care one ibuprofen

Product NDC: 41520-660
Requested package NDC: 41520-660-26
11-digit product format: 415200660
Labeler code: 41520
Product ID: 41520-660_bb9cb0af-884c-4855-87c7-ca9ed68dab7f
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: American Sales Company
Application: ANDA074937
Marketing category: ANDA
Marketing start: 2004-05-04
Marketing end: 0000-00-00
Substance: IBUPROFEN
Active strength: 100 mg/5mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	41520-660	41520-660-26	D	Discontinued by firm		2026-08-03

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
A074937-001	CHILDREN'S IBUPROFEN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1998-12-22

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	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	3
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	3
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-660	CARE ONE IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [AMERICAN SALES COMPANY]	8	Legacy NDC	20190119_ab65bbbd-5141-4f3e-884d-4b52d9171003.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 5 · 82 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
childrens ibuprofen	IBUPROFEN	Rite Aid Corporation	26bccfc1-bc8d-4241-a078-c760048951c9	2026-07-24	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen	IBUPROFEN	ATLANTIC BIOLOGICALS CORP.	3ce7549f-e4db-9f89-e063-6294a90a126d	2026-07-10	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Rite Aid Corporation	1da544eb-ed4e-4124-bea3-f827f1322270	2026-05-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	NuCare Pharmaceuticals, Inc.	52d3e633-13a2-cdcd-e063-6394a90ac189	2026-05-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen	IBUPROFEN	Rite Aid Corporation	69ca781a-202e-4579-91e6-f32a22ccc22c	2026-05-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen childrens	IBUPROFEN	Walgreen Company	f67612e8-38f3-4d1c-889b-57995a2f9f66	2026-05-15	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
care one ibuprofen	IBUPROFEN	American Sales Company	d26d2766-6d4c-462b-ae8b-ef8d87acd633	2026-04-16	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Cardinal Health 107, LLC	9291857c-30b3-414b-99e1-9c127e72c0d4	2026-04-16	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen childrens	IBUPROFEN	HyVee Inc	55f8def6-f7de-4b3e-a92a-5cd9e68a46a1	2026-04-15	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
CHILDRENS Ibuprofen	IBUPROFEN	Kesin Pharma Corporation	436c0126-4ff3-c082-e063-6294a90a3d72	2026-04-13	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen childrens	IBUPROFEN	HyVee Inc	3d8497c6-1c46-4248-b75c-b086591529cc	2026-04-10	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen	IBUPROFEN	CVS Pharmacy	ef204cc0-4009-4dd0-83e2-2b5ad6f98409	2026-02-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
equate ibuprofen childrens	IBUPROFEN	Wal-Mart Stores Inc	7817923f-4c21-4943-a7e2-dad4e2915fc4	2026-02-23	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen	IBUPROFEN	HyVee Inc	c20a9bc5-e481-4fb2-ad10-d01e83e43ca0	2026-02-21	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen Childrens	IBUPROFEN	Major Pharmaceuticals	9d56e64d-7860-4fd1-88d2-c537e50079d8	2026-02-13	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
childrens ibuprofen	IBUPROFEN	HyVee Inc	d522a3ac-dd43-4faa-b3f8-69313be1c829	2026-02-11	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen	IBUPROFEN	Major Pharmaceuticals	847758ed-66fc-4db9-8fdb-78f3c3291a03	2026-01-26	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
good sense ibuprofen childrens	IBUPROFEN	Preferred Pharmaceuticals Inc.	7ac61180-d668-4eec-b04f-d14f7b552a4d	2025-12-23	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
topcare childrens ibuprofen	IBUPROFEN	Topco Associates LLC	d1bb68a6-3a29-4a4e-b4e9-413cc8d16191	2025-12-12	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Preferred Pharmaceuticals Inc.	a1a5a9c7-c727-4e41-a8f0-2982f796a3ca	2025-09-29	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937

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
41520-660-26	41520066026	1 BOTTLE in 1 CARTON (41520-660-26) > 118 mL in 1 BOTTLE	1 bottle	2004-05-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
American Sales Company Children's Ibuprofen Oral Suspension Drug Facts	American Sales Company	2019-01-09	HUMAN OTC DRUG LABEL	8