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 | Advanced Rx of Tennessee, LLC | 1ef5693b-d00a-28fb-e063-6294a90a7ede | 2024-11-21 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Ibuprofen | IBUPROFEN | TIME CAP LABORATORIES, INC | ec3e8443-d742-4c25-8516-f0df4ebfccdc | 2024-11-21 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| dg health ibuprofen | IBUPROFEN | Dolgencorp, LLC | fd27d4e1-8edf-4bc3-a593-6be5c3345ed0 | 2024-11-13 | Warnings | IBUPROFEN |
| Childrens Motrin | IBUPROFEN | Kenvue Brands LLC | 4f664479-f68c-464a-956d-25bb9f39c4cc | 2024-11-08 | Warnings | IBUPROFEN |
| Childrens Motrin | IBUPROFEN | Kenvue Brands LLC | 152189e5-391c-42d3-a03b-c8364e2de6bf | 2024-11-08 | Warnings | IBUPROFEN |
| good sense ibuprofen | IBUPROFEN | A-S Medication Solutions | 9ac095d2-ba19-4da1-acc9-85f7b4ae304d | 2024-11-04 | Warnings | IBUPROFEN |
| Childrens Motrin | IBUPROFEN | Kenvue Brands LLC | 9e1cdef7-921f-4163-869c-6c062e31c5bb | 2024-11-01 | Warnings | IBUPROFEN |
| Childrens MOTRIN | IBUPROFEN | Kenvue Brands LLC | f2609308-17bf-4bcb-84b2-d17f3fd35958 | 2024-11-01 | Warnings | IBUPROFEN |
| GOOD REMEDIES ibuprofen 200 mg | IBUPROFEN | Strive Pharmaceuticals Inc. | 24fb3741-65e0-898d-e063-6394a90af569 | 2024-10-31 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 7650f84b-92f2-4065-8ef2-f5de5bd7002b | 2024-10-29 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 1361b6d6-0443-460a-8446-41f63a1e28df | 2024-10-28 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Rugby Laboratories, Inc. | 05c4e6c7-bf95-4e05-b7da-7a8778de342b | 2024-10-28 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | BETTER LIVING BRANDS, LLC | eb619068-be71-7569-e053-2a95a90a4a6e | 2024-10-26 | Warnings | IBUPROFEN |
| Ibuprofen Pain Reliever/Fever Reducer | IBUPROFEN | Amneal Pharmaceuticals LLC | 877440fc-3afb-4123-a2e6-5cb48c74413c | 2024-10-25 | Warnings | IBUPROFEN |
| Ibuprofen Pain Reliever/Fever Reducer | IBUPROFEN | Amneal Pharmaceuticals LLC | 5f27dd3f-c735-417b-95e6-26dc5aae5a7a | 2024-10-25 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 2d0c2d35-c212-4daa-b2c4-b407ca0b16ad | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 2b470e48-c23c-4f5c-916a-d38d8518896b | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| kirkland signature ibuprofen ib | IBUPROFEN | Costco Wholesale Company | 2fee0f32-0bc7-4d98-b5d4-5a7dad1c2a2c | 2024-10-14 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | b87cf806-1635-44d5-a9de-383081cb37d8 | 2024-10-14 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | df0e55d0-617c-4084-984f-ece2f640e715 | 2024-10-11 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.