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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 021394

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NDA 021394 describes ADVIL PM, which is a drug marketed by Haleon Us Holdings and is included in two NDAs. It is available from three suppliers. Additional details are available on the ADVIL PM profile page.

The generic ingredient in ADVIL PM is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.

Summary for 021394

Tradename:	ADVIL PM
Applicant:	Haleon Us Holdings
Ingredient:	diphenhydramine citrate; ibuprofen
Patents:	0

Pharmacology for NDA: 021394

Mechanism of Action	Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 021394

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394	NDA	Haleon US Holdings LLC	0573-0164	0573-0164-04	4 TABLET, COATED in 1 POUCH (0573-0164-04)
ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394	NDA	Haleon US Holdings LLC	0573-0164	0573-0164-05	2 BOTTLE in 1 CARTON (0573-0164-05) / 2 TABLET, COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	38MG;200MG
Approval Date:	Dec 21, 2005	TE:		RLD:	Yes

Expired US Patents for NDA 021394

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ADVIL PM	diphenhydramine citrate; ibuprofen	TABLET;ORAL	021394-001	Dec 21, 2005	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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