-the-counter	27 Jun 1996
JUNIOR STRENGTH ADVIL	100MG	tablet · oral	HALEON US HOLDINGS	Over-the-counter	13 Dec 1996
INFANT'S ADVIL	50MG/1.25ML	suspension/drops · oral	HALEON US HOLDINGS	Over-the-counter	30 Jan 1998
IBUPROFEN	100MG/5ML	suspension · oral	ACTAVIS MID ATLANTIC	Prescription	25 Mar 1998
IBUPROFEN	40MG/ML	suspension/drops · oral	L PERRIGO CO	Over-the-counter	16 Dec 1998
CHILDREN'S ADVIL	50MG	tablet, chewable · oral	HALEON US HOLDINGS	Over-the-counter	18 Dec 1998

200 more — full table

EMA European Union — centrally authorised medicines

Pedea Recordati Rare Diseases · Authorised · authorised 28 Jul 2004 · ATC C01EB16

Therapeutic indication (EMA)

Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.

Ibuprofen Gen.Orph Gen.Orph · Authorised · authorised 16 Feb 2024 · ATC C01EB16

Therapeutic indication (EMA)

Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age

Ibuprofen/Diphenhydramine Hydrochloride Wyeth Wyeth Consumer Healthcare · Application withdrawn

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ADVIL 12 HOUR	02443562	600 MG	TABLET (EXTENDED-RELEASE) · ORAL	HALEON CANADA ULC
ADVIL ARTHRITIS PAIN	02415623	400 MG	CAPSULE · ORAL	HALEON CANADA ULC
ADVIL CAPLETS	01933531	200 MG	TABLET · ORAL	HALEON CANADA ULC
ADVIL EXTRA STRENGTH CAPLETS	02244577	400 MG	TABLET · ORAL	HALEON CANADA ULC
ADVIL EXTRA STRENGTH LIQUI-GELS	02248231	400 MG	CAPSULE · ORAL	HALEON CANADA ULC
ADVIL LIQUI-GELS	02241769	200 MG	CAPSULE · ORAL	HALEON CANADA ULC
ADVIL MIGRAINE & HEADACHE	02560380	400 MG	CAPSULE · ORAL	HALEON CANADA ULC
ADVIL MINI-GELS	02485400	200 MG	CAPSULE · ORAL	HALEON CANADA ULC
ADVIL MUSCLE AND JOINT	02355701	400 MG	TABLET · ORAL	HALEON CANADA ULC
ADVIL PEDIATRIC DROPS	02242522	40 MG / ML	DROPS · ORAL	HALEON CANADA ULC
ADVIL TABLETS	01933558	200 MG	TABLET · ORAL	HALEON CANADA ULC
APO-IBUPROFEN	00441643	200 MG	TABLET · ORAL	APOTEX INC
APO-IBUPROFEN	00441651	300 MG	TABLET · ORAL	APOTEX INC
APO-IBUPROFEN	00506052	400 MG	TABLET · ORAL	APOTEX INC
APO-IBUPROFEN TAB 600MG	00585114	600 MG	TABLET · ORAL	APOTEX INC
CHILDREN'S ADVIL	02232297	100 MG / 5 ML	SUSPENSION · ORAL	HALEON CANADA ULC
CHILDREN'S ADVIL FEVER FROM COLDS OR FLU	02328437	100 MG / 5 ML	SUSPENSION · ORAL	HALEON CANADA ULC
CHILDREN'S IBUPROFEN SUSPENSION	02280175	100 MG / 5 ML	SUSPENSION · ORAL	PERRIGO INTERNATIONAL
CHILDREN'S MOTRIN	02242365	100 MG / 5 ML	SUSPENSION · ORAL	KENVUE CANADA INC.
EXTRA STRENGTH IBUPROFEN	02314770	400 MG	TABLET · ORAL	PHARMASCIENCE INC
EXTRA STRENGTH IBUPROFEN LIQUID CAPSULES	02357283	400 MG	CAPSULE · ORAL	VITA HEALTH PRODUCTS INC
EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES	02376601	400 MG	CAPSULE · ORAL	APOTEX INC
IBUPROFEN	02439689	200 MG	TABLET · ORAL	APOTEX INC
IBUPROFEN 200 MG	02257912	200 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
IBUPROFEN 400 MG	02317338	400 MG	TABLET · ORAL	JAMP PHARMA CORPORATION

