careone ibuprofen

Product NDC: 41520-933
11-digit product format: 415200933
Labeler code: 41520
Product ID: 41520-933_b8327cde-941b-4e04-99a7-0414b6d2cb1b
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: American Sales Company
Application: ANDA076359
Marketing category: ANDA
Marketing start: 2017-12-21
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 100 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	41520-933		D	Discontinued by firm		2026-10-05
excluded package	package	41520-933	41520-933-62	D	Discontinued by firm		2026-10-05

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	41520-933-62	`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	41520-933-62	`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	41520-933-62	`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	41520-933-62	`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	41520-933-62	`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	41520-933-62	`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	41520-933-62	`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	41520-933-62	`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	41520-933-62	`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	41520-933-62	`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	41520-933-62	`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	41520-933-62	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076359-001	IBUPROFEN	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL			2004-01-16
A076359-002	IBUPROFEN	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL		RS	2004-01-16

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076359-001	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		2004-01-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076359-002	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL	RS	2004-01-16	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

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 2 of 2 · 37 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
childrens ibuprofen	IBUPROFEN	Kroger Company	1b78bdeb-efb2-4f5a-af3f-d67d82090847	2025-08-22	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
equate ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	abef43bc-ee9b-4a9c-9cf9-36c323213909	2025-08-21	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
childrens ibuprofen	IBUPROFEN	Meijer Distribution Inc	d42f9f7c-fe4f-45eb-a455-bffb41295fdc	2025-08-20	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
equaline childrens ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	3a166a74-cdc4-4620-b796-750464e15dc0	2025-08-20	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
CHILDRENS IBUPROFEN	IBUPROFEN	Meijer, Inc.	eed4f13d-4bee-4ccc-a651-a6f86d6d1f7b	2025-08-04	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
Childrens Ibuprofen	IBUPROFEN	Publix Super Markets Inc	54ae0273-4d8d-4c3b-85ff-675ba96f00de	2025-07-22	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
topcare childrens ibuprofen	IBUPROFEN	Topco Associates LLC	a88020c0-7982-4307-9836-74de66ea47a5	2025-07-17	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
childrens ibuprofen	IBUPROFEN	Meijer Distribution Inc	cfe27d2a-b602-4b3e-bdcb-14fed4a236ca	2025-07-17	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
childrens ibuprofen	IBUPROFEN	CVS Pharmacy	884d51d8-4774-4dde-b854-32abfb4b712d	2025-05-20	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
Good Sense Childrens Ibuprofen	IBUPROFEN	L. Perrigo Company	a8fc1b0c-dd69-4567-8eea-de4d9b0c7740	2025-05-07	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
foster and thrive childrens ibuprofen ib	IBUPROFEN	Strategic Sourcing Services LLC	37adf659-9a92-428b-ac99-5718f242a4e9	2025-05-07	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
signature care childrens ibuprofen	IBUPROFEN	Safeway	c30fbb8f-a293-4f6e-9495-11402548fe2d	2022-11-15	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
rexall ibuprofen	IBUPROFEN	Dolgencorp, LLC	869185d5-9f34-4d38-9551-dd0b4fc8557d	2021-09-09	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	b17b0aac-55d2-4917-a722-b8587ad643bc	2021-08-13	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	18e5eed7-d3be-4559-93ca-b40ee26c7bd8	2020-09-09	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
Basic Care Childrens Ibuprofen	IBUPROFEN	Amazon.com Services LLC	d53cb3f1-6689-40dd-bdea-fad3a841d482	2020-09-03	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359
childrens ibuprofen	IBUPROFEN	Rite Aid Corporation	af68a4bf-bc49-40c7-812d-035eff474ed9	2020-04-03	Warnings	Exact identifier application applno (ANDA): 076359 application number: ANDA076359

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
41520-933-62	41520093362	1 BOTTLE in 1 CARTON (41520-933-62) > 24 TABLET, CHEWABLE in 1 BOTTLE	1 bottle	2017-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
American Sales Company Ibuprofen Tablets Drug Facts	American Sales Company	2021-03-03	HUMAN OTC DRUG LABEL	4