Ibuprofen

Product NDC: 53943-115
11-digit product format: 539430115
Labeler code: 53943
Product ID: 53943-115_f5312ee8-5fef-4c62-af83-0f8ef81bdd53
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Discount Drug Mart
Application: ANDA091237
Marketing category: ANDA
Marketing start: 2013-06-20
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#

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	53943-115		I	Inactivated by FDA		2026-08-17
excluded package	package	53943-115	53943-115-01	I	Inactivated by FDA		2026-08-17

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53943-115-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53943-115-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53943-115-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53943-115-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53943-115-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53943-115-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53943-115-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53943-115-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53943-115-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53943-115-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53943-115-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53943-115-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53943-115-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53943-115-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53943-115-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53943-115-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53943-115-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53943-115-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53943-115-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53943-115-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53943-115-01	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A091237-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-02-08

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091237-001	IBUPROFEN	200MG	TABLET / ORAL	2011-02-08	`e64feba35796…`

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
53943-115-01	2020-01-31	C162847	48780-1	9d75b9d0-12ac-f424-e053-dadaa90a57ce	f5312ee8-5fef-4c62-af83-0f8ef81bdd53

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53943-115-01	Ibuprofen	1 in 1 CARTON	TABLET	1		1
53943-115-01	Ibuprofen	100 in 1 BOTTLE	TABLET	100		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [DISCOUNT DRUG MART]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [DISCOUNT DRUG MART]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [DISCOUNT DRUG MART]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [DISCOUNT DRUG MART]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [DISCOUNT DRUG MART]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBUPROFEN TABLET [DISCOUNT DRUG MART]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [DISCOUNT DRUG MART]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	IBUPROFEN TABLET [DISCOUNT DRUG MART]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [DISCOUNT DRUG MART]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	IBUPROFEN TABLET [DISCOUNT DRUG MART]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [DISCOUNT DRUG MART]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-115	IBUPROFEN TABLET [DISCOUNT DRUG MART]	1	Legacy NDC, 2 package rows	20130620_f5312ee8-5fef-4c62-af83-0f8ef81bdd53.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	CVS Pharmacy. Inc.	d4336a7c-fb9f-1fbe-e053-2995a90af365	2025-09-13	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
Ibuprofen	IBUPROFEN	CVS Pharmacy.Inc.	cd0c3404-9e9d-bfad-e053-2995a90a8719	2025-09-13	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES,INC	82aad715-f652-471b-840c-5151c66e5ade	2024-08-28	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
Ibuprofen	IBUPROFEN TABLETS USP, 200MG	KROGER COMPANY	0fbe42d0-b5f2-0780-e063-6394a90a4ecb	2024-04-13	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
IBUPROFEN	IBUPROFEN	WALGREENS	76f4cc25-a77e-6245-e053-2a91aa0af7ae	2024-03-18	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
IBUPROFEN	IBUPROFEN	WALGREENS	76f15be2-4682-5015-e053-2991aa0af0d2	2024-03-15	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
IBUPROFEN	IBUPROFEN	TARGET CORPORATION	8e872c8d-28e2-cd49-e053-2995a90a469f	2024-01-03	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
Ibuprofen	IBUPROFEN TABLETS USP, 200MG	BETTER LIVING BRANDS, LLC	eb60a1e5-fb6e-360f-e053-2a95a90ade04	2023-08-03	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
Ibuprofen	IBUPROFEN	CARDINAL HEALTH	dfbbde4f-633d-6d57-e053-2a95a90ad82f	2022-05-24	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
IBUPROFEN	IBUPROFEN	RITE AID	a7abf95e-d444-42da-e053-2995a90a88d3	2022-01-03	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
IBUPROFEN	IBUPROFEN	RITE AID	a7ac8b55-2758-400e-e053-2995a90a0eed	2022-01-03	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	859d7190-586f-4766-a7e7-9e800a72d58b	2021-12-21	Warnings	Exact identifier application applno (ANDA): 091237 application number: ANDA091237

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	f5312ee8-5fef-4c62-af83-0f8ef81bdd53	1
310965	ibuprofen 200 MG Oral Tablet	SCD	f5312ee8-5fef-4c62-af83-0f8ef81bdd53	1
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	f5312ee8-5fef-4c62-af83-0f8ef81bdd53	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53943-115-01	53943011501	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen - Discount Drug Mart \| Marksans Pharma Limited	Discount Drug Mart \| Marksans Pharma Limited	2013-06-18	Human OTC Drug Label	1