Application 040564
- Type
- ANDA
- Sponsor
- LNK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXYLAMINE SUCCINATE | DOXYLAMINE SUCCINATE | TABLET;ORAL | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040564-001 | DOXYLAMINE SUCCINATE | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 |
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 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | 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 |
|---|---|---|---|---|---|---|
| Night Time Sleep Aid | DOXYLAMINE SUCCINATE | Advanced Rx LLC | db8b730a-1553-4682-96bf-41e670ed0347 | 2025-02-26 | Warnings | 040564 ANDA040564 |
| Nighttime Sleep Aid | NIGHTTIME SLEEP AID | Family Dollar Stores, Inc | d91f0c21-28f0-4d32-a1d2-fae406b90bf7 | 2023-07-25 | Warnings | 040564 ANDA040564 |
| Nighttime Sleep Aid | NIGHTTIME SLEEP AID | Allegiant Health | 3761182c-275b-40f3-a262-9ef5f5a80723 | 2023-03-16 | Warnings | 040564 ANDA040564 |
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 |
|---|---|---|---|---|---|
| 11822-0386 | Sleep Aid | Doxylamine succinate | Rite Aid Corporation | ANDA | Current |
| 11822-0386 | Sleep Aid | Doxylamine succinate | Rite Aid Corporation | ANDA | Current |
| 11822-9386 | sleep aid | doxylamine succinate | Rite Aid Corporation | ANDA | Current |
| 11822-9386 | sleep aid | doxylamine succinate | Rite Aid Corporation | ANDA | Current |
| 11822-9386 | sleep aid | doxylamine succinate | Rite Aid Corporation | ANDA | Current |
| 11822-9386 | sleep aid | doxylamine succinate | Rite Aid Corporation | ANDA | Current |
| 11822-9386 | sleep aid | doxylamine succinate | Rite Aid Corporation | ANDA | Current |
| 11822-9386 | sleep aid | doxylamine succinate | Rite Aid Corporation | ANDA | Current |
| 21130-386 | Nighttime Sleep Aid | Doxylamine succinate | Better Living Brands, LLC | ANDA | Current |
| 21130-386 | Nighttime Sleep Aid | Doxylamine succinate | Better Living Brands, LLC | ANDA | Current |
| 21130-986 | Nighttime Sleep Aid | Doxylamine Succinate | Better Living Brands, LLC | ANDA | Current |
| 21130-986 | Nighttime Sleep Aid | Doxylamine Succinate | Better Living Brands, LLC | ANDA | Current |
| 21130-986 | Nighttime Sleep Aid | Doxylamine Succinate | Better Living Brands, LLC | ANDA | Current |
| 21130-986 | Nighttime Sleep Aid | Doxylamine Succinate | Better Living Brands, LLC | ANDA | Current |
| 21130-986 | Nighttime Sleep Aid | Doxylamine Succinate | Better Living Brands, LLC | ANDA | Current |
| 27854-375 | Nocto Sleep Aid | Doxylamine succinate | Belmora LLC | ANDA | Current |
| 27854-375 | Nocto Sleep Aid | Doxylamine succinate | Belmora LLC | ANDA | Current |
| 27854-375 | Nocto Sleep Aid | Doxylamine succinate | Belmora LLC | ANDA | Current |
| 27854-375 | Nocto Sleep Aid | Doxylamine succinate | Belmora LLC | ANDA | Current |
| 30142-386 | Sleep Aid | Doxylamine succinate | Kroger Company | ANDA | Current |
| 30142-386 | Sleep Aid | Doxylamine succinate | Kroger Company | ANDA | Current |
| 37205-671 | Sleep Aid | Doxylamine succinate | CARDINAL HEALTH | ANDA | Current |
| 37808-386 | Sleep-Aid | Doxylamine succinate | H E B | ANDA | Current |
| 37808-886 | Nighttime Sleep Aid | Doxylamine Succinate | H E B | ANDA | Current |
| 37808-886 | Nighttime Sleep Aid | Doxylamine Succinate | H E B | ANDA | Current |
| 37808-886 | Nighttime Sleep Aid | Doxylamine Succinate | H E B | ANDA | Current |
| 37808-886 | Nighttime Sleep Aid | Doxylamine Succinate | H E B | ANDA | Current |
| 37808-986 | Nighttime Sleep-Aid | Doxylamine succinate | H E B | ANDA | Current |
| 37808-986 | Nighttime Sleep-Aid | Doxylamine succinate | H E B | ANDA | Current |
| 37808-986 | Nighttime Sleep-Aid | Doxylamine succinate | H E B | ANDA | Current |
| 41163-386 | Sleep Aid | Doxylamine succinate | SUPERVALU INC. | ANDA | Current |
| 41163-386 | Sleep Aid | Doxylamine succinate | SUPERVALU INC. | ANDA | Current |
| 41163-986 | Sleep Aid | Doxylamine Succinate | SUPERVALU INC. | ANDA | Current |
| 41163-986 | Sleep Aid | Doxylamine Succinate | SUPERVALU INC. | ANDA | Current |
| 41163-986 | Sleep Aid | Doxylamine Succinate | SUPERVALU INC. | ANDA | Current |
| 41163-986 | Sleep Aid | Doxylamine Succinate | SUPERVALU INC. | ANDA | Current |
