Application 020602
- Type
- NDA
- Sponsor
- J AND J CONSUMER INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | JUNIOR STRENGTH MOTRIN | IBUPROFEN | TABLET;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020602-001 | JUNIOR STRENGTH MOTRIN | IBUPROFEN | 100MG | TABLET / ORAL | 1996-06-10 |
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 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N020602-001 | JUNIOR STRENGTH MOTRIN | 100MG | TABLET / ORAL | 1996-06-10 | f41ea6bd6efb… |
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 | TARGET CORPORATION | 8e872c8d-28e2-cd49-e053-2995a90a469f | 2024-01-03 | Warnings | IBUPROFEN |
| IBUPROFEN 200 MG | IBUPROFEN | Basic Drugs, Inc. | d3351d44-2078-3adc-e053-2995a90a3c8f | 2024-01-03 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Amneal Pharmaceuticals of New York LLC | 59f14d2b-f48a-4c25-bea3-3dc9100898b2 | 2023-12-31 | Warnings | IBUPROFEN |
| Ibuprofen Pain Releiver/ Fever Reducer | IBUPROFEN | Amneal Pharmaceuticals of New York LLC | ee241be0-35f8-4789-a71f-98de31d6a590 | 2023-12-31 | Warnings | IBUPROFEN |
| Ibuprofen (NSAID) Pain Releiver/ Fever Reducer | IBUPROFEN | Amneal Pharmaceuticals of New York LLC | a8c6bc4e-1e48-4613-8cbf-8c5cd9d51ad0 | 2023-12-31 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Amneal Pharmaceuticals NY LLC | e07d989d-1b0e-4cc1-abf2-93c8b208a29a | 2023-12-30 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Childrens Ibuprofen Oral Suspension | IBUPROFEN | DEMOULAS SUPERMARKETS INC. | 4ca54293-9e81-4b24-8112-734f28cd2c55 | 2023-12-29 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Bionpharma Inc. | 4bc6e8f2-ba95-4352-80ed-b44608fc4936 | 2023-12-27 | Warnings | IBUPROFEN |
| Dye-Free Ibuprofen | IBUPROFEN | RITE AID CORPORATION | c1c58a2d-9ffd-69d0-e053-2a95a90a5718 | 2023-12-27 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | f1f1e0ac-6944-4123-9e08-1df91582d457 | 2023-12-13 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 8553e29a-7f6f-4ff8-9991-836e619c504d | 2023-12-10 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Childrens Ibuprofen | IBUPROFEN | American Health Packaging | bc69d88b-d9af-4010-8e8f-e761a9e295a9 | 2023-12-05 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 7152b6ce-6113-4003-bf80-aa263be69392 | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Ibuprofen | IBUPROFEN | A-S Medication Solutions | 400faee1-f662-470e-bcd6-7711dfaf9ba2 | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| Childrens Ibuprofen | IBUPROFEN | Chain Drug Marketing Association Inc. | e210c707-2bae-44a5-93dc-459dd24fd960 | 2023-11-20 | Warnings | IBUPROFEN |
| Childrens Ibuprofen | IBUPROFEN | Chain Drug Marketing Association Inc. | c7e59784-a338-4922-a806-98c7505957cd | 2023-11-10 | Warnings | IBUPROFEN |
| Concentrated ibuprofen infants | IBUPROFEN | Chain Drug Marketing Association Inc. | c9ae72d8-d205-4736-9bc4-2325cd77d36b | 2023-11-03 | Warnings | IBUPROFEN |
| foster and thrive ibuprofen | IBUPROFEN | Strategic Sourcing Services LLC | 68d67a25-e669-47c7-8410-9f304b914ff1 | 2023-10-31 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Geri-Care Pharmaceutical Corp | 0744c3ca-4224-4f6a-a033-880949b544fd | 2023-10-30 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | TIME CAP LABORATORIES, INC. | 059cb22f-f6db-5d03-e063-6294a90a9ec1 | 2023-10-27 | Warnings | IBUPROFEN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.