care one ibuprofen

Product NDC: 41520-660
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	41520-660		D	Discontinued by firm	2026-10-05
excluded package	package	41520-660	41520-660-26	D	Discontinued by firm	2026-10-05
excluded package	package	41520-660	41520-660-28	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
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 · 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	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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 4 of 5 · 81 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEADER CHILDRENS IBUPROFEN	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	913a4bd0-0784-45b4-b05e-3e7c016bbb86	2025-03-03	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
equate ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	2daee8c1-d05e-406b-af65-b81bbbaa244d	2025-03-03	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen	IBUPROFEN	Padagis Israel Pharmaceuticals Ltd	02889717-204c-463b-8506-4c5cf18c77d3	2025-03-03	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Dye Free Childrens Ibuprofen	IBUPROFEN	Precision Dose Inc.	eccee4c6-aa94-468a-aebd-265d7a9efb6d	2025-02-12	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Padagis Israel Pharmaceuticals Ltd	2457c045-0b7c-48f4-9422-11623f13d8f1	2025-01-29	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	Padagis Israel Pharmaceuticals Ltd	efb728f2-fe74-4833-8f0c-710d833abf6e	2025-01-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	7cd838e1-85da-4510-86f0-9d8bc913e810	2025-01-03	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Good Neighbor Pharmacy Childrens Ibuprofen	IBUPROFEN	Amerisource Bergen	b8f43352-f771-4722-b843-f3e29f77c7c0	2025-01-03	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen 100 Dye Free	IBUPROFEN	Walgreen Company	397c84f3-2ffc-41e8-aefb-cc0b46afc7e7	2023-06-06	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Rexall Ibuprofen	IBUPROFEN	Dolgencorp, LLC	d2dc2f71-c0cb-4e6d-85b9-fcf386e207a0	2023-06-06	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Ibuprofen Childrens	IBUPROFEN	Walgreen Company	884f1e7a-37a1-457e-a940-ee8af5434c89	2023-04-13	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
DG Health childrens ibuprofen	IBUPROFEN	Dolgencorp, LLC	0fd6fcca-cbfe-48af-80dd-2607b5d51b53	2022-10-13	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	0dec2df9-ba8b-4bc7-b617-773aa08f9273	2021-12-20	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	b2a14686-6083-46a1-885c-9f7c30e9c647	2021-11-30	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	1204267a-5505-4257-837b-8902b7571347	2021-09-07	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
dg health childrens ibuprofen	IBUPROFEN	Dolgencorp, LLC	ad8475b3-ace1-4a05-b927-3286a8139cb4	2021-05-26	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Childrens Ibuprofen	IBUPROFEN	CVS Pharmacy	60fd517d-608b-473e-8a44-eb9842459997	2020-10-22	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
ibuprofen	IBUPROFEN	Proficient Rx LP	6d84ed87-b643-46e2-96d4-2052f41bd936	2020-02-01	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
childrens ibuprofen	IBUPROFEN	H E B	e7e2b766-6d05-49e2-9e88-72454b857935	2019-12-27	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
Care One ibuprofen childrens	IBUPROFEN	American Sales Company	703869c9-7f12-4556-a2af-8e68942834f2	2018-11-26	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
41520-660-28	41520066028	1 BOTTLE in 1 CARTON (41520-660-28) > 147 mL in 1 BOTTLE	1 bottle	2013-08-03	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