| 41250-986 | Sleep Aid | Doxylamine Succinate | Meijer Distribution Inc | ANDA | Current |
| 41250-986 | Sleep Aid | Doxylamine Succinate | Meijer Distribution Inc | ANDA | Current |
| 41250-986 | Sleep Aid | Doxylamine Succinate | Meijer Distribution Inc | ANDA | Current |
| 41250-986 | Sleep Aid | Doxylamine Succinate | Meijer Distribution Inc | ANDA | Current |
| 41250-986 | Sleep Aid | Doxylamine Succinate | Meijer Distribution Inc | ANDA | Current |
| 49035-863 | Nighttime Sleep Aid | Doxylamine succinate | Wal-Mart Stores Inc | ANDA | Current |
| 49035-863 | Nighttime Sleep Aid | Doxylamine succinate | Wal-Mart Stores Inc | ANDA | Current |
| 49035-968 | Sleep Aid | Doxylamine Succinate | Wal-Mart Stores Inc | ANDA | Current |
| 49035-968 | Sleep Aid | Doxylamine Succinate | Wal-Mart Stores Inc | ANDA | Current |
| 49035-968 | Sleep Aid | Doxylamine Succinate | Wal-Mart Stores Inc | ANDA | Current |
| 49035-968 | Sleep Aid | Doxylamine Succinate | Wal-Mart Stores Inc | ANDA | Current |
| 49035-968 | Sleep Aid | Doxylamine Succinate | Wal-Mart Stores Inc | ANDA | Current |
| 49035-968 | Sleep Aid | Doxylamine Succinate | Wal-Mart Stores Inc | ANDA | Current |
| 50844-260 | Nighttime Sleep Aid | Doxylamine succinate | L.N.K. International, Inc. | ANDA | Current |
| 50844-260 | Nighttime Sleep Aid | Doxylamine succinate | L.N.K. International, Inc. | ANDA | Current |
| 50844-260 | Nighttime Sleep Aid | Doxylamine succinate | L.N.K. International, Inc. | ANDA | Current |
| 50844-260 | Nighttime Sleep Aid | Doxylamine succinate | L.N.K. International, Inc. | ANDA | Current |
| 50844-260 | Nighttime Sleep Aid | Doxylamine succinate | L.N.K. International, Inc. | ANDA | Current |
| 50844-386 | Nighttime Sleep Aid | Doxylamine succinate | L.N.K. International, Inc. | ANDA | Current |
| 50844-386 | Nighttime Sleep Aid | Doxylamine succinate | L.N.K. International, Inc. | ANDA | Current |
| 50844-386 | Nighttime Sleep Aid | Doxylamine succinate | L.N.K. International, Inc. | ANDA | Current |
| 50844-386 | Nighttime Sleep Aid | Doxylamine succinate | L.N.K. International, Inc. | ANDA | Current |
| 50844-952 | Sleep Aid | Doxylamine succinate | L.N.K. International, Inc. | ANDA | Current |
| 55301-386 | Sleep Aid | Doxylamine succinate | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55301-386 | Sleep Aid | Doxylamine succinate | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55301-986 | Sleep Aid | Doxylamine Succinate | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55301-986 | Sleep Aid | Doxylamine Succinate | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55301-986 | Sleep Aid | Doxylamine Succinate | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55301-986 | Sleep Aid | Doxylamine Succinate | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55301-986 | Sleep Aid | Doxylamine Succinate | ARMY AND AIR FORCE EXCHANGE SERVICE | ANDA | Current |
| 55315-886 | Sleep Aid | Doxylamine Succinate | FRED'S, INC. | ANDA | Current |
| 55315-886 | Sleep Aid | Doxylamine Succinate | FRED'S, INC. | ANDA | Current |
| 55315-886 | Sleep Aid | Doxylamine Succinate | FRED'S, INC. | ANDA | Current |
| 55315-986 | Sleep Aid | Doxylamine succinate | FRED'S, INC. | ANDA | Current |
| 55315-986 | Sleep Aid | Doxylamine succinate | FRED'S, INC. | ANDA | Current |
| 55315-986 | Sleep Aid | Doxylamine succinate | FRED'S, INC. | ANDA | Current |
| 59779-863 | Nighttime Sleep Aid | Doxylamine succinate | CVS Pharmacy | ANDA | Current |
| 59779-863 | Nighttime Sleep Aid | Doxylamine succinate | CVS Pharmacy | ANDA | Current |
| 62011-0344 | sleep aid | doxylamine succinate | McKesson (Health Mart) | ANDA | Current |
| 62011-0401 | Sleep Aid | Doxylamine Succinate | Strategic Sourcing Services, LLC (Health Mart) | ANDA | Current |
| 62011-0401 | Sleep Aid | Doxylamine Succinate | Strategic Sourcing Services, LLC (Health Mart) | ANDA | Current |
| 62011-0401 | Sleep Aid | Doxylamine Succinate | Strategic Sourcing Services, LLC (Health Mart) | ANDA | Current |
| 62011-0401 | Sleep Aid | Doxylamine Succinate | McKesson (Health Mart) | ANDA | Current |
| 62011-0401 | Sleep Aid | Doxylamine Succinate | Strategic Sourcing Services, LLC (Health Mart) | ANDA | Current |