MedPath

Acetaminophen

Generic Name
Acetaminophen
Brand Names
Acephen, Acetadryl, Allzital, Apadaz, Arthriten Inflammatory Pain, Bupap, Butapap, Cetafen, Children's Silapap, Coricidin Hbp Cold & Flu, Darvocet-N, Dayquil Sinex, Diphen, Dolofin, Dologen, Dologesic Reformulated Jun 2016, Duralgina, Dvorah, Endocet, Esgic, Exaprin, Excedrin, Excedrin PM Triple Action, Excedrin Tension Headache, Feverall, Fioricet, Fioricet With Codeine, Goody's Back & Body Pain Relief, Goody's Body Pain, Goody's Extra Strength, Goody's Headache Relief Shot, Goody's PM, Hycet, Legatrin PM, Little Fevers, Lorcet, Lortab, Mapap, Mersyndol, Midol Complete, Midol Cramps & Bodyaches, Nalocet, Norco, Orbivan, Pamprin Max Formula, Pamprin Multi-symptom, Panadol, Pediacare Children's Fever Reducer Pain Reliever, Percocet, Percogesic Reformulated Jan 2011, Pharbetol, Premsyn Pms, Prolate, Rivacocet, Robaxacet, Robaxacet-8, Roxicet, Sudafed PE Sinus Headache, Tactinal, Tencon, Trezix, Triatec, Triatec-30, Triatec-8, Tylenol, Tylenol PM, Tylenol With Codeine, Ultracet, Vanatol, Vanatol S, Vanquish, Xodol, Xolox, Zamicet, Zflex, Zydone
Drug Type
Small Molecule
Chemical Formula
C8H9NO2
CAS Number
103-90-2
Unique Ingredient Identifier
362O9ITL9D

Overview

Acetaminophen (paracetamol), also commonly known as Tylenol, is the most commonly taken analgesic worldwide and is recommended as first-line therapy in pain conditions by the World Health Organization (WHO). It is also used for its antipyretic effects, helping to reduce fever. This drug was initially approved by the U.S. FDA in 1951 and is available in a variety of forms including syrup form, regular tablets, effervescent tablets, injection, suppository, and other forms. Acetaminophen is often found combined with other drugs in more than 600 over the counter (OTC) allergy medications, cold medications, sleep medications, pain relievers, and other products. Confusion about dosing of this drug may be caused by the availability of different formulas, strengths, and dosage instructions for children of different ages. Due to the possibility of fatal overdose and liver failure associated with the incorrect use of acetaminophen, it is important to follow current and available national and manufacturer dosing guidelines while this drug is taken or prescribed.

Indication

In general, acetaminophen is used for the treatment of mild to moderate pain and reduction of fever. It is available over the counter in various forms, the most common being oral forms. Acetaminophen injection is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever. Because of its low risk of causing allergic reactions, this drug can be administered in patients who are intolerant to salicylates and those with allergic tendencies, including bronchial asthmatics. Specific dosing guidelines should be followed when administering acetaminophen to children.

Associated Conditions

  • Acute Gouty Arthritis
  • Acute Musculoskeletal Pain
  • Allergic Reaction
  • Allergy to Tree Pollen
  • Ankylosing Spondylitis (AS)
  • Chills
  • Cold
  • Common Cold
  • Cough
  • Cough caused by Common Cold
  • Coughing caused by Flu caused by Influenza
  • Dyskinesia of the Biliary Tract
  • Dyskinesia of the Urinary Tract
  • Febrile Convulsions
  • Febrile Illness Acute
  • Fever
  • Fibromyalgia
  • Flu caused by Influenza
  • Headache
  • Joint dislocations
  • Menstrual Distress (Dysmenorrhea)
  • Mild pain
  • Muscle Inflammation
  • Muscle Injuries
  • Muscle Spasms
  • Musculoskeletal Pain
  • Myalgia
  • Nasal Congestion
  • Neuropathic Pain
  • Osteoarthritis (OA)
  • Pain
  • Postoperative pain
  • Premenstrual cramps
  • Rheumatoid Arthritis
  • Rhinopharyngitis
  • Rhinorrhoea
  • Severe Pain
  • Sinusitis
  • Spasms
  • Spastic Pain of the Gastrointestinal Tract
  • Sprains
  • Symptoms Cold
  • Tension Headache
  • Toothache
  • Upper Respiratory Tract Infection
  • Whiplash Syndrome
  • Acute Torticollis
  • Articular inflammation
  • Cold or flu syndrome
  • Mild to moderate pain
  • Minor aches and pains
  • Minor pain
  • Moderate Pain
  • Moderate to severe pain

