Ibuprofen

Product NDC: 55319-398
11-digit product format: 553190398
Labeler code: 55319
Product ID: 55319-398_b7b4d9ae-0bc3-9df4-e053-2995a90a4ede
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: FAMILY DOLLAR
Application: ANDA202312
Marketing category: ANDA
Marketing start: 2020-01-31
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 200 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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	55319-398		I	Inactivated by FDA		2026-08-17
excluded package	package	55319-398	55319-398-10	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 · 32 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	55319-398-10	`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	55319-398-10	`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	55319-398-10	`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	55319-398-10	`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	55319-398-10	`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	55319-398-10	`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	55319-398-10	`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	55319-398-10	`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	55319-398-10	`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	55319-398-10	`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	55319-398-10	`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	55319-398-10	`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	55319-398-10	`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	55319-398-10	`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	55319-398-10	`1332a3947898…`	`d4bfe170f9cd…`
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	55319-398-10	`e2bbac7714bc…`	`27bdfed8d636…`

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
A202312-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2016-10-07

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	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202312-001	IBUPROFEN	200MG	TABLET / ORAL	2016-10-07	`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#

Effective, Related label table
Effective	Related label
2023-01-30	Ibuprofen IB Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
2020-12-30	Ibuprofen IB Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
2020-09-27	Ibuprofen IB Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
2020-09-25	Ibuprofen IB Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**
2020-07-22	Ibuprofen IB Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55319-398-10	Ibuprofen	100 in 1 BOTTLE	TABLET	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55319-398	IBUPROFEN TABLET [FAMILY DOLLAR]	2	Legacy NDC, 1 package rows	20201231_97666c24-969f-9e76-e053-2a95a90a4432.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 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Shield Pharmaceuticals Corp	22102461-0196-4ef0-aef4-66997d74d118	2026-08-10	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	Harris Teeter	637210f0-6494-4656-8b2b-14d7476cb127	2026-07-29	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
IBUPROFEN	IBUPROFEN	Harris Teeter	14515409-736f-4119-b6a0-cb19ee2e948e	2026-07-29	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
IBUPROFEN	IBUPROFEN	Granules India Limited	97516b9f-219a-429d-850d-1fe9fd66646b	2026-06-15	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	HYVEE INC	459fc063-0664-09b7-e063-6394a90a89e0	2026-01-13	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	HYVEE INC	459fc670-32a3-61a6-e063-6294a90aea5a	2026-01-13	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES,LLC.	a568fd1e-9bf0-3c03-e053-2a95a90a45b7	2025-12-19	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	TOPCO ASSOCIATES LLC	1a00c85b-2ba5-32c3-e063-6294a90af148	2025-12-19	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	Walgreens	07edb8d0-2fa8-4b40-e063-6294a90a2fe9	2025-12-19	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS LLC.	a3c1a61b-88fc-419c-e053-2a95a90ac0c3	2025-12-18	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	VALU MERCHANDISERS COMPANY	a42f96c4-322d-4714-9435-7b5a4e8b6ae5	2025-12-11	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	VALU MERCHANDISERS COMPANY	36b95840-f621-437a-bf49-406d320964da	2025-12-11	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	9c1ded4e-1d3b-1ab6-e053-2995a90aa80d	2025-12-10	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	9c1cc205-b9e3-03fc-e053-2995a90aaffb	2025-12-10	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
IBUPROFEN	IBUPROFEN	RETAIL BUSINESS SERVICES , LLC.	8f9f40f5-625d-3f2e-e053-2a95a90a438b	2025-11-18	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	RETAIL BUSINESS SERVICES , LLC.	8f9f42a7-c2d8-4a51-e053-2a95a90a1677	2025-11-18	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	Demoulas Super Markets, Inc	39802e26-1028-d2fe-e063-6394a90a24c7	2025-07-16	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	Marc Glassman, Inc.	9714e804-fadb-103d-e053-2a95a90ad765	2025-07-15	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	MARC GLASSMAN, INC.	9714de6b-068b-d6b9-e053-2995a90a3b27	2025-07-15	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312
Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	8fecb3a8-d288-cacf-e053-2a95a90ae238	2025-07-01	Warnings	Exact identifier application applno (ANDA): 202312 application number: ANDA202312

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	97666c24-969f-9e76-e053-2a95a90a4432	2
310965	ibuprofen 200 MG Oral Tablet	SCD	97666c24-969f-9e76-e053-2a95a90a4432	2
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	97666c24-969f-9e76-e053-2a95a90a4432	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55319-398-10	55319039810	100 TABLET in 1 BOTTLE (55319-398-10)	100 tablet	2020-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ibuprofen IB Tablets USP, 200 mg Pain Reliever/Fever Reducer (NSAID)**	FAMILY DOLLAR	2020-12-30	HUMAN OTC DRUG LABEL	2