Application 020944
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHILDREN'S ADVIL | IBUPROFEN | TABLET, CHEWABLE;ORAL | 50MG | No | No |
| 002 | JUNIOR STRENGTH ADVIL | IBUPROFEN | TABLET, CHEWABLE;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020944-001 | CHILDREN'S ADVIL | IBUPROFEN | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | ||
| N020944-002 | JUNIOR STRENGTH ADVIL | IBUPROFEN | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020944-001 | CHILDREN'S ADVIL | 50MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020944-002 | JUNIOR STRENGTH ADVIL | 100MG | TABLET, CHEWABLE / ORAL | 1998-12-18 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| JUNIOR STRENGTH ADVIL | IBUPROFEN | Haleon US Holdings LLC | 07d4c400-b182-92f7-7574-9e0e94c39cce | 2025-06-27 | Warnings | 020944 NDA020944 0573-0179 |
| JUNIOR STRENGTH ADVIL | IBUPROFEN | Proficient Rx LP | 91fc4794-1880-460f-86dd-49d8c1e872bc | 2020-03-01 | Warnings | 020944 NDA020944 71205-425 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0573-0179 | JUNIOR STRENGTH ADVIL | ibuprofen | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | NDA | Current |
| 0573-0179 | JUNIOR STRENGTH ADVIL | ibuprofen | Wyeth Consumer Healthcare LLC | NDA | Current |
| 71205-425 | JUNIOR STRENGTH ADVIL | ibuprofen | Proficient Rx LP | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85821 | SUPPL | 2026-05-04 |
| 47766 | SUPPL | 2017-03-29 |
| 47743 | SUPPL | 2017-03-28 |
| 41827 | SUPPL | 2013-04-18 |
| 21296 | SUPPL | 2013-04-18 |
| 3821 | SUPPL | 2009-05-27 |
| 3820 | SUPPL | 2008-06-13 |
| 26266 | SUPPL | 2006-04-07 |
| 26265 | SUPPL | 2004-12-30 |
| 3819 | SUPPL | 2004-12-30 |
| 21295 | ORIG | 2004-05-26 |
| 35691 | ORIG | 1998-12-18 |
| 3818 | ORIG | 1998-12-18 |