IN A CLINICAL
STUDY ALEVE® IS AS
STRONG* ON PAIN AS
HYD+APAP AND
LONGER LASTING.1

*In hours 0 to 4 of a single-dose dental study of Aleve® (440 mg) versus hydrocodone plus acetaminophen, HYD+APAP (10 mg + 650 mg).

Use as directed for minor aches and pains.

 

 

 

 

IN A
CLINICAL STUDY ALEVE® IS AS STRONG* ON PAIN AS HYD+APAP AND LONGER LASTING.1

*In hours 0 to 4 of a single-dose dental study of Aleve® (440 mg) versus hydrocodone plus acetaminophen, HYD+APAP (10 mg + 650 mg).

Use as directed for minor aches and pains.

STUDY RESULTS

STUDY RESULTS

Equals to icon represents that Aleve® is as strong pain reliever as HYD and APAP combination.
STRONG PAIN
RELIEF
Clock icon depicts that Aleve® provides 12-hours of pain relief.
LONGER
LASTING
Shield icon symbolizes that Aleve® is better tolerated than HYD+APAP combination.
BETTER
TOLERATED

ALEVE®, A NON-OPIOID OTC NSAID, WAS COMPARED WITH HYD+APAP FOR DENTAL PAIN RELIEF IN A SINGLE-CENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL, PLACEBO-CONTROLLED SINGLE-DOSE STUDY.1

  • Patients experiencing moderate or severe pain (N=221) after surgical removal of impacted third molars were randomized to receive either a single dose of Aleve® (440 mg [n=90]), HYD+APAP (10 mg + 650 mg [n=87]), or placebo (n=44)
  • The primary objective was to compare Sum of Pain Intensity Difference from 0 to 12 hours (SPID0-12) after a single oral dose
  • Secondary objectives were to compare the total pain relief (TOTPAR) over 6 and 12 hours, SPID0-6, time to onset of pain relief, time to first use of rescue medication, and duration of pain intensity at least half gone over 6 and 12 hours
  • SPID0-4 was also assessed
Finding Icon

In the study, Aleve® was as effective† as HYD+APAP at hours 0 to 4 at reducing pain intensity1

†In hours 0 to 4 of a single-dose dental study of Aleve® (440 mg), hydrocodone plus acetaminophen, HYD+APAP (10 mg + 650 mg), or placebo.1

 

Finding Icon

In the study, Aleve® was as effective† as HYD+APAP at hours 0 to 4 at reducing pain intensity1

†In hours 0 to 4 of a single-dose dental study of Aleve® (440 mg), hydrocodone plus acetaminophen, HYD+APAP (10 mg + 650 mg), or placebo.1

STUDY RESULTS

The primary endpoint was met

SPID0-12 was statistically significant for Aleve® vs HYD+APAP.

 

Key secondary endpoints also showed statistical significance compared with HYD+APAP:

  • TOTPAR (0 to 6 and 0 to 12 hours; P<0.05)
  • Median time to rescue medication (P<0.001)
  • Duration of pain at least half gone over 12 hours (P<0.001)
 

Both active treatments were significantly more effective than placebo

HYD+APAP was not statistically superior to Aleve® for any endpoint.

 

Mean pain intensity difference chart.
Rescue medication chart
Chart showcasing treatment related adverse events of Naproxen compared with placebo and HYD+APAP.

More treatment-related adverse events were reported with HYD+APAP (n=18) than Aleve® (n=1), including nausea, vomiting, and dizziness.1

The growing body of evidence offers a compelling argument for first-line use of an NSAID like Aleve®, and professional organization guidelines suggest ways of putting NSAIDs into practice.1-8 
When prescribing any product, HCPs should always consider its efficacy and safety. Before any procedure requiring pain management, HCPs should talk with patients about the benefits and risks.

CONSIDER ALEVE® FOR
FIRST-LINE TREATMENT OF
MINOR DENTAL PAIN.

SEE MULTIPLE EFFICACY STUDIES

 

CONSIDER
ALEVE® FOR
FIRST-LINE
TREATMENT
OF MINOR
DENTAL PAIN.

SEE MULTIPLE EFFICACY STUDIES
Aleve tablet

References 

  1. Cooper SA, Desjardins PJ, Bertoch T, et al. Analgesic efficacy of naproxen sodium versus hydrocodone/acetaminophen in acute postsurgical dental pain: a randomized, double-blind, placebo-controlled trial. Postgrad Med. 2021. doi:10.1080/00325481.2021.2008180

  2. Data on file.

  3. Kiersch TA, Halladay SC, Hormel PC. A single-dose, double-blind comparison of naproxen sodium, acetaminophen, and placebo in postoperative dental pain. Clin Ther. 1994;16(3):394-404.

  4. American Dental Association announces new policy to combat opioid epidemic. News release. American Dental Association. March 26, 2018. Accessed October 16, 2025. https://www.ada.org/about/press-releases/2018-archives/american-dental-association-announces-new-policy-to-combat-opioid-epidemic

  5.  American Dental Association. Statement on the use of opioids in the treatment of dental pain. October 2016. Accessed October 16, 2025. https://www.ada.org/about/governance/current-policies#substanceusedisorders  

  6. American Association of Oral and Maxillofacial Surgeons. Opioid prescribing: acute and postoperative pain management; 2025. White Paper. Accessed October 9, 2025. https://aaoms.org/wp-content/uploads/2024/03/opioid_prescribing.pdf  

  7. Brophy RH, Fillingham YA. AAOS Clinical Practice Guideline Summary: Management of osteoarthritis of the knee (non-arthroplasty). J Am Acad Orthop Surg. 2022;30(9):e721–e729. doi:10.5435/JAAOS-D-21-01233. Accessed October 16, 2025. https://journals.lww.com/jaaos/Fulltext/2022/05010/AAOS_Clinical_Practice_Guideline_Summary_.10.aspx

  8. Kolasinksi SL, Neogi T, Hochberg MC, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the management of osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2020;72(2):149–162. doi:10.1002/acr.24131.