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Data updated: May 26, 2026

CHILDREN'S ADVIL-FLAVORED (ibuprofen)

Pain Approved 1996-06-27
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
29
Years on Market

Details

Status
Over-the-counter
First Approved
1996-06-27
Routes
ORAL
Dosage Forms
SUSPENSION

Companies

HALEON US HOLDINGS
Active Ingredient: IBUPROFEN

CHILDREN'S ADVIL-FLAVORED Approval History

1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
27 FDA actions from 1996 to 2026
May 2026 SUPPL
Label · Labeling
FDA Letter
Sep 2022 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Aug 2018 SUPPL
Label · Labeling
Label

What CHILDREN'S ADVIL-FLAVORED Treats

1 FDA approvals

Originally approved for its first indication in 1996 .

  • Other (1)
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Clinical Trial Registry

193 trials
Trial Sponsor ID Phase Status Title
NCT07571252 2603555595 Ph 4 not yet recruiting Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery
NCT07565012 DIPI-PEP AFID-OPER-PEP-2025-01 IRB Approval Number Ph 4 completed Comparative Evaluation of Diclofenac Sodium and Ibuprofen for Post-Endodontic Pain Management
NCT03759028 IRB# 18-001158 Ph 4 recruiting Supracondylar Post-Operative Pain Study
NCT06757075 H-001FC Ph 4 recruiting Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia
NCT06187584 results posted STUDY00000286 Ph 4 completed Supracondylar Humerus Fracture (SCHF) Post-Op Study Between Opioid and Non-Opioid Pain Management
NCT06671002 CARES for Kids HUM00252793 BPS-2023C1-32147 Ph 4 recruiting Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial
NCT03974932 results posted HTX-011-306 Ph 3 completed Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen
NCT03695367 results posted HTX-011-215 Ph 2 completed Phase 2 Herniorrhaphy Study for Opioid Elimination
NCT04432597 200104 20-C-0104 Ph 1, Ph 2 active not recruiting HPV Vaccine PRGN-2009 Alone or in Combination With Anti-PDL1/TGF-Beta Trap (M7824) in Subjects With HPV Associated Cancers
NCT06686862 INFLAMA 2024-513803-15-00 2024-513803-15-00 Ph 3 recruiting Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis
NCT05488847 results posted 15592 Ph 4 active not recruiting Opioid-Free Pain Protocol After Shoulder Arthroplasty
NCT05640674 results posted 52475 Ph 4 terminated Post-operative Pain Management in Children With Supracondylar Humerus Fractures
NCT04681105 20472 NCI-2020-08118, 20472 Ph 1 completed Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies
NCT05575700 PERISAFE 001CCWL2022 Ph 4 completed Safety of Ibuprofen After Major Orthopaedic Surgeries
NCT04037514 IBUPAR IBUPAR-TRIAL Ph 3 completed Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus
NCT02477007 MORPHAPAIN P130921 2015-001458-14 Ph 3 completed Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children
NCT06434233 IRB00308549 Ph 4 recruiting Opioid Use After Laparoscopic Salpingectomy
NCT03493945 results posted 180078 18-C-0078 Ph 1, Ph 2 completed Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)
NCT03055247 XCGD-MOBI 2015-002356-27 Ph 2 recruiting Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD
NCT05842044 No-PAIN 20220783 Ph 2 recruiting NSAID Use After Robotic Partial Nephrectomy
NCT02330926 MENAC MENAC-2013-05 2013-002282-19 Ph 3 completed Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy
NCT05012098 results posted 10000030 000030-C Ph 2 completed Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).
NCT03893175 832417 Ph 1 completed Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction
NCT06786650 2024-KAEK-18 Ph 4 active not recruiting Comparision of the Analgesic Effects of Intravenous Ibuprofen and Tenoxicam in Acute Migraine Attack
NCT05076110 21-003441 Ph 4 recruiting Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures
NCT03060434 Pento-LR Ph 4 active not recruiting Pentoxifylline and Lumbar Radiculopathy
NCT05750264 2/2023 ANET10-1 Ph 2 active not recruiting Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy
NCT06948513 1344913 Ph 3 completed Effect of Over-the-counter Analgesics on Postoperative Pain
NCT06061575 Management of Fever in Sepsis Ph 4 completed Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients
NCT02571543 Ibudelay 015/15 Ph 2 completed Can Ibuprofen Delay Ovulation in Natural Cycle-IVF?
NCT03648437 PAI 38/2018 Ph 1 terminated Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus
NCT03767933 No OUCH Pro00073476 Ph 2 completed Non-Steroidal or Opioid Analgesia Use for Children With Musculoskeletal Injuries
NCT03749616 Adult NSAID results posted 2009129 Ph 4 terminated Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture
NCT04879823 results posted STUDY20120036 Ph 3 terminated Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity
NCT03929640 MOPAC results posted 00010393 Ph 3 terminated Management Of Pain After Cesarean Trial
NCT04791761 results posted STUDY19040036 (Part 2) Ph 1, Ph 2 terminated Non-Opioid Pain Medications After Intracapsular Adenotonsillectomy
NCT06531707 SIL-30700-III-23(1) Ph 3 recruiting Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine
NCT04646967 REB20-1076 Ph 2 completed An Evaluation of Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision
NCT06505148 024-301 Ph 4 not yet recruiting Comparing the Difference in Pain Control in the Pediatric General Surgery Population: to Alternate or Combine Acetaminophen and Ibuprofen?
NCT06077786 20435A 2023-503987-18-00 Ph 1 completed A Trial Investigating the Pain-relieving Properties of Lu AG06474 in Healthy Adult Participants
NCT05011149 SMART-PDA 459750 Ph 3 recruiting Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT
NCT01670656 results posted P08257 2012-002449-40, MK-8175A/MK-8342B-057 Ph 2 completed A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)
NCT02668783 results posted 8342B-059 2015-004325-14 Ph 3 terminated Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring (MK-8342B) in Women With Primary Dysmenorrhea (With Optional Extension) (MK-8342B-059)
NCT02668822 results posted 8342B-060 2015-004326-34 Ph 3 terminated Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring (MK-8342B) in the Treatment of Women With Primary Dysmenorrhea (MK-8342B-060)
NCT03949478 TPS-1.0 Ph 2 recruiting Treating Postictal Symptoms Using Ibuprofen and Nifedipine
NCT02276911 13BN033 Ph 2 terminated Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery
NCT02929589 results posted FWH20160095H Ph 3 terminated Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy
NCT03571737 results posted UMCIRB 17-001594 Ph 3 completed Efficacy of Lidocaine Patch in Acute Musculoskeletal Pain in the Emergency Department
NCT03399318 results posted RSRB00067717 R01NS102176 Ph 2 completed Aggressive Antipyretics for Fever Reduction in CNS Malaria
NCT06231212 TMD ECa233 CRP6305031970 Ph 2, Ph 3 completed Efficacy of a Standardized Centella Asiatica Extract in Patients With Temporomandibular Disorder

Showing 50 of 193 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CHILDREN'S ADVIL-FLAVORED FDA Label Details

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Data Sources

FDA Approval: NDA020589 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.