Application 022565

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADVIL CONGESTION RELIEF	IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	TABLET;ORAL	200MG;10MG	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
N022565-001	ADVIL CONGESTION RELIEF	IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	200MG;10MG	TABLET / ORAL		RLD, RS	2010-05-27

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	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022565-001	ADVIL CONGESTION RELIEF	200MG;10MG	TABLET / ORAL	RLD, RS	2010-05-27	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ADVIL SINUS CONGESTION AND PAIN	IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	b1e29c19-fe03-4d2b-b966-0adf4eb4b4cf	2025-07-22	Warnings	Exact identifier application applno (NDA): 022565 application number: NDA022565 ndc (product): 0573-0199
Advil Sinus Congestion and Pain Relief	IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	531abadc-37fd-4953-95bc-a211a2ba6914	2023-03-15	Warnings	Exact identifier application applno (NDA): 022565 application number: NDA022565 ndc (product): 67751-150

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0573-0199	ADVIL SINUS CONGESTION AND PAIN	ibuprofen, phenylephrine hydrochloride	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0199	ADVIL SINUS CONGESTION AND PAIN	ibuprofen, phenylephrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0199	ADVIL SINUS CONGESTION AND PAIN	ibuprofen, phenylephrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0199	ADVIL SINUS CONGESTION AND PAIN	ibuprofen, phenylephrine hydrochloride	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0199	ADVIL SINUS CONGESTION AND PAIN	ibuprofen, phenylephrine hydrochloride	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
52904-782	Advil Sinus Congestion and Pain	ibuprofen, phenylephrine hydrochloride	Select Corporation	NDA	Current
67751-150	Advil Sinus Congestion and Pain Relief	IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	NDA	Current
67751-150	Advil Sinus Congestion and Pain Relief	IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69402	SUPPL	2021-11-23
69382	SUPPL	2021-11-23
64158	SUPPL	2020-07-31
64157	SUPPL	2020-07-31
59302	SUPPL	2019-07-10
59301	SUPPL	2019-07-10
48054	SUPPL	2017-04-18
48047	SUPPL	2017-04-17
17712	SUPPL	2015-04-14
29863	SUPPL	2015-04-02
44778	ORIG	2010-09-23
22058	ORIG	2010-09-23
29862	ORIG	2010-06-03