Ibuprofen Sodium

Sold as Advil. Every FDA application for this active ingredient: 1 branded and 1 generic.

As of Nov 15, 2026, FDA lists 2 applications for Ibuprofen Sodium (sold as Advil), first approved Jun 12, 2012, with 0 new uses approved and 0 published complete response letters.

First approved: Jun 12, 2012
Applications: 2
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $9K
First approved in the EU: Jul 28, 2004

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
COMBOGESIC IV	Part B	$9K	New	404

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

IBUPROFEN 100 MG/5 ML SUSP: $0.028 per MLGeneric · -11% in a year
IBUPROFEN 400 MG TABLET: $0.037 per unitGeneric · -9% in a year
IBUPROFEN 600 MG TABLET: $0.046 per unitGeneric · -2% in a year
IBUPROFEN 800 MG TABLET: $0.056 per unitGeneric · -4% in a year

FDA Drug Safety Communications

One communication since 2020 that name this drug; see all communications

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluidOct 15, 2020

Approvals in the EU (EMA)

First approved in the EU 94 months before the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Vlustozik (previously Ibuprofen Gen.Orph), genericGen.Orph · Feb 16, 2024
Pedea, new substanceRecordati Rare Diseases · Jul 28, 2004

Clinical Trials

144 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effects of Hypoxia or Caffeine on 4km Time-trial Morning Cycling.Caffeine, Hypoxia · Liverpool John Moores University	Phase 4	Recruiting	Nov 13, 2026
Physical Therapy for the Management of Postoperative Pain After Minimally Invasive Thoracic SurgeryPost Operative Pain · University of Miami	Phase 4	Not yet recruiting	Nov 12, 2026
Effect of S-Ibuprofen Gel on Pain in Acute Soft Tissue ContusionsAcute Pain Due to Trauma · Aponia Laboratories, Inc.	Phase 3	Recruiting	Nov 12, 2026
Pollution, Isotonic Nasal Wash, NSAID EvaluationThis Study Will Evaluate the Effects of Woodsmoke Exposures and Advil in Healthy Adults · University of British Columbia	Phase 4	Not yet recruiting	Nov 9, 2026
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot StudyTooth Loss and Rehabillitation, Dental Implant Failure · University of Medicine and Pharmacy at Ho Chi Minh City	Not applicable	Not yet recruiting	Nov 5, 2026
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia RepairInguinal Hernia, Postoperative Pain · Beni-Suef University	Not applicable	Not yet recruiting	Nov 4, 2026
Management of Breast Fibroadenoma: Comparing Observation, Microwave Ablation, and Surgical ExcisionFibroadenoma, Breast Fibroadenoma · Sohag University	Not applicable	Not yet recruiting	Oct 22, 2026
Comparison of the Effectiveness of Midpoint Transverse Process to Pleura (MTP) Block and Erector Spinae Plane (ESP) Block in Video-Assisted Thoracoscopic Surgery (VATS) at RS NgoerahPain, Postoperative Pain · Udayana University	Not applicable	Recruiting	Oct 9, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jun 12, 2012	AdvilNDA 201803 · New active ingredient	Haleon US Holdings	9	Marketed
Aug 3, 2015	Ibuprofen SodiumANDA 206581	Perrigo R And D	1	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA