Application 020589

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020589-001	CHILDREN'S ADVIL	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1996-06-27
N020589-002	CHILDREN'S ADVIL-FLAVORED	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL			1997-11-07

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020589-001	CHILDREN'S ADVIL	100MG/5ML	SUSPENSION / ORAL	1996-06-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020589-002	CHILDREN'S ADVIL-FLAVORED	100MG/5ML	SUSPENSION / ORAL	1997-11-07	`782e0a99824c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020589-002	10238640	2024-05-25	Drug product	2019-04-24	`cb3db0bc1861…`

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHILDRENS ADVIL	IBUPROFEN	Haleon US Holdings LLC	3079d932-afb2-94fe-f4ba-a3d8b5198fce	2024-02-08	Warnings	Exact identifier application applno (NDA): 020589 application number: NDA020589 ndc (product): 0573-0290 ndc (product): 0573-0170 ndc (product): 0573-0174 ndc (product): 0573-0171 ndc (product): 0573-0207 ndc (product): 0573-0232
CHILDRENS ADVIL	IBUPROFEN	Haleon US Holdings LLC	4eba2795-e826-480d-afdc-d62004e95f36	2024-02-08	Warnings	Exact identifier application applno (NDA): 020589 application number: NDA020589 ndc (product): 0573-1174

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0573-0170	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0170	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0170	CHILDRENS ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0170	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0170	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0171	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0171	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0171	CHILDRENS ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0171	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0171	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0174	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0174	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0174	CHILDRENS ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0174	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0174	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0207	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0207	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0207	CHILDRENS ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0207	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0207	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0232	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0232	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0232	CHILDRENS ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0232	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0232	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0290	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0290	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0290	CHILDRENS ADVIL	ibuprofen	Wyeth Consumer Healthcare LLC	NDA	Current
0573-0290	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-0290	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0573-1174	CHILDRENS ADVIL	ibuprofen	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85820	SUPPL	2026-05-04
72133	SUPPL	2022-09-21
72119	SUPPL	2022-09-21
55368	SUPPL	2018-08-30
48843	SUPPL	2017-06-27
48798	SUPPL	2017-06-22
47702	SUPPL	2017-03-24
47666	SUPPL	2017-03-24
12785	SUPPL	2014-01-13
25250	SUPPL	2013-12-24
25249	SUPPL	2010-09-07
25248	SUPPL	2009-05-26
2801	SUPPL	2008-06-16
25247	SUPPL	2005-12-15
34899	SUPPL	2005-03-23
2800	SUPPL	2005-03-23
12784	SUPPL	2003-04-25