Application 019842

Type: NDA
Sponsor: MCNEIL CONSUMER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOTRIN	IBUPROFEN	SUSPENSION;ORAL	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019842-001	MOTRIN	IBUPROFEN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL		RLD	1989-09-19

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 · 43 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	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019842-001	MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD	1989-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019842-001	MOTRIN	100MG/5ML	SUSPENSION / ORAL	RLD	1989-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SUSPENSION / ORAL	RLD	1989-09-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019842-001	MOTRIN	100MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SUSPENSION / ORAL	RLD	1989-09-19	`f41ea6bd6efb…`

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 42 of 46 · 917 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	Care One (American Sales Company)	016299ef-ad40-46fd-acfc-e74ffee3d9b4	2022-11-21	Warnings	Name fallback generic name: IBUPROFEN
signature care childrens ibuprofen	IBUPROFEN	Safeway	c30fbb8f-a293-4f6e-9495-11402548fe2d	2022-11-15	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	7f510feb-023c-4974-af6d-3e7a30cef362	2022-11-07	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8de40427-1be3-4a86-bc4c-9659ebaa203f	2022-11-07	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	9e9fb921-6b6a-422e-95b6-41d6b9047b80	2022-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
DG Health childrens ibuprofen	IBUPROFEN	Dolgencorp, LLC	0fd6fcca-cbfe-48af-80dd-2607b5d51b53	2022-10-13	Warnings	Name fallback generic name: IBUPROFEN
Circle K Ibuprofen	IBUPROFEN	Lil Drug Store Products, Inc	791a7375-34b2-449b-9284-3c49a2704619	2022-10-11	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PharmPak, Inc.	b493bf76-1e8b-4e72-bef6-aca4efc69cbe	2022-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PharmPak, Inc.	4d95bccd-8280-4d03-a574-927669c7cda0	2022-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	PharmPak, Inc.	bb6d0547-c113-42f9-8bf2-c227a55ab758	2022-10-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Circle K Ibuprofen	IBUPROFEN	Lil Drug Store Products, Inc	805d9d80-7de7-49d9-afdb-3a645059fe35	2022-09-21	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	e1b49257-d226-457f-8f2d-9a757a65bbcb	2022-09-06	Warnings	Name fallback generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension	IBUPROFEN	Pharmaceutical Associates, Inc.	7a6832f2-2d80-483c-bde3-e6cacb7c318a	2022-08-31	Warnings	Name fallback generic name: IBUPROFEN
betr pain relief	IBUPROFEN	Live Betr LLC	1b709dce-5c71-45e6-b516-d510a0a8c25d	2022-08-24	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	DOLGENCORP, INC.	df321783-73cb-55bf-e053-2a95a90a4ce2	2022-07-07	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	b7565aac-a928-4116-b9af-cf636da4537c	2022-07-01	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	CARDINAL HEALTH	dfbbde4f-633d-6d57-e053-2a95a90ad82f	2022-05-24	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Aurohealth LLC	7779c369-50bf-4cde-9015-ff3fb35e128e	2022-05-16	Warnings	Name fallback generic name: IBUPROFEN
Ibuprofen	IBUPROFEN	Proficient Rx LP	d2c7f045-e70c-4e2b-b2e0-d81a271d0a04	2022-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: IBUPROFEN
Motrin IB	IBUPROFEN	Jones Healthcare Group - Packaging Services, Inc	6419cc78-27d4-7713-e053-2a91aa0a5a10	2022-04-29	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
34014	SUPPL	2007-09-11
19290	SUPPL	2007-09-11
20391	SUPPL	2006-05-08
19289	SUPPL	2006-01-30
11765	SUPPL	2006-01-25