Application 020402
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADVIL LIQUI-GELS | IBUPROFEN | CAPSULE;ORAL | EQ 200MG FREE ACID AND POTASSIUM SALT | Yes | Yes |
| 002 | ADVIL MIGRAINE LIQUI-GELS | IBUPROFEN | CAPSULE;ORAL | EQ 200MG FREE ACID AND POTASSIUM SALT | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020402-001 | ADVIL LIQUI-GELS | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | |
| N020402-002 | ADVIL MIGRAINE LIQUI-GELS | IBUPROFEN | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020402-001 | ADVIL LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 1995-04-20 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020402-002 | ADVIL MIGRAINE LIQUI-GELS | EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE / ORAL | RLD, RS | 2000-03-16 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|
| ADVIL MIGRAINE | IBUPROFEN | Haleon US Holdings LLC | e4a6219d-4ad4-0119-4cf8-7fc39b4b5979 | 2026-07-29 | Warnings | 020402 NDA020402 0573-0168 |
| Advil | IBUPROFEN | Haleon US Holdings LLC | 1f01c10a-9434-91a4-2ee4-352315a6b610 | 2026-07-29 | Warnings | 020402 NDA020402 0573-0169 0573-1769 0573-0149 |
| Advil Liquigel | IBUPROFEN | Select Consumer Group | 3ca6bc9d-090f-e412-e063-6394a90a6876 | 2026-07-03 | Warnings | 020402 NDA020402 |
| Advil Liqui-Gels | IBUPROFEN CAPSULE, LIQUID-FILLED | Lil' Drug Store Products, Inc. | c459ea1e-dabf-bba6-e053-2995a90af40f | 2024-12-30 | Warnings | 020402 NDA020402 29485-6939 29485-2893 |
| Advil Liqui-Gels | IBUPROFEN | Lil Drug Store Products, Inc | ba5a9a04-993e-4fd6-bb40-6edfdfb69b34 | 2024-03-27 | Warnings | 020402 NDA020402 66715-9752 |
| Advil Liquigels | IBUPROFEN | Navajo Manufacturing Company Inc. | e2c09216-fd63-4d50-9878-62b36236b2e7 | 2023-03-15 | Warnings | 020402 NDA020402 67751-148 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0573-0149 | Advil | ibuprofen | Wyeth Consumer Healthcare LLC | NDA | Current |
| 0573-0149 | Advil | ibuprofen | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0573-0149 | Advil | ibuprofen | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0573-0149 | Advil | ibuprofen | Wyeth Consumer Healthcare LLC | NDA | Current |
| 0573-0149 | Advil | ibuprofen | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0573-0168 | ADVIL MIGRAINE | ibuprofen | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0573-0168 | ADVIL MIGRAINE | ibuprofen | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0573-0168 | ADVIL MIGRAINE | ibuprofen | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0573-0168 | ADVIL MIGRAINE | ibuprofen | Wyeth Consumer Healthcare LLC | NDA | Current |
| 0573-0168 | ADVIL MIGRAINE | ibuprofen | Pfizer Consumer Healthcare | NDA | Current |
| 0573-0169 | Advil | ibuprofen | Wyeth Consumer Healthcare LLC | NDA | Current |
| 0573-0169 | Advil | ibuprofen | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0573-0169 | Advil | ibuprofen | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0573-0169 | Advil | ibuprofen | Wyeth Consumer Healthcare LLC | NDA | Current |
| 0573-0169 | Advil | ibuprofen | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0573-1769 | Advil | ibuprofen | Wyeth Consumer Healthcare LLC | NDA | Current |
