Sleep Aid
- Product NDC
- 50844-952
- 11-digit product format
- 508440952
- Labeler code
- 50844
- Product ID
- 50844-952_09cc14a2-9eed-4d42-92a1-f0adfb912107
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Doxylamine succinate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- L.N.K. International, Inc.
- Application
- ANDA040564
- Marketing category
- ANDA
- Marketing start
- 2002-04-11
- Marketing end
- 0000-00-00
- Substance
- DOXYLAMINE SUCCINATE
- Active strength
- 25 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040564-001 | DOXYLAMINE SUCCINATE | 25MG | TABLET / ORAL | 2004-08-27 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Nighttime Sleep Aid | DOXYLAMINE SUCCINATE | H E B | 17667c28-b61e-4974-8736-5de59f69b3b0 | 2026-07-09 | Warnings | 040564 ANDA040564 |
| Sleep-Aid | DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. DBA Leader | 96e8d6df-e717-4ffc-9502-498024c9665f | 2026-07-09 | Warnings | 040564 ANDA040564 |
| Nocto Sleep Aid | DOXYLAMINE SUCCINATE | Belmora LLC | d255309b-0023-48fe-890f-6a4fe04dbb85 | 2026-07-09 | Warnings | 040564 ANDA040564 |
| Nighttime Sleep Aid | DOXYLAMINE SUCCINATE | Amerisource Bergen | ea842bc4-9788-49a9-a7e1-d6e3dd61056a | 2026-06-15 | Warnings | 040564 ANDA040564 |
| Sleep Aid | DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 6d6e47df-a965-4813-8414-9841ed2f9e0c | 2026-06-15 | Warnings | 040564 ANDA040564 |
| Sleep Aid | DOXYLAMINE SUCCINATE | ARMY AND AIR FORCE EXCHANGE SERVICE | 009df4c9-a524-4b8f-be7a-52c521e68ff1 | 2026-05-18 | Warnings | 040564 ANDA040564 |
| Sleep Aid | DOXYLAMINE SUCCINATE | Strategic Sourcing Services LLC | eddec8bc-2bed-4bc5-a1c2-39424a699838 | 2026-05-13 | Warnings | 040564 ANDA040564 |
| Sleep Aid | DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 71e0cef1-6195-4b67-9c1f-b4e5fbeae53c | 2026-05-13 | Warnings | 040564 ANDA040564 |
| Sleep Aid | DOXYLAMINE SUCCINATE | United Natural Foods, Inc. dba UNFI | 005b5ad8-d762-46b5-a7a5-e0ff11ba936a | 2026-04-06 | Warnings | 040564 ANDA040564 |
| Nighttime Sleep Aid | DOXYLAMINE SUCCINATE | Better Living Brands, LLC | 92827089-88d5-4f4e-bcbe-3ca6d94ee96c | 2026-03-27 | Warnings | 040564 ANDA040564 |
| Sleep Aid | DOXYLAMINE SUCCINATE | Meijer Distribution Inc | 96a7c284-4666-4dac-b71e-9433f62580ad | 2026-03-27 | Warnings | 040564 ANDA040564 |
| Nighttime Sleep Aid | DOXYLAMINE SUCCINATE | L.N.K. International, Inc. | 918ad808-ccfd-429f-9052-19905a634606 | 2026-03-27 | Warnings | 040564 ANDA040564 |
| Unisom SleepTabs | DOXYLAMINE SUCCINATE | Chattem, Inc. | 7ae32d74-76a0-47e2-9e5c-812426413c4e | 2026-03-25 | Warnings | 040564 ANDA040564 |
| Nighttime Sleep Aid | DOXYLAMINE SUCCINATE | Grocery Outlet | bc13c6c1-1706-4f8c-9789-448f7fe4628d | 2026-03-18 | Warnings | 040564 ANDA040564 |
| Sleep Aid | DOXYLAMINE SUCCINATE | Walgreen Company | d812217b-b2f2-4716-92f4-c16bd0768e17 | 2026-02-11 | Warnings | 040564 ANDA040564 |
| Nighttime Sleep Aid | DOXYLAMINE SUCCINATE | L.N.K. International, Inc. | 8df4ac6d-f222-4218-9dcc-3df09c91d2ae | 2026-01-06 | Warnings | 040564 ANDA040564 |
| SLEEP AID 25mg | DOXYLAMINE SUCCINATE | YYBA CORP | a436f6d2-6d7e-4f0e-b1c3-acc17cbcb64a | 2025-12-02 | Warnings | 040564 ANDA040564 |
| Nighttime Sleep-Aid | DOXYLAMINE SUCCINATE | Kroger Company | 8b85812e-33a3-4534-bfba-ee4502d11d34 | 2025-09-23 | Warnings | 040564 ANDA040564 |
| Sleep Aid | DOXYLAMINE SUCCINATE | Kroger Company | 76e1e49d-eb57-4590-8cf8-91f29dbd15c3 | 2025-08-22 | Warnings | 040564 ANDA040564 |
| Nighttime Sleep Aid | DOXYLAMINE SUCCINATE | CVS PHARMACY | 0b08ca81-1d07-4a57-9cbd-72e3a6a37814 | 2025-08-19 | Warnings | 040564 ANDA040564 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50844-952-00 | 50844095200 | 2 BOTTLE, PLASTIC in 1 PACKAGE (50844-952-00) > 96 TABLET in 1 BOTTLE, PLASTIC | 2002-04-11 | 0000-00-00 | No | No | Current | |
| 50844-952-08 | 50844095208 | 1 BOTTLE, PLASTIC in 1 CARTON (50844-952-08) > 24 TABLET in 1 BOTTLE, PLASTIC | 2002-04-11 | 0000-00-00 | No | No | Current | |
| 50844-952-19 | 50844095219 | 1 BLISTER PACK in 1 CARTON (50844-952-19) > 8 TABLET in 1 BLISTER PACK | 1 blister pack | 2002-04-11 | 0000-00-00 | No | No | Current |
| 50844-952-21 | 50844095221 | 1 BLISTER PACK in 1 CARTON (50844-952-21) > 16 TABLET in 1 BLISTER PACK | 1 blister pack | 2002-04-11 | 0000-00-00 | No | No | Current |
| 50844-952-22 | 50844095222 | 3 BLISTER PACK in 1 CARTON (50844-952-22) > 16 TABLET in 1 BLISTER PACK | 3 blister pack | 2002-04-11 | 0000-00-00 | No | No | Current |
| 50844-952-26 | 50844095226 | 1000 BLISTER PACK in 1 BOX (50844-952-26) > 16 TABLET in 1 BLISTER PACK | 1000 blister pack | 2002-04-11 | 0000-00-00 | No | No | Current |
| 50844-952-27 | 50844095227 | 2 BLISTER PACK in 1 CARTON (50844-952-27) > 16 TABLET in 1 BLISTER PACK | 2 blister pack | 2002-04-11 | 0000-00-00 | No | No | Current |
| 50844-952-46 | 50844095246 | 1 BOTTLE in 1 CARTON (50844-952-46) > 96 TABLET in 1 BOTTLE | 1 bottle | 2002-04-11 | 0000-00-00 | No | No | Current |
| 50844-952-90 | 50844095290 | 32 TABLET in 1 BOTTLE, PLASTIC (50844-952-90) | 32 tablet | 2002-04-11 | 0000-00-00 | No | No | Current |
| 50844-952-96 | 50844095296 | 2 BOTTLE, PLASTIC in 1 CARTON (50844-952-96) > 96 TABLET in 1 BOTTLE, PLASTIC | 2002-04-11 | 0000-00-00 | No | No | Current |