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Data updated: May 26, 2026

DARVOCET-N 100 (acetaminophen)

Pain Approved 1972-12-19
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
53
Years on Market

Details

Status
Discontinued
First Approved
1972-12-19
Routes
ORAL
Dosage Forms
TABLET

Companies

XANODYNE PHARM
Active Ingredient: ACETAMINOPHEN , PROPOXYPHENE NAPSYLATE

DARVOCET-N 100 Approval History

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Original
New Indication
New Form
Label Update
43 FDA actions from 1972 to 2009
Sep 2009 SUPPL
Label · Labeling
FDA Letter Label
Jan 2007 SUPPL
Mfg · Manufacturing (CMC)
May 2006 SUPPL
Mfg · Manufacturing (CMC)

What DARVOCET-N 100 Treats

1 FDA approvals

Originally approved for its first indication in 1972 .

  • Other (1)
📋

Clinical Trial Registry

251 trials
Trial Sponsor ID Phase Status Title
NCT04165096 results posted 3475-01C MK-3475-01C, KEYMAKER-U01C Ph 2 completed KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C)
NCT06009926 NCI-2023-06404 NCI-2023-06404, STUDY00003544 Ph 2 active not recruiting Evaluation of Broccoli Seed and Sprout Extract for Detoxification of Carcinogens in Firefighters
NCT07570173 1045-005 MK-1045-005, 2025-522267-15-00 Ph 2, Ph 3 recruiting A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
NCT05878015 23-000547 Ph 4 enrolling by invitation A Study of Intravenous Acetaminophen for Small Bowel Obstruction
NCT07567924 SIUT-ERC-2024/A-475 Ph 4 active not recruiting Comparison Between Pregabalin and Acetaminophen for the Treatment of Post-Mastectomy Pain Syndrome
NCT04221477 REGENCY results posted CA41705 2019-004034-42, 2023-503628-22-00 Ph 3 active not recruiting A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
NCT06043323 2023-0087 NCI-2023-07173 Ph 2 recruiting A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma
NCT07571252 2603555595 Ph 4 not yet recruiting Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery
NCT06762600 HRS-4729-101 Ph 1 completed A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects
NCT07525791 NN9662-8158 U1111-1328-3457 Ph 1 recruiting A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills and Emptying of the Stomach in Women Not Able to Become Pregnant With Excess Body Weight
NCT07508241 C6491010 MET097-25-106 Ph 1 recruiting A Study to Learn About the Effect of Study Medicine Called PF-08653944 on How Quickly the Stomach Empties Its Content in Healthy Adults With Overweight or Obesity
NCT07525219 IRB00146434 Ph 3 not yet recruiting Suzetrigine Frame Trial Comparing Suzetrigine and Acetaminophen
NCT03823534 28927 Ph 3 recruiting Post-Op Pain Control for Prophylactic Intramedullary Nailing.
NCT05722002 CARES HUM00215416 CER-2021C1-22398 Ph 4 recruiting Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
NCT05285813 2021-1124 NCI-2022-02215 Ph 2 active not recruiting A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure
NCT03759028 IRB# 18-001158 Ph 4 recruiting Supracondylar Post-Operative Pain Study
NCT04629248 MAJESTY WA41937 2020-003233-38, 2023-506525-11-00 Ph 3 active not recruiting A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy
NCT06214468 23-067/2026659-2 Ph 1 completed Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity
NCT06187584 results posted STUDY00000286 Ph 4 completed Supracondylar Humerus Fracture (SCHF) Post-Op Study Between Opioid and Non-Opioid Pain Management
NCT07502001 HDM1005-104 Ph 1 not yet recruiting Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin
NCT04268498 ADVANCE 20201316 2019-001645-41, 19-339 Ph 2 active not recruiting A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma
NCT03818932 results posted 123192 Ph 2, Ph 3 completed Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction
NCT03258593 results posted 170157 17-C-0157 Ph 1 completed Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)
NCT04459117 TREOCAPA C19-29 2019-004297-26 Ph 2, Ph 3 completed Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen
NCT05896228 Iber-KDd 20230227 Ph 2 recruiting Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma
NCT02858310 results posted 160154 16-C-0154 Ph 1, Ph 2 completed E7 TCR T Cells for Human Papillomavirus-Associated Cancers
NCT05597878 IRB00091354 WFBCCC 01122 Ph 2, Ph 3 suspended Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy
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
NCT07429032 20230012 Ph 1 completed The Effect of AMG 133 on Gastric Emptying
NCT06356571 SubQSA LPS18183 U1111-1298-7348 Ph 2 recruiting A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
NCT04224558 Pro00051458 Ph 1, Ph 2 recruiting Stem Cell Transplantation in Crohn's Disease
NCT06994442 OPTICOM 24-12028276 U01HD116260 Ph 3 recruiting Optimizing Pain Treatment in Children On Mechanical Ventilation
NCT03913559 INOMRD NCI-2019-01062 Ph 2 terminated Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia
NCT05488847 results posted 15592 Ph 4 active not recruiting Opioid-Free Pain Protocol After Shoulder Arthroplasty
NCT07101445 STUDY00008909 NCI-2025-03018, STUDY00008909 Ph 4 recruiting Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial
NCT05640674 results posted 52475 Ph 4 terminated Post-operative Pain Management in Children With Supracondylar Humerus Fractures
NCT04918147 results posted DAIT AIG01 UM1AI144298, NIAID CRMS ID#: 38708 Ph 2 terminated Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)
NCT01391962 results posted 110200 11-C-0200 Ph 2 completed Sunitinib or Cediranib for Alveolar Soft Part Sarcoma
NCT04681105 20472 NCI-2020-08118, 20472 Ph 1 completed Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies
NCT06997016 Baylor IRB #025-220 Ph 4 enrolling by invitation Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients
NCT02797522 results posted ARC5211001 Ph 1 terminated A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)
NCT05211336 results posted 10000516 000516-C Ph 1 active not recruiting Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System
NCT03978767 PANDA 201901202 Ph 2 completed Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial
NCT05704049 IZALCO ACT17453 U1111-1280-5090, 2023-508870-27 Ph 2 active not recruiting A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
NCT05603832 100-CIP02-P Ph 3 completed A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement
NCT04270409 EFC15992 U1111-1222-7068, 2023-507419-37 Ph 3 active not recruiting Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
NCT03997851 results posted 20190133 Ph 1, Ph 2 completed Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects
NCT05035407 results posted 10000045 000045-C Ph 1 terminated T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

Showing 50 of 251 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.

DARVOCET-N 100 FDA Label Details

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Data Sources

FDA Approval: NDA017122 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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