Application 020601

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	TABLET, CHEWABLE;ORAL	50MG	Yes	No
003	JUNIOR STRENGTH MOTRIN	IBUPROFEN	TABLET, CHEWABLE;ORAL	100MG	Yes	No

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
N020601-001	CHILDREN'S MOTRIN	IBUPROFEN	50MG	TABLET, CHEWABLE / ORAL		RLD	1996-11-15
N020601-003	JUNIOR STRENGTH MOTRIN	IBUPROFEN	100MG	TABLET, CHEWABLE / ORAL		RLD	1996-11-15

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 · 86 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	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020601-001	CHILDREN'S MOTRIN	50MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020601-003	JUNIOR STRENGTH MOTRIN	100MG	TABLET, CHEWABLE / ORAL	RLD	1996-11-15	`74a2ff9319b5…`

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 46 · 917 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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

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
55883	SUPPL	2018-10-11
55869	SUPPL	2018-10-11
48397	SUPPL	2017-05-17
48391	SUPPL	2017-05-17
2847	SUPPL	2010-10-20
2846	SUPPL	2009-05-04
25294	SUPPL	2006-05-16
2845	SUPPL	2006-03-01
41470	SUPPL	1999-09-13
34940	SUPPL	1999-09-13
25293	SUPPL	1999-09-13