Application 020516

Type: NDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHILDREN'S MOTRIN	IBUPROFEN	SUSPENSION;ORAL	100MG/5ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020516-001	CHILDREN'S MOTRIN	IBUPROFEN	100MG/5ML	SUSPENSION / ORAL		RLD, RS	1995-06-16
N020516-002	MOTRIN IB	IBUPROFEN	200MG/10ML	SUSPENSION / ORAL		RLD, RS	2026-07-22

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 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020516-002	MOTRIN IB	200MG/10ML	SUSPENSION / ORAL	RLD, RS	2026-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020516-002	MOTRIN IB	200MG/10ML	SUSPENSION / ORAL	RLD, RS	2026-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020516-001	CHILDREN'S MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD, RS	1995-06-16	`3bdfa0b2c4d7…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Motrin	IBUPROFEN	Kenvue Brands LLC	4f664479-f68c-464a-956d-25bb9f39c4cc	2024-11-08	Warnings	Exact identifier application applno (NDA): 020516 application number: NDA020516 ndc (product): 50580-603
Childrens Motrin	IBUPROFEN	Kenvue Brands LLC	152189e5-391c-42d3-a03b-c8364e2de6bf	2024-11-08	Warnings	Exact identifier application applno (NDA): 020516 application number: NDA020516 ndc (product): 50580-604
Childrens Motrin	IBUPROFEN	Kenvue Brands LLC	9e1cdef7-921f-4163-869c-6c062e31c5bb	2024-11-01	Warnings	Exact identifier application applno (NDA): 020516 application number: NDA020516 ndc (product): 50580-184
Childrens MOTRIN	IBUPROFEN	Kenvue Brands LLC	f2609308-17bf-4bcb-84b2-d17f3fd35958	2024-11-01	Warnings	Exact identifier application applno (NDA): 020516 application number: NDA020516 ndc (product): 50580-601

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44237-041	Childrens Novex Ibuprofen	Ibuprofen	Herbion Pakistan (Pvt.) Ltd	NDA	Current
50580-184	Childrens Motrin	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-184	Childrens Motrin	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-184	Childrens Motrin	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-184	Childrens Motrin	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-184	Childrens Motrin	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-601	Childrens MOTRIN	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-601	Childrens MOTRIN	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-601	Childrens MOTRIN	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-601	Childrens MOTRIN	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-601	Childrens MOTRIN	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-603	Childrens Motrin	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-603	Childrens Motrin	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-603	Childrens Motrin	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-604	Childrens Motrin	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-604	Childrens Motrin	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-604	Childrens Motrin	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
78307-100	Childrens Novufen Ibuprofen	Ibuprofen	NOVUGEN PHARMA LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67994	SUPPL	2021-06-30
67827	SUPPL	2021-06-16
56811	SUPPL	2018-12-19
56613	SUPPL	2018-12-03
47607	SUPPL	2017-03-20
47569	SUPPL	2017-03-16
34743	SUPPL	2016-06-22
25083	SUPPL	2016-06-21
12664	SUPPL	2015-04-21
2642	SUPPL	2015-04-17
34742	SUPPL	2014-12-19
2641	SUPPL	2014-12-12
25082	SUPPL	2011-12-08
25081	SUPPL	2010-10-22
2640	SUPPL	2009-05-06
2639	SUPPL	2006-06-28
2638	SUPPL	2005-12-15
2637	SUPPL	2005-02-09
2636	SUPPL	2003-12-23
2635	SUPPL	2003-10-31
20691	SUPPL	1999-09-13
12663	SUPPL	1999-09-13
2634	SUPPL	1999-09-13