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 44 of 46 · 917 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
infants ibuprofen	IBUPROFEN	H E B	2c67fecb-2e69-44d6-8ab8-3251abae72a6	2021-11-16	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CHAIN DRUG MARKETING ASSOCIATION INC	c13455a3-307a-4fe1-e053-2a95a90adf8e	2021-11-10	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	RITE AID CORPORATION	a7abac4c-7695-cfe8-e053-2a95a90ac1cd	2021-10-30	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen bubblegum	IBUPROFEN	Guardian Drug Company	9cb92af9-a829-4f54-b8f5-4e5cb4f165b7	2021-10-13	Warnings	Name fallback generic name: IBUPROFEN
basic care infants ibuprofen	IBUPROFEN	Amazon.com Services LLC	1b5b96cc-40d4-4fb8-b429-cc1a5076fa77	2021-10-08	Warnings	Name fallback generic name: IBUPROFEN
rexall ibuprofen	IBUPROFEN	Dolgencorp, LLC	869185d5-9f34-4d38-9551-dd0b4fc8557d	2021-09-09	Warnings	Name fallback generic name: IBUPROFEN
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	1204267a-5505-4257-837b-8902b7571347	2021-09-07	Warnings	Name fallback generic name: IBUPROFEN
Migraine Relief	IBUPROFEN	Bionpharma Inc.	662ae0e0-bd44-4db4-8083-fc2e11d49abe	2021-08-24	Warnings	Name fallback generic name: IBUPROFEN
basic care childrens ibuprofen	IBUPROFEN	Amazon.com Services LLC	b17b0aac-55d2-4917-a722-b8587ad643bc	2021-08-13	Warnings	Name fallback generic name: IBUPROFEN
dg health childrens ibuprofen	IBUPROFEN	Dolgencorp, LLC	ad8475b3-ace1-4a05-b927-3286a8139cb4	2021-05-26	Warnings	Name fallback generic name: IBUPROFEN
IBU	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	b0f03994-b744-4d66-95b7-8c86217882bc	2021-05-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
basic care infants ibuprofen	IBUPROFEN	Amazon.com Services LLC	581dca08-a4a4-476a-a7cf-fa0f8630c777	2021-05-04	Warnings	Name fallback generic name: IBUPROFEN
IBUPROFEN	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	77adb094-869c-44b4-8a4e-b739ac9cd701	2021-04-20		Name fallback generic name: IBUPROFEN
IBU	IBUPROFEN	Aphena Pharma Solutions - Tennessee, LLC	3e45f971-b6f7-4ec5-9d8e-1b9127b6c0bd	2021-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
ibuprofen	IBUPROFEN	Proficient Rx LP	924d2dd0-3b7d-42ec-b617-86729dba2b95	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	e23eb275-ce0c-40ec-b809-a48c5e46c7ec	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	8813a8a4-ebbd-4204-88a3-600a92ea9170	2020-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen	IBUPROFEN	CVS Pharmacy	60fd517d-608b-473e-8a44-eb9842459997	2020-10-22	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen IB	IBUPROFEN	WINCO FOODS, LLC	9d78644d-83c7-46d1-8156-0d76acb7c299	2020-09-17	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen IB	IBUPROFEN	WINCO FOODS, LLC	ee867519-227f-44ba-ba8b-2dbefcc9fc67	2020-09-17	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