Application 019771

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	TABLET;ORAL	200MG;30MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N019771-001	ADVIL COLD AND SINUS	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL		RLD, RS	1989-09-19

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019771-001	ADVIL COLD AND SINUS	200MG;30MG	TABLET / ORAL	RLD, RS	1989-09-19	`f41ea6bd6efb…`

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 AND PSEUDOEPHEDRINE HYDROCHLORIDE	Haleon US Holdings LLC	fac22a47-f0de-4505-fd8a-768430cda0c1	2025-06-13	Warnings	Exact identifier application applno (NDA): 019771 application number: NDA019771 ndc (product): 0573-0180

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
0573-0180	ADVIL COLD AND SINUS	ibuprofen and pseudoephedrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0180	ADVIL COLD AND SINUS	ibuprofen and pseudoephedrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0180	ADVIL COLD AND SINUS	IBUPROFEN and PSEUDOEPHEDRINE HYDROCHLORIDE	Pfizer Consumer Healthcare	NDA	Current
0573-0180	ADVIL COLD AND SINUS	ibuprofen and pseudoephedrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69400	SUPPL	2021-11-23
69377	SUPPL	2021-11-23
47701	SUPPL	2017-03-24
47665	SUPPL	2017-03-24
19185	SUPPL	2010-09-07
1593	SUPPL	2009-05-26
19184	SUPPL	2008-06-23
19183	SUPPL	2006-04-20
1592	SUPPL	2006-03-01
1591	SUPPL	2003-10-22
33933	SUPPL	2003-06-10