Healthy Accents Ibuprofen

Product NDC: 55316-299
11-digit product format: 553160299
Labeler code: 55316
Product ID: 55316-299_0c4cc0ba-51a6-4b68-9bc5-4322d50913b0
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DZA Brands LLC
Application: ANDA072096
Marketing category: ANDA
Marketing start: 2013-05-22
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 200 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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	55316-299		D	Discontinued by firm		2026-08-17
excluded package	package	55316-299	55316-299-85	D	Discontinued by firm		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 · 24 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	55316-299-85	`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	55316-299-85	`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	55316-299-85	`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	55316-299-85	`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	55316-299-85	`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	55316-299-85	`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	55316-299-85	`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	55316-299-85	`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	55316-299-85	`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	55316-299-85	`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	55316-299-85	`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	55316-299-85	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A072096-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			1987-12-08

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	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`e64feba35796…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	HEALTHY ACCENTS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [DZA BRANDS LLC]	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	HEALTHY ACCENTS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [DZA BRANDS LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HEALTHY ACCENTS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [DZA BRANDS LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HEALTHY ACCENTS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [DZA BRANDS LLC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	HEALTHY ACCENTS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [DZA BRANDS LLC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	HEALTHY ACCENTS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [DZA BRANDS LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HEALTHY ACCENTS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [DZA BRANDS LLC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	HEALTHY ACCENTS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [DZA BRANDS LLC]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	HEALTHY ACCENTS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [DZA BRANDS LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HEALTHY ACCENTS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [DZA BRANDS LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	HEALTHY ACCENTS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [DZA BRANDS LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	HEALTHY ACCENTS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [DZA BRANDS LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HEALTHY ACCENTS IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [DZA BRANDS LLC]	2

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 4 · 67 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	b5a47efe-222f-4cbd-b649-caafd16a0829	2026-07-29	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	HyVee Inc	e7175dc9-db39-4452-a419-85af179de422	2026-07-16	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
good sense ibuprofen	IBUPROFEN	Bryant Ranch Prepack	d6460cc3-c207-44e0-bf78-ad6fef055ed5	2026-07-09	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	Unit Dose Solutions, Inc.	551535ce-eab0-bb13-e063-6294a90a2070	2026-06-25	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
Berkley and Jensen Ibuprofen	IBUPROFEN	BJWC	cda57e42-6106-46ee-82d1-479a692ee5bb	2026-05-21	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	085dcc1a-e4b0-4d08-9476-72275382d1a1	2026-05-15	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
good sense ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	f1a03b1f-2d87-43cc-b256-bd296ccd09f2	2026-05-13	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	Kroger Company	6307485a-8be6-40ee-899b-00eb3ee8ce61	2026-05-01	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
CounterAct IB	IBUPROFEN	Melaleuca, Inc	7fafc13e-3fee-ace3-e053-2a91aa0ac2ea	2026-03-17	Boxed warning, Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
Leader Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	d673266c-3d2b-479f-9b53-cdd1b8651393	2026-02-25	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	HyVee Inc	4c24c884-55f7-40b4-8d6f-db6144d5ebcb	2026-02-05	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	HyVee Inc	5233c409-3743-4312-9f75-14ded6755b5c	2026-02-02	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
equate ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	b29034a6-657b-426f-a41a-5e64c4bc759d	2026-01-20	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	CVS Pharmacy	ace493e6-91bc-41aa-8e5c-5bc14981de91	2026-01-06	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	Northwind Health Company, LLC	da6c2802-5d15-dbcb-e053-2a95a90a2561	2026-01-01	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
good sense ibuprofen	IBUPROFEN	L. Perrigo Company	70d0a429-27c1-43a5-b2ea-a9919e0910f8	2025-12-22	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	463ea713-6b27-b00b-e063-6394a90a8646	2025-12-18	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	PD-Rx Pharmaceuticals, Inc.	96bff700-bca3-4b94-b8a2-379102721db8	2025-12-15	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
good sense ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	c447fc6b-e9ef-447a-9609-5f893e18dfa7	2025-11-17	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
GOODNOW PAIN RELIEF	IBUPROFEN	Gobrands, Inc	0759085d-6ac3-446b-ac2c-8dc30e32e1d1	2025-11-08	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DZA Brands, LLC Ibuprofen Tablets 200 mg Drug Facts	DZA Brands LLC	2018-12-18	HUMAN OTC DRUG LABEL	3