ADVIL

Product NDC: 85237-1786
11-digit product format: 852371786
Labeler code: 85237
Product ID: 85237-1786_3ca7531b-364f-d68e-e063-6294a90a3ded
Type: HUMAN OTC DRUG
Nonproprietary name: ibuprofen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Select Consumer Group
Application: NDA018989
Marketing category: NDA
Marketing start: 1984-05-18
Substance: IBUPROFEN
Active strength: 200 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: 2026-12-31
Current FDA listing: 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
N018989-001	ADVIL	IBUPROFEN	200MG	TABLET / ORAL		RLD, RS	1984-05-18

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: ADVIL
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
153008	Internal RxNorm lookup
310965	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
3ca752d8-957c-21b4-e063-6294a90a5285	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85237-1786-1	ADVIL	1 in 1 POUCH	TABLET, COATED	1		1
85237-1786-1	ADVIL	1 in 1 BLISTER PACK	TABLET, COATED	1		1

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ADVIL	IBUPROFEN	Select Consumer Group	3ca752d8-957c-21b4-e063-6294a90a5285	2026-07-03	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989 ndc (product): 85237-1786
Advil	IBUPROFEN	Navajo Manufacturing Company Inc.	4a64522f-b7d8-47f7-bf07-c9e8f1086425	2026-04-08	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989
ADVIL	IBUPROFEN	Haleon US Holdings LLC	1a665e64-9f30-be37-4a83-38789f1f1e89	2026-03-12	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989
Advil	IBUPROFEN	JC World Bell Wholesale Co., Inc.	0b83c9ed-3630-4c5c-9020-cf38183a6500	2025-06-27	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989
Advil	IBUPROFEN	Lil' Drug Store Products, Inc.	772360bd-8631-4d24-b4db-5a7e6e1d9a13	2025-01-27	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989
Advil	IBUPROFEN TABLETS, COATED	Lil' Drug Store Products, Inc.	dd302e18-39e9-7e1a-e053-2a95a90a5f7c	2024-07-17	Warnings	Exact identifier application applno (NDA): 018989 application number: NDA018989

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
153008	Advil 200 MG Oral Tablet	PSN	3ca752d8-957c-21b4-e063-6294a90a5285	1
310965	ibuprofen 200 MG Oral Tablet	PSN	3ca752d8-957c-21b4-e063-6294a90a5285	1
153008	ibuprofen 200 MG Oral Tablet [Advil]	SBD	3ca752d8-957c-21b4-e063-6294a90a5285	1
310965	ibuprofen 200 MG Oral Tablet	SCD	3ca752d8-957c-21b4-e063-6294a90a5285	1
153008	Advil 200 MG Oral Tablet	SY	3ca752d8-957c-21b4-e063-6294a90a5285	1
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	3ca752d8-957c-21b4-e063-6294a90a5285	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85237-1786-1	85237178601	1 POUCH in 1 BLISTER PACK (85237-1786-1) / 1 TABLET, COATED in 1 POUCH	1 pouch	1984-05-18	No	No	Current
85237-1786-2	85237178602	2 POUCH in 1 BLISTER PACK (85237-1786-2) / 2 TABLET, COATED in 1 POUCH (85237-1786-0)	2 pouch	1984-05-18	0		Current
85237-1786-4	85237178604	25 POUCH in 1 BOX (85237-1786-4) / 2 TABLET, COATED in 1 POUCH (85237-1786-0)	25 pouch	1984-05-18	0		Current
85237-1786-6	85237178606	50 POUCH in 1 BOX (85237-1786-6) / 2 TABLET, COATED in 1 POUCH (85237-1786-0)	50 pouch	1984-05-18	0		Current
85237-1786-7	85237178607	3 POUCH in 1 BLISTER PACK (85237-1786-7) / 2 TABLET, COATED in 1 POUCH (85237-1786-0)	3 pouch	1984-05-18	0		Current