Research Report

Published: May 29, 2025

Acetaminophen: A Comprehensive Pharmacological and Clinical Review

1. Introduction to Acetaminophen

1.1. Overview and Therapeutic Class

Acetaminophen, known internationally as paracetamol, is a globally recognized non-opioid analgesic and antipyretic agent.[1] It is widely available both over-the-counter (OTC) and as a prescription medication. The World Health Organization (WHO) recommends acetaminophen as a first-line therapeutic option for the management of mild to moderate pain.[1] Its primary clinical applications are the relief of pain and the reduction of fever, establishing it as a fundamental medication in symptomatic treatment for a diverse range of conditions.[3]

1.2. Chemical Properties and Identifiers

Acetaminophen is classified pharmacologically as a Small Molecule [User Query]. For precise identification in scientific and regulatory contexts, it is assigned the Chemical Abstracts Service (CAS) Number 103-90-2 and the DrugBank Accession Number DB00316 [User Query]. These identifiers are essential for accurate referencing in research, clinical databases, and chemical inventories.

1.3. Significance in Clinical Practice

Acetaminophen is one of the most frequently used medications for pain and fever relief in both the United States and Europe.[1] Its pervasive use is highlighted by its presence as an active ingredient in over 600 different OTC and prescription medicinal products, including standalone analgesics, fever reducers, sleep aids, and various combination formulations for cough, cold, and allergy symptoms.[5] The enduring clinical significance of acetaminophen is founded on its well-established efficacy for common ailments and a generally favorable safety profile when administered according to recommended dosing guidelines. This has solidified its position as an indispensable component of household medicine cabinets worldwide.[2]

Continue reading the full research report

Clinical Trials

View More Clinical Trials

Sign in to access the complete clinical trial database with detailed study information.

FDA Drug Approvals

View More FDA Approvals

Sign in to access additional FDA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
RedPharm Drug, Inc.
67296-0355
ORAL
325 mg in 1 1
2/21/2024
Rhodes Pharmaceuticals L.P.
42858-202
ORAL
325 mg in 1 1
1/2/2024
FH2 Pharma LLC
72887-683
ORAL
300 mg in 1 1
4/27/2023
Eugia US LLC
55150-307
INTRAVENOUS
10 mg in 1 mL
8/3/2023
Eywa Pharma Inc
71930-044
ORAL
300 mg in 1 1
6/17/2019
Advanced Rx of Tennessee, LLC
80425-0528
ORAL
300 mg in 1 1
6/2/2025
Bryant Ranch Prepack
63629-1186
ORAL
300 mg in 1 1
5/20/2021
NuCare Pharmaceuticals,Inc.
68071-2856
ORAL
325 mg in 1 1
10/24/2022
Major Pharmaceuticals
0904-6826
ORAL
325 mg in 1 1
1/31/2022
Redpharm Drug
67296-0836
ORAL
325 mg in 1 1
8/28/2025

EMA Drug Approvals

View More EMA Approvals

Sign in to access additional EMA-approved drug information with detailed regulatory data.

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

View More HSA Approvals

Sign in to access additional HSA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

View More NMPA Approvals

Sign in to access additional NMPA-approved drug information with detailed regulatory data.

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

View More PPB Approvals

Sign in to access additional PPB-approved drug information with detailed regulatory data.

