Application 017463
- Type
- NDA
- Sponsor
- MCNEIL CONSUMER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | MOTRIN | IBUPROFEN | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | MOTRIN | IBUPROFEN | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | MOTRIN | IBUPROFEN | TABLET;ORAL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | MOTRIN | IBUPROFEN | TABLET;ORAL | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017463-002 | MOTRIN | IBUPROFEN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017463-003 | MOTRIN | IBUPROFEN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017463-004 | MOTRIN | IBUPROFEN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017463-005 | MOTRIN | IBUPROFEN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | 5bbf6a4d5a75… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| childrens ibuprofen | IBUPROFEN | Meijer Distribution Inc | cfe27d2a-b602-4b3e-bdcb-14fed4a236ca | 2025-07-17 | Warnings | IBUPROFEN |
| Dg Health Ibuprofen | IBUPROFEN | Dolgencorp, LLC | 9022e393-084e-499b-ac84-f35360d79592 | 2025-07-17 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Demoulas Super Markets, Inc | 39802e26-1028-d2fe-e063-6394a90a24c7 | 2025-07-16 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | AMERIFOODS TRADING COMPANY | f6dc62db-f728-66fc-e053-6394a90a96b3 | 2025-07-15 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | MARC GLASSMAN, INC. | 7f366669-9d31-46c7-932d-02fa64b11f30 | 2025-07-15 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Marc Glassman, Inc. | 9714e804-fadb-103d-e053-2a95a90ad765 | 2025-07-15 | Warnings | IBUPROFEN |
| IBUPROFEN | IBUPROFEN | AMERIFOODS TRADING COMPANY | f6dc2a73-046b-6b93-e053-6294a90ab295 | 2025-07-15 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | MARC GLASSMAN, INC. | 9714de6b-068b-d6b9-e053-2995a90a3b27 | 2025-07-15 | Warnings | IBUPROFEN |
| Childrens Ibuprofen | IBUPROFEN | Kroger Company | 91da5b64-db7f-4954-89e8-977b31247f9c | 2025-07-11 | Warnings | IBUPROFEN |
| Childrens Ibuprofen | IBUPROFEN | Rite Aid Corporation | 70eb40b8-5862-4eb9-adc8-8a9d6bca7c7d | 2025-07-11 | Warnings | IBUPROFEN |
| Childrens Ibuprofen | IBUPROFEN | Safeway | 0fe94b11-f7c9-4e32-976f-e5f11d01bd64 | 2025-07-09 | Warnings | IBUPROFEN |
| Foster and Thrive Ibuprofen | IBUPROFEN | Strategic Sourcing Services LLC | cf330b44-2d69-4f9f-99eb-2caa80aca873 | 2025-07-08 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Sun Pharmaceutical Industries, Inc. | 6cf3328b-da8f-4f6b-8237-16a4d6b9c833 | 2025-07-07 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Sun Pharmaceutical Industries, Inc. | f4dad3d6-1366-4bdf-99eb-370ab74a6b9e | 2025-07-07 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Sun Pharmaceutical Industries, Inc. | 398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e | 2025-07-07 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| IBU | IBUPROFEN | Dr. Reddy's Laboratories Limited | 24731405-219c-79b4-ecf0-7d5fbfda94ba | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| ibuprofen 200 | IBUPROFEN | Walgreen Company | 49a3d51d-55d1-4b80-ab7b-35c27a937cb9 | 2025-07-02 | Warnings | IBUPROFEN |
| Topcare ibuprofen | IBUPROFEN | Topco Associates LLC | 479a0c97-dbd9-47ad-9910-9dd4edf5136f | 2025-07-02 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | CVS Pharmacy | e241ca5f-04bd-4bc9-bd0c-ca22841c4a3c | 2025-07-01 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | United Natural Foods, Inc. dba UNFI | 37eaa3b1-98e9-4fcf-ae74-153bfc35551f | 2025-07-01 | Warnings | IBUPROFEN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.