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 | NCS HealthCare of KY, LLC dba Vangard Labs | ab11e142-9e11-4ce4-9671-7e4fe53ffe92 | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Ibuprofen | IBUPROFEN | NCS HealthCare of KY, LLC dba Vangard Labs | f1842893-7a34-4f77-8231-55fb0c98b22b | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| IBUPROFEN | IBUPROFEN | WALGREENS | 7653b33c-7489-10db-e053-2991aa0ab508 | 2025-06-06 | Warnings | IBUPROFEN |
| AMAZON BASIC CARE IBUPROFEN | IBUPROFEN | Amazon.com Services LLC | 113dd693-6abe-1a0f-e063-6394a90a167e | 2025-06-06 | Warnings | IBUPROFEN |
| basic care childrens ibuprofen | IBUPROFEN | Amazon.com Services LLC | 9eafb61a-43bc-4845-b45a-72c7d5ac424e | 2025-06-05 | Warnings | IBUPROFEN |
| Ibuprofen 200 | IBUPROFEN | Walgreen Company | 62e8db95-aaef-4b0e-841e-64a0339f3190 | 2025-06-04 | Warnings | IBUPROFEN |
| Good Sense Ibuprofen Childrens | IBUPROFEN | L. Perrigo Company | 321d6b3a-3dff-4334-b6ee-6ac801b9907c | 2025-06-03 | Warnings | IBUPROFEN |
| Leader Childrens Ibuprofen | IBUPROFEN | Cardinal Health 110, LLC. dba Leader | 2b0c3bb1-7667-403f-99e6-13c83755b1b5 | 2025-06-03 | Warnings | IBUPROFEN |
| care one ibuprofen | IBUPROFEN | American Sales Company | 006adf23-21ab-4a4e-aae9-c4e587777165 | 2025-06-03 | Warnings | IBUPROFEN |
| up and up childrens ibuprofen | IBUPROFEN | Target Corporation | 834b7f5e-e636-4537-9bae-2d309fcc8eb3 | 2025-06-02 | Warnings | IBUPROFEN |
| equate ibuprofen childrens | IBUPROFEN | Wal-Mart Stores Inc | ed9ee7b5-2d9a-4aaf-a245-aa13fcc6365a | 2025-05-23 | Warnings | IBUPROFEN |
| ibuprofen | IBUPROFEN | Bryant Ranch Prepack | 92878aad-0bf9-4303-a1f8-4b9b23848a71 | 2025-05-21 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals, Inc. | 2c3f8149-9b77-54cd-e063-6394a90a847e | 2025-05-21 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| childrens ibuprofen | IBUPROFEN | CVS Pharmacy | 884d51d8-4774-4dde-b854-32abfb4b712d | 2025-05-20 | Warnings | IBUPROFEN |
| Ibuprofen minis | IBUPROFEN | P & L Development, LLC | 18b79fc5-57c8-46f1-81f3-2f9e189cdbcb | 2025-05-16 | Warnings | IBUPROFEN |
| dg health ibuprofen | IBUPROFEN | Dolgencorp, LLC | d6dcbdee-7c0d-4b5c-b0c1-1e8f357f7f59 | 2025-05-15 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | a60a6301-60b7-4f31-9ebe-872ccd8e9e76 | 2025-05-15 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | CHAIN DRUG MARKETING ASSOCIATION, INC. | 32f86bfb-67a6-49b5-a90a-5197f0d1baba | 2025-05-15 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | DISCOUNT DRUG MART | 9998b851-825b-a97d-e053-2a95a90affc6 | 2025-05-15 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | DISCOUNT DRUG MART | 999902da-4850-68ab-e053-2a95a90a82ea | 2025-05-15 | Warnings | IBUPROFEN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.