Excedrin (Migraine Relief)

NDA 20802, held by Haleon US Holdings. Acetaminophen; Aspirin; Caffeine.

As of Nov 13, 2026, NDA 20802 (Excedrin (Migraine Relief)), held by Haleon US Holdings, was first approved by FDA on Jan 14, 1998, with 27 approved supplements and 0 published complete response letters.

First approved: Jan 14, 1998
Review: Standard
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use treats migraine

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Oct 7, 1999	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Jan 14, 1998	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Excedrin (Migraine Relief)250MG;250MG;65MG · tablet;oral	Acetaminophen; Aspirin; Caffeine	OTCReference drug

All 28 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 2, 2026	Supplement 46Labeling · Standard review	Approved	Letter Label
May 15, 2023	Supplement 42Manufacturing	Approved	Letter Label
Apr 17, 2023	Supplement 43Labeling · Standard review	Approved	Label Letter
Dec 7, 2021	Supplement 40Manufacturing	Approved	Label Letter
Nov 3, 2021	Supplement 38Labeling · Standard review	Approved	Label Letter
Feb 27, 2020	Supplement 34Labeling · Standard review	Approved	Label Letter
Apr 15, 2019	Supplement 33Labeling · Standard review	Approved	Letter Label
Jan 2, 2018	Supplement 32Labeling · Standard review	Approved	Label Letter
Oct 12, 2017	Supplement 31Labeling · Standard review	Approved	Label Letter
Sep 13, 2017	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 29, 2016	Supplement 28Manufacturing · Standard review	Approved	None posted
Jan 28, 2016	Supplement 27Manufacturing · Standard review	Approved	None posted
Nov 17, 2015	Supplement 26Manufacturing · Standard review	Approved	None posted
Jul 30, 2014	Supplement 25Manufacturing · Standard review	Approved	None posted
Jul 15, 2014	Supplement 24Labeling · Standard review	Approved	Label Letter
Apr 15, 2014	Supplement 22Labeling · Standard review	Approved	Label Letter
Feb 4, 2010	Supplement 19Labeling · Standard review	Approved	Letter
Jan 31, 2007	Supplement 15Labeling · Standard review	Approved	Letter
Aug 27, 2004	Supplement 10Manufacturing · Standard review	Approved	Letter
May 21, 2003	Supplement 9Labeling · Standard review	Approved	Letter Label
Apr 19, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 10, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 7, 2000	Supplement 4Labeling · Standard review	Approved	None posted
Apr 26, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 7, 1999	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Aug 20, 1999	Supplement 3Manufacturing · Standard review	Approved	None posted
Oct 22, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 14, 1998	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 20802
Drugs@FDA: Overview at FDA
Company: Haleon US Holdings

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters