Ibuprofen

Product NDC: 58602-852
11-digit product format: 586020852
Labeler code: 58602
Product ID: 58602-852_43c94480-78d1-4a23-91d4-1d49fea72cb7
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurohealth LLC
Application: ANDA207753
Marketing category: ANDA
Marketing start: 2022-07-18
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
A207753-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2018-06-29

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207753-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2018-06-29	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ibuprofen
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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310964	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
43c94480-78d1-4a23-91d4-1d49fea72cb7	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58602-852-32	Ibuprofen	180 in 1 BOTTLE	CAPSULE	180		1
58602-852-38	Ibuprofen	300 in 1 BOTTLE	CAPSULE	300		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-852	IBUPROFEN CAPSULE [AUROHEALTH LLC]	1	Current NDC, Legacy NDC, 2 package rows	20220722_43c94480-78d1-4a23-91d4-1d49fea72cb7.zip

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Aurohealth LLC	43c94480-78d1-4a23-91d4-1d49fea72cb7	2026-06-05	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753 ndc (product): 58602-852
Ibuprofen	IBUPROFEN	P & L Development, LLC	ce215099-91b0-43fd-8ac9-17fe6508842c	2025-11-11	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	da9d0301-ec14-40c5-b0b9-17096913a849	2025-11-11	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	Better Living Brands LLC	f6ef7f73-b5ab-4c82-e053-6394a90ac81e	2023-09-22	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	RITE AID CORPORATION	de158883-1175-18fc-e053-2995a90a3c96	2023-04-12	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	Aurohealth LLC	e1b49257-d226-457f-8f2d-9a757a65bbcb	2022-09-06	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	Aurohealth LLC	7779c369-50bf-4cde-9015-ff3fb35e128e	2022-05-16	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753
Ibuprofen	IBUPROFEN	Aurohealth LLC	3b0e77a1-b49d-4c67-81dd-66450dabcf3b	2022-03-04	Warnings	Exact identifier application applno (ANDA): 207753 application number: ANDA207753

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
310964	ibuprofen 200 MG Oral Capsule	PSN	43c94480-78d1-4a23-91d4-1d49fea72cb7	1
310964	ibuprofen 200 MG Oral Capsule	SCD	43c94480-78d1-4a23-91d4-1d49fea72cb7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-852-32	58602085232	180 CAPSULE in 1 BOTTLE (58602-852-32)	180 capsule	2022-07-18	0000-00-00	No	No	Current
58602-852-38	58602085238	300 CAPSULE in 1 BOTTLE (58602-852-38)	300 capsule	2022-07-18	0000-00-00	No	No	Current