Data updated: May 26, 2026
CHILDREN'S ADVIL (ibuprofen)
Pain
Approved 1989-09-19
3
Indications
--
Phase 3 Trials
36
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 1989-09-19
- Routes
- ORAL
- Dosage Forms
- TABLET, CHEWABLE, SUSPENSION
CHILDREN'S ADVIL Approval History
1990
1991
1992
1993
1994
1995
1996
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
45 FDA actions from 1989 to 2026
Dec 2017 SUPPL
Label
Jul 2016 SUPPL
Mfg
Feb 2014 SUPPL
Mfg
Jun 2013 SUPPL
Mfg
Dec 2012 SUPPL
Mfg
Sep 2012 SUPPL
Mfg
Nov 2002 SUPPL
Label
Sep 2001 SUPPL
Mfg
Aug 2000 SUPPL
Label
Jul 2000 SUPPL
Mfg
Mar 2000 SUPPL
Mfg
Oct 1999 SUPPL
Mfg
Oct 1998 SUPPL
Mfg
May 1998 SUPPL
Mfg
May 1998 SUPPL
Mfg
Jan 1998 SUPPL
Label
Nov 1997 SUPPL
Mfg
Jun 1996 ORIGINAL
Update
Oct 1994 SUPPL
Mfg
Jul 1994 SUPPL
Mfg
Apr 1994 SUPPL
Mfg
Apr 1994 SUPPL
Mfg
Nov 1991 SUPPL
Mfg
Sep 1989 ORIGINAL
New Form
What CHILDREN'S ADVIL Treats
3 FDA approvalsOriginally approved for its first indication in 1989 . Covers 3 distinct patient populations.
- Other (3)
📋
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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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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 FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.