22 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CHILDREN IBUPROFEN 100 MG/5 ML	$0.02367	per ML	23 Sep 2026
US NADAC	CHILDREN IBUPROFEN 100 MG/5 ML	$0.03013	per ML	23 Sep 2026
US NADAC	CHILDREN IBUPROFEN 100 MG/5 ML	$0.03324	per ML	23 Sep 2026
US NADAC	CHILDREN IBUPROFEN 100 MG/5 ML	$0.03197	per ML	23 Sep 2026
US NADAC	FT CHILD IBUPROFEN 100 MG/5 ML	$0.03324	per ML	23 Sep 2026
US NADAC	FT CHILD IBUPROFEN 100 MG/5 ML	$0.03197	per ML	23 Sep 2026
US NADAC	FT IBUPROFEN 200 MG CAPLET	$0.03314	per EA	23 Sep 2026
US NADAC	FT IBUPROFEN 200 MG LIQUID GEL	$0.07623	per EA	23 Sep 2026
US NADAC	FT IBUPROFEN 200 MG MINI SFGL	$0.07623	per EA	23 Sep 2026
US NADAC	FT IBUPROFEN 200 MG SOFTGEL	$0.07623	per EA	23 Sep 2026
US NADAC	FT IBUPROFEN 200 MG TABLET	$0.03314	per EA	23 Sep 2026
US NADAC	GNP IBUPROFEN 100 MG CHEW TAB	$0.1544	per EA	23 Sep 2026
NHS Drug Tariff	Ibuprofen 10% gel	£5.79	100 gram	1 Oct 2026
NHS Drug Tariff	Ibuprofen 100mg chewable capsules	£3.85	12 capsule	1 Oct 2026
NHS Drug Tariff	Ibuprofen 100mg/5ml oral suspension sugar free	£1.50	100 ml	1 Oct 2026
NHS Drug Tariff	Ibuprofen 200mg capsules	£5.37	30 capsule	1 Oct 2026
NHS Drug Tariff	Ibuprofen 200mg medicated plasters	£5.17	2 plaster	1 Oct 2026
NHS Drug Tariff	Ibuprofen 200mg medicated plasters	£8.41	4 plaster	1 Oct 2026
NHS Drug Tariff	Ibuprofen 200mg orodispersible tablets sugar free	£2.90	12 tablet	1 Oct 2026
NHS Drug Tariff	Ibuprofen 200mg tablets	£0.72	24 tablet	1 Oct 2026
NHS Drug Tariff	Ibuprofen 200mg tablets	£2.52	84 tablet	1 Oct 2026
NHS Drug Tariff	Ibuprofen 200mg/5ml oral suspension sugar free	£3.49	100 ml	1 Oct 2026
NHS Drug Tariff	Ibuprofen 300mg modified-release capsules	£5.37	24 capsule	1 Oct 2026
NHS Drug Tariff	Ibuprofen 400mg capsules	£7.31	20 capsule	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: 100 mg per 5 mL (EMLc); 200 mg per 5 mL (EMLc) | Oral > Solid > tablet: 200 mg; 400 mg
22.7. Medicines administered to the neonate [c] · complementary
Patent arterial duct
Parenteral > General injections > IV: 5 mg per mL (EMLc)
2.1. Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs) · core
Pain
Oral > Liquid: 200 mg per 5 mL; 100 mg per 5 mL (EMLc) | Oral > Solid > tablet: 200 mg; 400 mg; 600 mg

Safety signals and safety-related labeling changes

US FDA 22 Jul 2026 CHILDREN'S MOTRIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 21 Nov 2024 CALDOLOR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 21 Nov 2024 DUEXIS — safety-related labeling change
Labeling sections changed: Boxed Warning; 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
US FDA 25 Oct 2023 NEOPROFEN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 23 Feb 2023 ADVIL LIQUI-GELS — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 21 Feb 2023 ADVIL PM — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 8 Feb 2022 ADVIL — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 25 Jan 2022 ADVIL MIGRAINE LIQUI-GELS — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 11 Jan 2022 ADVIL PM — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 10 Jan 2022 ADVIL DUAL ACTION WITH ACETAMINOPHEN — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 14 Dec 2021 ADVIL — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 1 Dec 2021 SINE-AID IB — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 23 Nov 2021 ADVIL ALLERGY AND CONGESTION RELIEF — safety-related labeling change
Labeling sections changed: Warnings and Precautions

All safety entries for ibuprofen →

Combinations containing Ibuprofen

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.