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

Health Canada Drug Approvals

View More Health Canada Approvals

Sign in to access additional Health Canada approved drug information with detailed regulatory data.

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ACETAMINOPHEN TAB 500MG EXT STRENGTH
pharmel inc
00718866
Tablet - Oral
500 MG
12/31/1987
ACETAB TAB 325MG
laboratoire romilo
00422061
Tablet - Oral
325 MG / TAB
4/2/1980
WAMPOLE-ACETAMINOPHEN/CODEINE/CAFFEINE
02453703
Tablet - Oral
300 MG
12/23/2016
PAIN & FEVER + DECONGESTANT
accudial pharmaceutical inc
02367262
Suspension - Oral
160 MG / 5 ML
N/A
ACETAMINOPHEN ARTHRITIS PAIN
perrigo international
02272482
Tablet (Extended-Release) - Oral
650 MG
8/28/2006
ACETAMINOPHEN TABLETS USP 500 MG
genvion corporation
02383667
Tablet - Oral
500 MG
N/A
ACETAMINOPHEN TABLETS EXTRA STRENGTH
tanta pharmaceuticals inc
01904132
Tablet - Oral
500 MG
12/31/1991
ACETAMINOPHEN ULTRA RELIEF EXTRA STRENGTH
02286807
Tablet - Oral
500 MG
N/A
ACETAMINOPHEN TABLETS 325MG
westcan pharmaceuticals ltd.
00793264
Tablet - Oral
325 MG / TAB
2/20/1997
TYLENOL COMPLETE COLD, COUGH & FLU PLUS MUCUS RELIEF
mcneil consumer healthcare division of johnson & johnson inc
02295326
Capsule - Oral
250 MG
8/18/2009

CIMA AEMPS Drug Approvals

View More CIMA AEMPS Approvals

Sign in to access additional CIMA AEMPS approved drug information with detailed regulatory data.

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
PARACETAMOL FARMALID 650 MG COMPRIMIDOS EFG
Dermogen-Farma S.A.
86643
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
PARACETAMOL ONEDOSE 1 G COMPRIMIDOS EFG
Laboratorios Bluepharma, S.L.
73492
COMPRIMIDO
Sin Receta
Not Commercialized
PARACETAMOL NORMON 10 mg/ml SOLUCION PARA PERFUSION EFG
Laboratorios Normon S.A.
71530
SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
CUPANOL NIÑOS 250 mg COMPRIMIDOS
Laboratorios Ern S.A.
56815
COMPRIMIDO
Sin Receta
Not Commercialized
PARACETAMOL SANDOZ 1 g COMPRIMIDOS EFG
Sandoz Farmaceutica S.A.
70311
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
ALERJUVENTUS EXPECTORANTE JARABE
Laboratorios Ern S.A.
46599
JARABE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
GELOGRIP POLVO PARA SOLUCION ORAL
70287
POLVO PARA SOLUCIÓN ORAL
Medicamento Sujeto A Prescripción Médica
Not Commercialized
GELOCATIL PEDIATRICO 250 mg granulado
72344
GRANULADO
Sin Receta
Not Commercialized
GRIPALNORM GRANULADO PARA SOLUCION ORAL
Laboratorios Normon S.A.
82096
GRANULADO PARA SOLUCIÓN ORAL
Medicamento Sujeto A Prescripción Médica
Commercialized
TRAMADOL/PARACETAMOL DAVUR 75 MG/650 MG COMPRIMIDOS
Laboratorios Davur, S.L.U.
83142
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized

Philippines FDA Drug Approvals

View More Philippines FDA Approvals

Sign in to access additional Philippines FDA approved drug information with detailed regulatory data.

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

View More Saudi SFDA Approvals

Sign in to access additional Saudi SFDA approved drug information with detailed regulatory data.

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

View More Malaysia NPRA Approvals

Sign in to access additional Malaysia NPRA approved drug information with detailed regulatory data.

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

View More UK EMC Drug Information

Sign in to access additional UK EMC drug information with detailed pharmaceutical data.

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.