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 14 of 47 · 939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ibuprofen infants	IBUPROFEN	HyVee Inc	e8fcaf17-234a-4d64-b621-9ca505884b0a	2026-01-12	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	d3b8d35a-10b5-a31c-8ced-eeb100c0fd7c	2026-01-12	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Meijer Distribution Inc	c0c64ba5-b6b0-4221-9e44-110d92c93782	2026-01-12	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Coupler LLC	4831785a-cde2-79a2-e063-6294a90a9a40	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	L.N.K. International, Inc.	c93da67f-f42e-4baa-976b-73c71ba6dd71	2026-01-12	Warnings	Name fallback generic name: IBUPROFEN
GOOD SENSE CHILDRENS IBUPROFEN	IBUPROFEN	L. Perrigo Company	cd06ffc5-4921-4b2d-88ea-939fa4daf59c	2026-01-09	Warnings	Name fallback generic name: IBUPROFEN
Xpect Ibuprofen	IBUPROFEN	Cintas Corporation	976ba88a-6428-40d1-a2fd-eac64963ba1d	2026-01-08	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Strides Pharma Inc	69b208ff-83f5-40d1-a2ff-d54b390e46e4	2026-01-08	Warnings	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	CVS Pharmacy	ace493e6-91bc-41aa-8e5c-5bc14981de91	2026-01-06	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen minis	IBUPROFEN	Safeway, Inc.	22927a12-6837-4d57-8e60-043000f2f208	2026-01-05	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	DOLGENCORP, LLC	37ccb303-c70e-48b3-a8a3-2b0097cf8f88	2026-01-05	Warnings	Name fallback generic name: IBUPROFEN
DG Health Ibuprofen	IBUPROFEN	Dolgencorp Inc	1dd4ffc5-3132-419b-8e70-78a7bb71da62	2026-01-02	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	2f12a20c-4293-d18a-e063-6294a90a3afc	2026-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	c20f1f4d-59b3-6bbe-e053-2a95a90abaf1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	ab313564-27dc-0297-e053-2a95a90a6690	2026-01-01	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	dac07d8f-6b6f-20ab-e053-2a95a90af3ba	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Northwind Health Company, LLC	da6c72ad-009f-3d7f-e053-2995a90a68e9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Northwind Health Company, LLC	da6c2802-5d15-dbcb-e053-2a95a90a2561	2026-01-01	Warnings	Name fallback generic name: IBUPROFEN
Motrin IB	IBUPROFEN	Savings Distributors LLC	56846774-8413-c306-e063-6394a90a2be8	2026-01-01	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES, INC	e0a8315a-80a5-4be3-aad1-3d01f00df494	2025-12-29	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