Pain Relief

Product NDC: 52904-447
11-digit product format: 529040447
Labeler code: 52904
Product ID: 52904-447_9b05aa4c-903e-43ec-a79f-ec675bc6e77a
Type: HUMAN OTC DRUG
Nonproprietary name: IBUPROFEN
Dosage form: TABLET
Route: ORAL
Labeler: Select Corporation
Application: ANDA091239
Marketing category: ANDA
Marketing start: 2012-10-15
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 200 mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	52904-447		I	Inactivated by FDA		2026-07-31
excluded package	package	52904-447	52904-447-02	I	Inactivated by FDA		2026-07-31

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
A091239-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-02-01

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A091239-001	IBUPROFEN	200MG	TABLET / ORAL			2011-02-01	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Grocery Outlet, Inc.	44660e1d-79c2-34ce-e063-6294a90ade3f	2026-03-17	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	Kroger Company	bc173f1b-2e44-2c2e-e053-2a95a90a89c4	2025-09-24	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	TIME CAP LABORATORIES,INC	f58d35f9-e44b-417b-98ce-0766b537cd2f	2025-06-12	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	WALGREENS	7653b33c-7489-10db-e053-2991aa0ab508	2025-06-06	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
AeroTab Ibuprofen	IBUPROFEN TABLET	Aero Healthcare	ddd0f7fb-ae4b-c584-e053-2a95a90a0984	2025-02-26	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
VALUMEDS IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS LLC	a6d4ceb0-2b79-496a-aa1e-27edd507ced0	2024-12-10	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	SAM'S WEST INC	16595d75-6e74-0839-e063-6394a90abc13	2024-05-28	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	WALGREENS	746f79aa-3036-1b9b-e053-2a91aa0a1db6	2024-03-18	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN CA	IBUPROFEN	TARGET CORPORATION	8e8684fa-095e-c6d6-e053-2a95a90a15b4	2024-01-03	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	TARGET CORPORATION	8e86ae68-7687-79d6-e053-2995a90ac274	2024-01-03	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS, LLC	eb613c44-e125-0f40-e053-2995a90a7ca5	2023-10-02	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS, LLC	eb60e636-41fe-49fb-e053-2a95a90a0616	2023-09-29	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
ibuprofen	IBUPROFEN	DOLGENCORP INC	8f1358aa-495a-23da-e053-2995a90aa430	2023-01-02	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	a7aa790a-6d6c-7929-e053-2995a90a1cf8	2022-01-04	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	3c8df1e5-61bc-4e70-b6b9-8973986ad589	2021-12-21	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239
IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	a7abac4c-7695-cfe8-e053-2a95a90ac1cd	2021-10-30	Warnings	Exact identifier application applno (ANDA): 091239 application number: ANDA091239

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52904-447-02	2020-01-31	C162847	48780-1	9d75b9d1-1710-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52904-447-02	Pain Relief	2 in 1 PACKET	TABLET	2		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]	1
POLYETHYLENE GLYCOL 300	INACTIVE INGREDIENT	5655G9Y8AQ	PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52904-447	PAIN RELIEF (IBUPROFEN) TABLET [SELECT CORPORATION]	1	Legacy NDC, 1 package rows	20121106_87feec83-7b0a-41b5-972f-80592bab7c2d.zip

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
310965	ibuprofen 200 MG Oral Tablet	PSN	87feec83-7b0a-41b5-972f-80592bab7c2d	1
310965	ibuprofen 200 MG Oral Tablet	SCD	87feec83-7b0a-41b5-972f-80592bab7c2d	1
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	87feec83-7b0a-41b5-972f-80592bab7c2d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52904-447-02	52904044702	2 in 1 PACKET	Historical