| 0573-1769 | Advil | ibuprofen | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0573-1769 | Advil | ibuprofen | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0573-1769 | Advil | ibuprofen | Wyeth Consumer Healthcare LLC | NDA | Current |
| 0573-1769 | Advil | ibuprofen | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 29485-2893 | Advill Liqui-Gels | IBUPROFEN Capsule, Liquid-filled | Mechanical Servants LLC | NDA | Current |
| 29485-2893 | Advill Liqui-Gels | IBUPROFEN Capsule, Liquid-filled | Mechanical Servants LLC | NDA | Current |
| 29485-2893 | Advil Liqui-Gels | IBUPROFEN Capsule, Liquid-filled | Mechanical Servants LLC | NDA | Current |
| 29485-2893 | Advil Liqui-Gels | IBUPROFEN Capsule, Liquid-filled | Mechanical Servants LLC | NDA | Current |
| 29485-2893 | Advil Liqui-Gels | IBUPROFEN Capsule, Liquid-filled | Mechanical Servants LLC | NDA | Current |
| 29485-2893 | Advil Liqui-Gels | IBUPROFEN Capsule, Liquid-filled | Mechanical Servants LLC | NDA | Current |
| 29485-6939 | Advill Liqui-Gels | IBUPROFEN Capsule, Liquid-filled | Mechanical Servants LLC | NDA | Current |
| 29485-6939 | Advil Liqui-Gels | IBUPROFEN Capsule, Liquid-filled | Mechanical Servants LLC | NDA | Current |
| 29485-6939 | Advil Liqui-Gels | IBUPROFEN Capsule, Liquid-filled | Mechanical Servants LLC | NDA | Current |
| 29485-6939 | Advil Liqui-Gels | IBUPROFEN Capsule, Liquid-filled | Mechanical Servants LLC | NDA | Current |
| 29485-6939 | Advil Liqui-Gels | IBUPROFEN Capsule, Liquid-filled | Mechanical Servants LLC | NDA | Current |
| 52904-793 | Advil Liqui-Gels | Ibuprofen | Select Corporation | NDA | Current |
| 66715-9752 | Advil Liqui-Gels | Ibuprofen | Lil Drug Store Products, Inc | NDA | Current |
| 66715-9752 | Advil Liqui-Gels | Ibuprofen | Lil Drug Store Products, Inc | NDA | Current |
| 66715-9752 | Advil Liqui-Gels | Ibuprofen | Lil Drug Store Products, Inc | NDA | Current |
| 66715-9752 | Advil Liqui-Gels | Ibuprofen | Lil Drug Store Products, Inc | NDA | Current |
| 67751-148 | Advil Liquigels | IBUPROFEN | Navajo Manufacturing Company Inc. | NDA | Current |
| 67751-148 | Advil Liquigels | IBUPROFEN | Navajo Manufacturing Company Inc. | NDA | Current |
| 67751-148 | Advil Liquigels | IBUPROFEN | Navajo Manufacturing Company Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83421 | SUPPL | 2025-09-23 |
| 80827 | SUPPL | 2025-01-10 |
| 73607 | SUPPL | 2023-02-24 |
| 73603 | SUPPL | 2023-02-24 |
| 70068 | SUPPL | 2022-02-03 |
| 55479 | SUPPL | 2018-09-14 |
| 55474 | SUPPL | 2018-09-13 |
| 55115 | SUPPL | 2018-08-03 |
| 55097 | SUPPL | 2018-08-03 |
| 50107 | SUPPL | 2017-10-19 |
| 49422 | SUPPL | 2017-08-15 |
| 49360 | SUPPL | 2017-08-15 |
| 49166 | SUPPL | 2017-08-01 |
| 49165 | SUPPL | 2017-08-01 |
| 34603 | SUPPL | 2015-12-22 |
| 2482 | SUPPL | 2015-12-18 |
| 34602 | SUPPL | 2015-07-09 |
| 2481 | SUPPL | 2011-04-22 |
| 24909 | SUPPL | 2009-07-15 |
| 24908 | SUPPL | 2009-05-26 |
| 2480 | SUPPL | 2008-06-17 |
| 2478 | SUPPL | 2006-05-02 |
| 2479 | SUPPL | 2006-02-22 |
| 2477 | SUPPL | 2004-02-27 |
| 20633 | SUPPL | 2003-07-08 |
| 24907 | SUPPL | 2000-03-16 |
| 12536 | SUPPL | 2000-03-16 |