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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 020802

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NDA 020802 describes EXCEDRIN (MIGRAINE RELIEF), which is a drug marketed by Haleon Us Holdings and is included in one NDA. It is available from six suppliers. Additional details are available on the EXCEDRIN (MIGRAINE RELIEF) profile page.

The generic ingredient in EXCEDRIN (MIGRAINE RELIEF) is acetaminophen; aspirin; caffeine. There are sixty-six drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the acetaminophen; aspirin; caffeine profile page.

Summary for 020802

Tradename:	EXCEDRIN (MIGRAINE RELIEF)
Applicant:	Haleon Us Holdings
Ingredient:	acetaminophen; aspirin; caffeine
Patents:	0

Pharmacology for NDA: 020802

Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Central Nervous System Stimulation Decreased Platelet Aggregation Decreased Prostaglandin Production

Suppliers and Packaging for NDA: 020802

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802	NDA	Haleon US Holdings LLC	0067-2035	0067-2035-20	1 BOTTLE in 1 CARTON (0067-2035-20) / 20 TABLET, COATED in 1 BOTTLE
EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802	NDA	Haleon US Holdings LLC	0067-2035	0067-2035-80	1 BOTTLE in 1 CARTON (0067-2035-80) / 80 TABLET, COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	250MG;250MG;65MG
Approval Date:	Jan 14, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 020802

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802-001	Jan 14, 1998	⤷ Get Started Free	⤷ Get Started Free
Haleon Us Holdings	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802-001	Jan 14, 1998	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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