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 |
|---|---|---|---|---|---|---|
| Childrens Ibuprofen Oral Suspension | IBUPROFEN | Discount Drug Mart | 7b7954b7-e4c8-4284-a649-31a4eb6ba73e | 2025-12-19 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Walgreens | 07edb8d0-2fa8-4b40-e063-6294a90a2fe9 | 2025-12-19 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Family Dollar | fe17f5a6-fd6d-d839-e053-6394a90a59a4 | 2025-12-19 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | f24582be-8d70-4848-bd54-e55fa28f394f | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| ibuprofen | IBUPROFEN | NuCare Pharmaceuticals, Inc. | 463ea713-6b27-b00b-e063-6394a90a8646 | 2025-12-18 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | BETTER LIVING BRANDS LLC. | a3c1a61b-88fc-419c-e053-2a95a90ac0c3 | 2025-12-18 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | BETTER LIVING BRANDS LLC. | 8c3ca03e-0ec2-c15c-e053-2995a90ad8bd | 2025-12-18 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | e5db46f3-043b-40ac-a89b-c90bd562e7b4 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 3db0c659-cc43-45dc-8442-bc89093d94d7 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Major Pharmaceuticals | 6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f6 | 2025-12-17 | Warnings | IBUPROFEN |
| ibuprofen | IBUPROFEN | PD-Rx Pharmaceuticals, Inc. | 96bff700-bca3-4b94-b8a2-379102721db8 | 2025-12-15 | Warnings | IBUPROFEN |
| topcare childrens ibuprofen | IBUPROFEN | Topco Associates LLC | d1bb68a6-3a29-4a4e-b4e9-413cc8d16191 | 2025-12-12 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | VALU MERCHANDISERS COMPANY | 7e2ab4f1-2e87-4fbf-8882-e4d20aef142c | 2025-12-11 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | VALU MERCHANDISERS COMPANY | a42f96c4-322d-4714-9435-7b5a4e8b6ae5 | 2025-12-11 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | VALU MERCHANDISERS COMPANY | 02e4418a-93ed-2212-e063-6294a90a6c8a | 2025-12-11 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | VALU MERCHANDISERS COMPANY | 88b3f388-46d3-4e42-98fb-0351c76a15fc | 2025-12-11 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | VALU MERCHANDISERS COMPANY | 36b95840-f621-437a-bf49-406d320964da | 2025-12-11 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | CHAIN DRUG MARKETING ASSOCIATION INC | 9c1ded4e-1d3b-1ab6-e053-2995a90aa80d | 2025-12-10 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | CHAIN DRUG MARKETING ASSOCIATION INC | 9c1cc205-b9e3-03fc-e053-2995a90aaffb | 2025-12-10 | Warnings | IBUPROFEN |
| Motrin IB, TRAVEL BASIX | IBUPROFEN | Lil' Drug Store Products, Inc. | c2b99756-3e03-4d9f-9ce6-7db879afe3a1 | 2025-12-10 | Warnings | IBUPROFEN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.