kirkland signature ibuprofen ib

Product NDC: 63981-517
11-digit product format: 639810517
Labeler code: 63981
Product ID: 63981-517_075b2997-0456-40bd-890a-63fd44c609a1
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Costco Wholesale Company
Application: ANDA077349
Marketing category: ANDA
Marketing start: 2007-06-22
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63981-517	63981-517-59	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A077349-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL		RS	2005-06-21

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077349-001	IBUPROFEN	200MG	TABLET / ORAL	RS	2005-06-21	`f41ea6bd6efb…`

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: kirkland signature ibuprofen ib
Listing expiration: 2026-12-31

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
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
2fee0f32-0bc7-4d98-b5d4-5a7dad1c2a2c	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
63981-517-59	kirkland signature ibuprofen ib	750 in 1 BOTTLE	TABLET, FILM COATED	750		8
63981-517-90	kirkland signature ibuprofen ib	500 in 1 BOTTLE	TABLET, FILM COATED	500		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63981-517-59	EA - Each	63981-517	7cf76152-ca9e-44e9-8d10-c6ec5ce532db	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63981-517	KIRKLAND SIGNATURE IBUPROFEN IB (IBUPROFEN) TABLET, FILM COATED [COSTCO WHOLESALE COMPANY]	8	Current NDC, Legacy NDC, 2 package rows	20241022_2fee0f32-0bc7-4d98-b5d4-5a7dad1c2a2c.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	90659e83-d989-46a5-9680-3a4f61612511	2026-09-04	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Ibuprofen	IBUPROFEN	H E B	21567c0f-abba-4a40-a0b9-5ce49b3d9648	2026-07-28	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Good Sense ibuprofen	IBUPROFEN	L. Perrigo Company	aebae4b3-18c8-4ecf-b578-1fe7cc50076b	2026-07-22	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB	IBUPROFEN	Select Consumer Group LLC	52c650cf-3085-7b2c-e063-6394a90a797f	2026-05-27	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
CareOne Ibuprofen	IBUPROFEN	American Sales Company	03cdff8a-8890-440d-82b5-54ce809f88cc	2026-02-03	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB, TRAVEL BASIX	IBUPROFEN	Lil' Drug Store Products, Inc.	c2b99756-3e03-4d9f-9ce6-7db879afe3a1	2025-12-10	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Ibuprofen	IBUPROFEN	CVS Pharmacy	93f8101c-1cf7-4cb0-9c00-c57c9f9023c8	2025-10-26	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB	IBUPROFEN	Kenvue Brands LLC	d21129f8-4d96-4e36-bc39-a534306dd77e	2025-10-03	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
leader ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	96da60f7-06a9-438a-ae59-8609fdd1587d	2025-09-25	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
ibuprofen	IBUPROFEN	Publix Super Markets Inc	c5cd3843-8d72-4850-bebe-4ac54e4f43fa	2025-08-21	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
ibuprofen 200	IBUPROFEN	Walgreen Company	49a3d51d-55d1-4b80-ab7b-35c27a937cb9	2025-07-02	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Topcare ibuprofen	IBUPROFEN	Topco Associates LLC	479a0c97-dbd9-47ad-9910-9dd4edf5136f	2025-07-02	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB	IBUPROFEN	Morning Star OTC	e69f00c4-b8ec-4a83-9eea-8cb2835ad776	2025-06-19	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
kirkland signature ibuprofen ib	IBUPROFEN	Costco Wholesale Company	2fee0f32-0bc7-4d98-b5d4-5a7dad1c2a2c	2024-10-14	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349 ndc (product): 63981-517
dg health ibuprofen	IBUPROFEN	Dolgencorp Inc	b514b589-d965-4a21-91b3-fab4019e9d96	2024-04-12	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	5ada3dbe-af87-49db-a6b0-0a1c02111cbf	2024-03-11	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
signature care ibuprofen	IBUPROFEN	Safeway	95904b21-752d-48b4-a882-8d81d2384e1f	2024-02-01	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Good Neighbor Pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	74b227c9-8341-44df-a763-cfeb371c0d28	2023-08-17	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Equate Ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	153bc4ac-427d-426a-9bb8-665487e4b169	2023-04-27	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349
Motrin IB	IBUPROFEN	Jones Healthcare Group - Packaging Services, Inc	6419cc78-27d4-7713-e053-2a91aa0a5a10	2022-04-29	Warnings	Exact identifier application applno (ANDA): 077349 application number: ANDA077349

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	2fee0f32-0bc7-4d98-b5d4-5a7dad1c2a2c	8
310965	ibuprofen 200 MG Oral Tablet	SCD	2fee0f32-0bc7-4d98-b5d4-5a7dad1c2a2c	8
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	2fee0f32-0bc7-4d98-b5d4-5a7dad1c2a2c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63981-517-59	63981051759	750 in 1 BOTTLE					Historical
63981-517-90	63981051790	500 TABLET, FILM COATED in 1 BOTTLE (63981-517-90)	2014-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Costco Wholesale Corp. Ibuprofen IB Tablets Drug Facts	Costco Wholesale Company	2024-10-14	HUMAN OTC DRUG LABEL	8