caring mill ibuprofen

Product NDC: 81522-604
11-digit product format: 815220604
Labeler code: 81522
Product ID: 81522-604_f54d3f29-b25d-4e30-802a-13667fe98feb
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: FSA Store Inc.
Application: ANDA072096
Marketing category: ANDA
Marketing start: 2021-07-27
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 200 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	81522-604		D	Discontinued by firm	2026-10-05
excluded package	package	81522-604	81522-604-71	D	Discontinued by firm	2026-10-05
excluded package	package	81522-604	81522-604-78	D	Discontinued by firm	2026-10-05
excluded package	package	81522-604	81522-604-90	D	Discontinued by firm	2026-10-05

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
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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A072096-001	IBUPROFEN	200MG	TABLET / ORAL	1987-12-08	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81522-604	CARING MILL IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [FSA STORE INC.]	2	Legacy NDC	20210806_9e3c8c64-0aee-4846-84f9-42f47e360c33.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 3 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equate Ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	01e9b5b9-cb49-4bfa-9a90-ece8940bf768	2025-02-11	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
Good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	a07c45b4-dc98-4b73-a1c1-84b108cf37e9	2025-01-03	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	H E B	a340ed68-debb-4c1e-97eb-82f6e9e3854f	2024-12-02	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
365 whole foods market ibuprofen	IBUPROFEN	Whole Foods Market, INC.	e914472b-c785-4c73-b37c-4d459166cf41	2024-11-26	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
dg health ibuprofen	IBUPROFEN	Dolgencorp, LLC	fd27d4e1-8edf-4bc3-a593-6be5c3345ed0	2024-11-13	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
good sense ibuprofen	IBUPROFEN	A-S Medication Solutions	9ac095d2-ba19-4da1-acc9-85f7b4ae304d	2024-11-04	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
equate ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	307b0257-d636-416b-828a-f901782e9b10	2024-09-13	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	Bryant Ranch Prepack	22cb2ccc-ba4d-4069-8334-f886f0e3e802	2024-07-12	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
IBUPROFEN 100	IBUPROFEN	JHK Inc dba American Safety & First Aid	218f6df9-dd04-45b6-8a45-3276691abee2	2024-04-25	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	H E B	e00acbc0-352e-4ba1-8433-18a3079f6743	2024-04-12	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
pain relief	IBUPROFEN	Meijer, Inc.	1f965703-3262-4dd1-b4f8-6341786553b1	2024-02-07	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
good sense ibuprofen	IBUPROFEN	A-S Medication Solutions	57af05fc-30b9-4487-9a37-fb35dac4acf7	2024-01-29	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
dg health ibuprofen	IBUPROFEN	Dolgencorp Inc	98492b9f-8f48-42dd-b026-c37dcdc5f888	2024-01-08	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
foster and thrive ibuprofen	IBUPROFEN	Strategic Sourcing Services LLC	68d67a25-e669-47c7-8410-9f304b914ff1	2023-10-31	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
ibuprofen	IBUPROFEN	Meijer Distribution Inc	e578de96-747e-4104-8db6-e6521e6052a5	2023-10-09	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
Signature Care Ibuprofen	IBUPROFEN	Safeway	93edca03-fdf1-453f-8efe-5f0b8eef41e4	2023-09-28	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
betr remedies ibuprofen	IBUPROFEN	Live Betr LLC	0a50820f-1dfa-45b5-824f-2c28822fc6c6	2023-07-26	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
Good Sense Ibuprofen	IBUPROFEN	L. Perrigo Company	f9af5970-18ca-46d5-8d6c-c0fec22a66d5	2023-07-21	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
good sense ibuprofen	IBUPROFEN	L. Perrigo Company	9164f7e8-81a0-4b71-a2b3-111b2a7541bb	2023-07-12	Warnings	Exact identifier application applno (ANDA): 072096 application number: ANDA072096
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	3329f487-675d-440c-b7c5-d17a2b024275	2023-05-31	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81522-604-71	81522060471	1 BOTTLE in 1 CARTON (81522-604-71) > 50 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-07-27	0000-00-00	No	No	Current
81522-604-78	81522060478	1 BOTTLE in 1 CARTON (81522-604-78) > 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-07-27	0000-00-00	No	No	Current
81522-604-90	81522060490	500 TABLET, FILM COATED in 1 BOTTLE (81522-604-90)		2021-07-29	0000-00-00	No	No	Current