Pain Relief

Product NDC: 59726-167
11-digit product format: 597260167
Labeler code: 59726
Product ID: 59726-167_0720cdb6-3835-48a2-8530-c6f47a96142a
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, COATED
Route: ORAL
Labeler: P and L Development of New York Corporation
Application: ANDA072199
Marketing category: ANDA
Marketing start: 2012-09-28
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 200 mg/1
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	59726-167		D	Discontinued by firm		2026-10-05
excluded package	package	59726-167	59726-167-40	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59726-167-40	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59726-167-40	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59726-167-40	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59726-167-40	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59726-167-40	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59726-167-40	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59726-167-40	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59726-167-40	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59726-167-40	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59726-167-40	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59726-167-40	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59726-167-40	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	59726-167-40	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A072199-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			1988-05-23

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072199-001	IBUPROFEN	200MG	TABLET / ORAL	1988-05-23	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAIN RELIEF (IBUPROFEN) TABLET, COATED [P AND L DEVELOPMENT OF NEW YORK CORPORATION]	2

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
Ibuprofen (NSAID) Pain Releiver/ Fever Reducer	IBUPROFEN	Amneal Pharmaceuticals of New York LLC	a8c6bc4e-1e48-4613-8cbf-8c5cd9d51ad0	2023-12-31	Warnings	Exact identifier application applno (ANDA): 072199 application number: ANDA072199