Application 021374

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADVIL COLD AND SINUS	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021374-001	ADVIL COLD AND SINUS	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL		RLD, RS	2002-05-30

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021374-001	ADVIL COLD AND SINUS	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	RLD, RS	2002-05-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021374-001	ADVIL COLD AND SINUS	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	RLD, RS	2002-05-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021374-001	ADVIL COLD AND SINUS	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	RLD, RS	2002-05-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021374-001	ADVIL COLD AND SINUS	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE / ORAL	RLD, RS	2002-05-30	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ADVIL COLD AND SINUS	IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE	Haleon US Holdings LLC	0da9ed22-bfb4-d61b-110b-0c7760332a98	2026-07-29	Warnings	Exact identifier application applno (NDA): 021374 application number: NDA021374 ndc (product): 0573-0184

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0573-0184	ADVIL COLD AND SINUS	ibuprofen, pseudoephedrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0184	ADVIL COLD AND SINUS	ibuprofen, pseudoephedrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0184	ADVIL COLD AND SINUS	ibuprofen, pseudoephedrine hydrochloride	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0184	ADVIL COLD AND SINUS	ibuprofen, pseudoephedrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69401	SUPPL	2021-11-23
69381	SUPPL	2021-11-23
47816	SUPPL	2017-04-03
47813	SUPPL	2017-04-03
27638	SUPPL	2011-03-16
5223	SUPPL	2009-05-27
27637	SUPPL	2008-06-24
27635	SUPPL	2006-04-20
27636	SUPPL	2005-12-15
42128	ORIG	2004-05-26
15340	SUPPL	2003-10-22
5222	SUPPL	2003-10-22
36795	ORIG	2002-05-30
27634	ORIG	2002-05-30