Application 019833

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	CHILDREN'S ADVIL	IBUPROFEN	SUSPENSION;ORAL	100MG/5ML	No	No

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
N019833-002	CHILDREN'S ADVIL	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1989-09-19

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	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019833-002	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1989-09-19	`f41ea6bd6efb…`

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 25 of 47 · 939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	7b2f7a68-8f5e-a340-e053-2991aa0a5aeb	2025-07-01	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	8fecb3a8-d288-cacf-e053-2a95a90ae238	2025-07-01	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	8fed1f86-49a0-4747-e053-2a95a90a42b8	2025-07-01	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Chain Drug Consortium, LLC	f0f01b97-e52c-4077-a4c6-c59736f4c171	2025-06-30	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	388e68dc-1822-f375-e063-6294a90a3d41	2025-06-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
JUNIOR STRENGTH ADVIL	IBUPROFEN	Haleon US Holdings LLC	07d4c400-b182-92f7-7574-9e0e94c39cce	2025-06-27	Warnings	Name fallback generic name: IBUPROFEN
leader Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	009dde4c-d944-4206-8c9f-35bc8fd92715	2025-06-26	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen Childrens	IBUPROFEN	Kroger Company	47a3b118-614d-405d-b80e-31f0b354c430	2025-06-25	Warnings	Name fallback generic name: IBUPROFEN
Good Neighbor Pharmacy Childrens Ibuprofen	IBUPROFEN	Amerisource Bergen	40a6a842-a85b-4e24-8786-32ecd74f6870	2025-06-25	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	Safeway	1b7854d6-32b9-4410-bb40-0f02e46c7966	2025-06-24	Warnings	Name fallback generic name: IBUPROFEN
Motrin IB	IBUPROFEN	Morning Star OTC	e69f00c4-b8ec-4a83-9eea-8cb2835ad776	2025-06-19	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	AAA Pharmaceutical, Inc.	1e686091-6456-36c8-e063-6294a90a3866	2025-06-17	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	AAA Pharmaceutical, Inc.	78cf5df8-392b-4a4e-b424-af765a6defdf	2025-06-17	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	FSA STORE INC.	ec6b015d-e72e-89c4-e053-2a95a90af81c	2025-06-17	Warnings	Name fallback generic name: IBUPROFEN
Topcare Ibuprofen	IBUPROFEN	Topco Associates LLC	8be375b0-c729-49de-abc5-2e7d37144b89	2025-06-16	Warnings	Name fallback generic name: IBUPROFEN
good neighbor pharmacy ibuprofen	IBUPROFEN	Amerisource Bergen	08d9477e-3033-4b74-8f81-934f39e37e55	2025-06-16	Warnings	Name fallback generic name: IBUPROFEN
equaline ibuprofen	IBUPROFEN	United Natural Foods, Inc. dba UNFI	9bf3546a-9f94-47b5-9b01-aed93e69d5aa	2025-06-16	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	CVS Pharmacy	e655bd64-dd82-46d8-87cc-2674beaffe20	2025-06-16	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Major Pharmaceuticals	03993008-7bd2-465f-b5a9-1cbc3c1fff02	2025-06-16	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Publix Super Markets Inc	032decc5-9f7a-4f12-8ca4-a95a79a426c6	2025-06-16	Warnings	Name fallback generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
41046	SUPPL	2003-09-11