Application 020601
- Type
- NDA
- Sponsor
- J AND J CONSUMER INC
Application Products#
| 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 |
Orange Book products#
| 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.
| 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals, Inc. | 3520deb7-5e45-3d0f-e063-6394a90ab44b | 2025-05-14 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| profen ib | IBUPROFEN | Publix Super Markets Inc | 51fbfd25-3c4d-4de1-8fa2-e5b4b24022f2 | 2025-05-13 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | ATLANTIC BIOLOGICALS CORP. | 230914e6-fe0c-45be-8b2e-e066c71d004c | 2025-05-12 | Warnings | IBUPROFEN |
| good sense ibuprofen childrens | IBUPROFEN | L. Perrigo Company | b8e3ad4f-3212-4674-bcdf-a60a6b23d7bb | 2025-05-12 | Warnings | IBUPROFEN |
| Childrens Ibuprofen | IBUPROFEN | Meijer Distribution Inc | 3b15dc44-ae1d-43c6-b6c5-05fa31beb554 | 2025-05-12 | Warnings | IBUPROFEN |
| Up and Up childrens ibuprofen | IBUPROFEN | Target Corporation | 28911692-882b-4e30-ba1d-5c10f847be80 | 2025-05-12 | Warnings | IBUPROFEN |
| Equaline Ibuprofen | IBUPROFEN | United Natural Foods, Inc. dba UNFI | c611afc0-5cde-4f01-908a-de52cb61ab02 | 2025-05-08 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | AAFES/Your Military Exchanges | 773b0230-a3a3-44e0-a22b-d143796ca365 | 2025-05-08 | Warnings | IBUPROFEN |
| Equaline ibuprofen childrens | IBUPROFEN | United Natural Foods, Inc. dba UNFI | 811d4360-7468-4ef8-a60e-6e9a6e169de0 | 2025-05-08 | Warnings | IBUPROFEN |
| Good Sense Childrens Ibuprofen | IBUPROFEN | L. Perrigo Company | a8fc1b0c-dd69-4567-8eea-de4d9b0c7740 | 2025-05-07 | Warnings | IBUPROFEN |
| foster and thrive childrens ibuprofen ib | IBUPROFEN | Strategic Sourcing Services LLC | 37adf659-9a92-428b-ac99-5718f242a4e9 | 2025-05-07 | Warnings | IBUPROFEN |
| up and up ibuprofen | IBUPROFEN | Target Corporation | 6e0330ac-a111-4574-9197-d7aab33b8608 | 2025-05-07 | Warnings | IBUPROFEN |
| ibuprofen | IBUPROFEN | Meijer Distribution Inc | 66b19ed1-6cf9-4705-82cd-02f23c6379e7 | 2025-05-06 | Warnings | IBUPROFEN |
| equaline ibuprofen childrens | IBUPROFEN | United Natural Foods, Inc. dba UNFI | 835c3bc8-fb55-4b7e-98ad-3d84d089c8cb | 2025-05-06 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 34673d3b-41cd-f4c9-e063-6394a90a8510 | 2025-05-05 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Aphena Pharma Solutions - Tennessee, LLC | 3467b45b-c432-2923-e063-6394a90a1044 | 2025-05-05 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| ibuprofen | IBUPROFEN | Major Pharmaceuticals | b4962985-47e6-4389-874f-76742b086e2f | 2025-05-03 | Warnings | IBUPROFEN |
| Topcare Infants Ibuprofen | IBUPROFEN | Topco Associates LLC | 00d33273-e8c7-4d40-8e6f-a980f746fff2 | 2025-05-03 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 3732defa-67c2-4b84-8a84-4bbc27b6cb24 | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 689dbbe8-4f85-48fe-8efc-fda81b60d37f | 2025-05-01 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.