Ibuprofen

Product NDC: 55319-186
Requested package NDC: 55319-186-25
11-digit product format: 553190186
Labeler code: 55319
Product ID: 55319-186_8ca729b7-468f-4329-ac93-e9ce43a40db3
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET
Route: ORAL
Labeler: Family Dollar (FAMILY WELLNESS)
Application: ANDA076460
Marketing category: ANDA
Marketing start: 2015-05-04
Marketing end: 2024-04-26
Substance: IBUPROFEN
Active strength: 200 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55319-186	55319-186-25	D	Discontinued by firm		2026-08-11

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 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
A076460-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2003-11-26

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	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	IBUPROFEN TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	IBUPROFEN TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	IBUPROFEN TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBUPROFEN TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	IBUPROFEN TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	IBUPROFEN TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBUPROFEN TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	IBUPROFEN TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	IBUPROFEN TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBUPROFEN TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	IBUPROFEN TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	IBUPROFEN TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	IBUPROFEN TABLET [FAMILY DOLLAR (FAMILY WELLNESS)]	1

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	PLD Acquisitions LLC DBA Avma Pharma Solutions	c6dcc329-bab5-41ab-94e7-625e07628fd6	2025-01-28	Warnings	Exact identifier application applno (ANDA): 076460 application number: ANDA076460
Ibuprofen	IBUPROFEN	PLD Acquisitions LLC DBA Avma Pharma Solutions	1662a495-4f6a-4515-a405-557681e1a496	2023-02-09	Warnings	Exact identifier application applno (ANDA): 076460 application number: ANDA076460

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55319-186-25	55319018625	1 BOTTLE, PLASTIC in 1 BOX (55319-186-25) > 250 TABLET in 1 BOTTLE, PLASTIC	2015-05-04	2024-04-26	No	No	Current