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 26 of 47 · 939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
care one ibuprofen childrens	IBUPROFEN	American Sales Company	c56511fd-ff2e-40f6-91e6-fe04e563fafd	2025-06-13	Warnings	Name fallback generic name: IBUPROFEN
profen IB childrens	IBUPROFEN	Publix Super Markets Inc	1af04e26-e32c-4c1c-bbda-2c78f2030ac6	2025-06-13	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	TIME CAP LABORATORIES,INC	f58d35f9-e44b-417b-98ce-0766b537cd2f	2025-06-12	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Marc Glassman, Inc.	47434f23-5ac9-4cb4-a963-7c8bf9e06361	2025-06-11	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Marc Glassman, Inc.	3b0e4ccc-cc0b-42fb-9163-7560740d9592	2025-06-11	Warnings	Name fallback generic name: IBUPROFEN
Topcare Childrens Ibuprofen	IBUPROFEN	Topco Associates LLC	45255d2f-c592-4750-abb5-21647d4fbd51	2025-06-10	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen childrens	IBUPROFEN	Meijer Distribution Inc	625226ef-d55b-4f93-ad1e-4fe2b07d4133	2025-06-10	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Trifecta Pharmaceuticals USA LLC	37299475-e2f3-de26-e063-6394a90ad62d	2025-06-09	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NCS HealthCare of KY, LLC dba Vangard Labs	ab11e142-9e11-4ce4-9671-7e4fe53ffe92	2025-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	NCS HealthCare of KY, LLC dba Vangard Labs	f1842893-7a34-4f77-8231-55fb0c98b22b	2025-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	WALGREENS	7653b33c-7489-10db-e053-2991aa0ab508	2025-06-06	Warnings	Name fallback generic name: IBUPROFEN
AMAZON BASIC CARE IBUPROFEN	IBUPROFEN	Amazon.com Services LLC	113dd693-6abe-1a0f-e063-6394a90a167e	2025-06-06	Warnings	Name fallback generic name: IBUPROFEN
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	9eafb61a-43bc-4845-b45a-72c7d5ac424e	2025-06-05	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen 200	IBUPROFEN	Walgreen Company	62e8db95-aaef-4b0e-841e-64a0339f3190	2025-06-04	Warnings	Name fallback generic name: IBUPROFEN
Good Sense Ibuprofen Childrens	IBUPROFEN	L. Perrigo Company	321d6b3a-3dff-4334-b6ee-6ac801b9907c	2025-06-03	Warnings	Name fallback generic name: IBUPROFEN
Leader Childrens Ibuprofen	IBUPROFEN	Cardinal Health 110, LLC. dba Leader	2b0c3bb1-7667-403f-99e6-13c83755b1b5	2025-06-03	Warnings	Name fallback generic name: IBUPROFEN
care one ibuprofen	IBUPROFEN	American Sales Company	006adf23-21ab-4a4e-aae9-c4e587777165	2025-06-03	Warnings	Name fallback generic name: IBUPROFEN
up and up childrens ibuprofen	IBUPROFEN	Target Corporation	834b7f5e-e636-4537-9bae-2d309fcc8eb3	2025-06-02	Warnings	Name fallback generic name: IBUPROFEN
equate ibuprofen childrens	IBUPROFEN	Wal-Mart Stores Inc	ed9ee7b5-2d9a-4aaf-a245-aa13fcc6365a	2025-05-23	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Bryant Ranch Prepack	92878aad-0bf9-4303-a1f8-4b9b23848a71	2025-05-21	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