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Data updated: May 26, 2026

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE (ibuprofen)

Pain Approved 2014-07-03
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Over-the-counter
First Approved
2014-07-03
Routes
ORAL
Dosage Forms
TABLET

Companies

PERRIGO R AND D
Active Ingredient: IBUPROFEN , PHENYLEPHRINE HYDROCHLORIDE

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2014 to 2014
Jul 2014 ORIGINAL
Update

What IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • 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.

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE FDA Label Details

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Data Sources

FDA Approval: ANDA203200 → Trials: ClinicalTrials.gov →

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