ADVIL DUAL ACTION WITH ACETAMINOPHEN

Product NDC: 85237-1886
11-digit product format: 852371886
Labeler code: 85237
Product ID: 85237-1886_55cd6613-74f5-3d01-e063-6294a90a6cca
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen, Acetaminophen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Select Consumer Group
Application: NDA211733
Marketing category: NDA
Marketing start: 2020-07-27
Substance: IBUPROFEN; ACETAMINOPHEN
Active strength: 125; 250 mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: 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
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
2026-09-14 22:38:34	2026-08	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211733-001	ADVIL DUAL ACTION WITH ACETAMINOPHEN	250MG;125MG	TABLET / ORAL	RLD, RS	2020-02-28	`caaa826d4ba7…`
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
2026-09-14 22:38:34	2026-08	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211733-001	11918693	2041-07-09	Drug product	2024-03-26	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: ADVIL DUAL ACTION WITH ACETAMINOPHEN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	125 mg/1
ACETAMINOPHEN	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2387532	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
55cd65fc-91bf-4979-e063-6294a90ab9b7	Available on FDA.report

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 ndc (product): 85237-1886
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85237-1886-1	85237188601	1 POUCH in 1 BLISTER PACK (85237-1886-1) / 2 TABLET, FILM COATED in 1 POUCH (85237-1886-0)	1 pouch	2024-04-09	No	No	Current
85237-1886-2	85237188602	2 POUCH in 1 BLISTER PACK (85237-1886-2) / 2 TABLET, FILM COATED in 1 POUCH (85237-1886-0)	2 pouch	2024-04-09	No	No	Current
85237-1886-4	85237188604	25 POUCH in 1 CARTON (85237-1886-4) / 2 TABLET, FILM COATED in 1 POUCH (85237-1886-0)	25 pouch	2024-04-09	No	No	Current
85237-1886-6	85237188606	50 POUCH in 1 CARTON (85237-1886-6) / 2 TABLET, FILM COATED in 1 POUCH (85237-1886-0)	50 pouch	2024-04-09	No	No	Current
85237-1886-7	85237188607	3 POUCH in 1 BLISTER PACK (85237-1886-7) / 2 TABLET, FILM COATED in 1 POUCH (85237-1886-0)	3 pouch	2024-04-09	No	No	Current