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 41 of 47 · 939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Ibuprofen 100 Dye Free	IBUPROFEN	Walgreen Company	397c84f3-2ffc-41e8-aefb-cc0b46afc7e7	2023-06-06	Warnings	Name fallback generic name: IBUPROFEN
Rexall Ibuprofen	IBUPROFEN	Dolgencorp, LLC	d2dc2f71-c0cb-4e6d-85b9-fcf386e207a0	2023-06-06	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	e4bb22bb-6df6-4016-a023-0b454df9fb0b	2023-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
basic care ibuprofen	IBUPROFEN	Amazon.com Services LLC	3329f487-675d-440c-b7c5-d17a2b024275	2023-05-31	Warnings	Name fallback generic name: IBUPROFEN
CHILDRENS IBUPROFEN	IBUPROFEN	BluePoint Laboratories	d71acfe2-4643-f50b-e053-2a95a90add8b	2023-05-31	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	7d544d8e-fa76-461f-9417-5f1873912eac	2023-05-15	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Publix Super Markets Inc	2dd98554-e434-4617-b789-6ecce7144988	2023-05-04	Warnings	Name fallback generic name: IBUPROFEN
Equate Ibuprofen	IBUPROFEN	Wal-Mart Stores Inc	153bc4ac-427d-426a-9bb8-665487e4b169	2023-04-27	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	P & L Development, LLC	1889faea-24a3-45ea-92de-8dc76b9ed5b4	2023-04-25	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen Childrens	IBUPROFEN	Walgreen Company	884f1e7a-37a1-457e-a940-ee8af5434c89	2023-04-13	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	RITE AID CORPORATION	de158883-1175-18fc-e053-2995a90a3c96	2023-04-12	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	403ec259-3be1-4e0b-ab7b-fee213b7eabe	2023-04-03	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Proficient Rx LP	4ee828df-873d-4379-9a17-a805d97dfe04	2023-04-01	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	759e5cf4-641f-4b3c-bc06-9ee0b4d010fc	2023-03-16	Warnings	Name fallback generic name: IBUPROFEN
Motrin IB	IBUPROFEN	Navajo Manufacturing Company Inc.	f70c1b68-61c8-b333-e053-6294a90aadaa	2023-03-16	Warnings	Name fallback generic name: IBUPROFEN
Advil Liquigels	IBUPROFEN	Navajo Manufacturing Company Inc.	e2c09216-fd63-4d50-9878-62b36236b2e7	2023-03-15	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	BETTER LIVING BRANDS LLC.	a3fadcc0-97f5-9f9b-e053-2a95a90aeb54	2023-03-15	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Cardinal Health (Leader) 70000	e751cb66-5fa5-4171-b061-da34aa10de6c	2023-03-10	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen minis	IBUPROFEN	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	c3f1b721-2bb0-4297-bfc6-7faaf9ba8419	2023-03-09	Warnings	Name fallback generic name: IBUPROFEN
IBU	IBUPROFEN	Proficient Rx LP	ea6f626d-cda3-46e2-9ac9-4e72204cb726	2023-03-01	Boxed warning, Warnings, Adverse reactions	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