Application 211733

Type: NDA
Sponsor: PFIZER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	ACETAMINOPHEN; IBUPROFEN	TABLET;ORAL	250MG;125MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	ACETAMINOPHEN; IBUPROFEN	250MG;125MG	TABLET / ORAL		RLD, RS	2020-02-28

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211733-001	11918693	2041-07-09		Drug product	2024-03-26

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211733-001	NP	2023-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211733-001	NP	2023-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211733-001	NP	2023-02-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211733-001	NP	2023-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211733-001	NP	2023-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211733-001	NP	2023-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211733-001	NP	2023-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211733-001	NP	2023-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211733-001	NP	2023-02-28	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N211733-001	NP	2023-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211733-001	NP	2023-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211733-001	NP	2023-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211733-001	NP	2023-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211733-001	NP	2023-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211733-001	NP	2023-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211733-001	NP	2023-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211733-001	NP	2023-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211733-001	NP	2023-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211733-001	NP	2023-02-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211733-001	NP	2023-02-28	`cb3db0bc1861…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ADVIL DUAL ACTION WITH ACETAMINOPHEN	IBUPROFEN, ACETAMINOPHEN	Select Consumer Group	55cd65fc-91bf-4979-e063-6294a90ab9b7	2026-07-04	Warnings	Exact identifier application applno (NDA): 211733 application number: NDA211733
Advil Dual Action with Acetaminophen, Travel BASIX	IBUPROFEN, ACETAMINOPHEN TABLET, FILM COATED	Lil' Drug Store Products, Inc.	030d9bca-a934-6ef9-e063-6394a90a8277	2025-12-01	Warnings	Exact identifier application applno (NDA): 211733 application number: NDA211733
ADVIL DUAL ACTION WITH ACETAMINOPHEN	IBUPROFEN, ACETAMINOPHEN	Haleon US Holdings LLC	f5ea858e-76d9-4777-b3dc-5d614f66d485	2025-04-21	Warnings	Exact identifier application applno (NDA): 211733 application number: NDA211733 ndc (product): 0573-0147
ADVIL DUAL ACTION WITH ACETAMINOPHEN Back Pain	IBUPROFEN, ACETAMINOPHEN	Haleon US Holdings LLC	acaa9806-e552-44f2-a680-b8bb64c49e1f	2024-04-24	Warnings	Exact identifier application applno (NDA): 211733 application number: NDA211733
ADVIL DUAL ACTION WITH ACETAMINOPHEN	IBUPROFEN, ACETAMINOPHEN	Navajo Manufacturing Company Inc.	bd0d7812-4e42-b533-e053-2995a90ae1f9	2024-04-15	Warnings	Exact identifier application applno (NDA): 211733 application number: NDA211733 ndc (product): 67751-211

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0573-0147	ADVIL DUAL ACTION WITH ACETAMINOPHEN	Ibuprofen, Acetaminophen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0147	ADVIL DUAL ACTION WITH ACETAMINOPHEN	Ibuprofen, Acetaminophen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0147	ADVIL DUAL ACTION WITH ACETAMINOPHEN	Ibuprofen, Acetaminophen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0147	ADVIL DUAL ACTION WITH ACETAMINOPHEN	Ibuprofen, Acetaminophen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
67751-211	ADVIL DUAL ACTION WITH ACETAMINOPHEN	Ibuprofen, Acetaminophen	Navajo Manufacturing Company Inc.	NDA	Current
67751-211	ADVIL DUAL ACTION WITH ACETAMINOPHEN	Ibuprofen, Acetaminophen	Navajo Manufacturing Company Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82170	SUPPL	2025-06-02
82169	SUPPL	2025-05-08
70067	SUPPL	2022-02-03
69979	SUPPL	2022-01-27
69836	SUPPL	2022-01-11
69835	SUPPL	2022-01-11
62395	ORIG	2020-03-31
62010	ORIG	2020-02-28
62009	ORIG	2020-02-28