Childrens Ibuprofen

Product NDC: 55154-1577
11-digit product format: 551541577
Labeler code: 55154
Product ID: 55154-1577_fbdc0403-6c4d-47af-a5c8-f3e4811712aa
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA074937
Marketing category: ANDA
Marketing start: 2004-04-13
Substance: IBUPROFEN
Active strength: 100 mg/5mL
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A074937-001	CHILDREN'S IBUPROFEN	100MG/5ML	SUSPENSION / ORAL	1998-12-22	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Childrens Ibuprofen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBUPROFEN	100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WK2XYI10QM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197803	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9291857c-30b3-414b-99e1-9c127e72c0d4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55154-1577-5	Childrens Ibuprofen	5 in 1 BAG	SUSPENSION	5		11
55154-1577-5	Childrens Ibuprofen	5 mL in 1 CUP, UNIT-DOSE	SUSPENSION	5		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2
butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2
corn syrup	INACTIVE INGREDIENT	9G5L16BK6N	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2
D&C red NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2
FD&C yellow NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2
sorbitol	INACTIVE INGREDIENT	506T60A25R	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2
water	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-1577	CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH 107, LLC]	9	Current NDC, Legacy NDC, 2 package rows	20250313_9291857c-30b3-414b-99e1-9c127e72c0d4.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 · 84 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ibuprofen	IBUPROFEN	NuCare Pharmaceuticals,Inc.	59554a62-3a9a-c0f3-e063-6294a90ad3fd	2026-08-18	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
CHILDRENS IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	0865fe8a-df81-4ae4-8bed-29a022ba164f	2026-08-17	Warnings	Exact identifier application applno (ANDA): 074937 application number: ANDA074937
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 ndc (product): 55154-1577
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

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197803	ibuprofen 100 MG in 5 mL Oral Suspension	PSN	9291857c-30b3-414b-99e1-9c127e72c0d4	11
197803	ibuprofen 20 MG/ML Oral Suspension	SCD	9291857c-30b3-414b-99e1-9c127e72c0d4	11
197803	ibuprofen 100 MG per 5 ML Oral Suspension	SY	9291857c-30b3-414b-99e1-9c127e72c0d4	11
197803	ibuprofen 200 MG per 10 ML Oral Suspension	SY	9291857c-30b3-414b-99e1-9c127e72c0d4	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-1577-5	55154157705	5 CUP, UNIT-DOSE in 1 BAG (55154-1577-5) / 5 mL in 1 CUP, UNIT-DOSE	2004-04-13	0000-00-00	No	No	Current