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| 002 | MOTRIN | IBUPROFEN | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | MOTRIN | IBUPROFEN | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | MOTRIN | IBUPROFEN | TABLET;ORAL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | MOTRIN | IBUPROFEN | TABLET;ORAL | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N017463-002 | MOTRIN | IBUPROFEN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017463-003 | MOTRIN | IBUPROFEN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017463-004 | MOTRIN | IBUPROFEN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017463-005 | MOTRIN | IBUPROFEN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 |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 |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | Safeway, Inc. | 57f06daf-690d-44a7-95a5-468732949750 | 2026-08-19 | Warnings | IBUPROFEN |
| ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | 59554a62-3a9a-c0f3-e063-6294a90ad3fd | 2026-08-18 | Warnings | IBUPROFEN |
| CHILDRENS IBUPROFEN | IBUPROFEN | Amazon.com Services LLC | 0865fe8a-df81-4ae4-8bed-29a022ba164f | 2026-08-17 | Warnings | IBUPROFEN |
| CHILDRENS IBUPROFEN | IBUPROFEN | Amazon.com Services LLC | 5ba08c30-7eb9-433b-b763-9288f4dd1012 | 2026-08-12 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | AiPing Pharmaceutical, Inc. | 3e131710-2579-446e-8076-f602ecea813f | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| INFANTS IBUPROFEN | IBUPROFEN | Amazon.com Services LLC | 8588617a-d4b8-4ab5-8b87-30e6f1121cc3 | 2026-08-10 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Shield Pharmaceuticals Corp | 22102461-0196-4ef0-aef4-66997d74d118 | 2026-08-10 | Warnings | IBUPROFEN |
| Ibuprofen minis | IBUPROFEN | Walgreens | 6d1d131d-0741-4a75-8383-9322f4f3faab | 2026-08-06 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Shield Pharmaceuticals Corp | 216e5600-56b4-44b0-88b7-69adfb245802 | 2026-08-06 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | COSTCO WHOLESALE CORPORATION | 4b8ad98e-de76-4f49-3b89-01e9dd5cde16 | 2026-08-06 | Warnings | IBUPROFEN |
| Dye Free Ibuprofen | IBUPROFEN | Walgreen Company | d3d093f9-207a-40d4-a7be-c6b5a544a0a7 | 2026-08-06 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | P & L Development, LLC | 159b68b7-54e5-4f83-b632-f49e7b4b14a5 | 2026-08-05 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Walgreen Company | c118b290-f821-4e73-906e-8a93edaf34e4 | 2026-08-05 | Warnings | IBUPROFEN |
| Dye Free Ibuprofen | IBUPROFEN | Walgreen Company | 8944a0e8-2928-4494-915f-d1e0a6d4bf5c | 2026-08-04 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | REMEDYREPACK INC. | 560e4e05-21e0-4b2a-ab2f-872b5dbb3901 | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Chain Drug Marketing Association, Inc. | 733d0b21-c177-4c60-9243-2f1e7cb5854a | 2026-08-04 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Pioneer Life Sciences, LLC | 8abd74a4-ad33-4c10-b677-acb469f815e6 | 2026-08-03 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Pioneer Life Sciences, LLC | 291602fa-8ebe-4200-bba7-9798c90f8a50 | 2026-08-03 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | NUVICARE LLC | b063d2dc-d579-46e7-8cfc-1596c803c7f9 | 2026-08-03 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | NUVICARE LLC | 7905edc1-2a45-4adc-a7bc-42b1ddb6ba59 | 2026-08-03 | Warnings | IBUPROFEN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.