Home NDC 50844-260 Nighttime Sleep Aid
Product NDC 50844-260
11-digit product format 508440260
Labeler code 50844
Product ID 50844-260_e2d031e6-9d1a-4a9d-95c7-6dc6bee18a9b
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 2019-07-23
Substance DOXYLAMINE SUCCINATE
Active strength 25 mg/1
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table 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.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table 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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Nighttime Sleep Aid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYLAMINE SUCCINATE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1101446 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50844-260-21 Nighttime Sleep Aid 1 in 1 CARTON TABLET 1 9 50844-260-21 Nighttime Sleep Aid 16 in 1 BLISTER PACK TABLET 16 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50844-260 NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [L.N.K. INTERNATIONAL, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20250112_8df4ac6d-f222-4218-9dcc-3df09c91d2ae.zip
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.
Matched openFDA labels page 2 of 2 · 23 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50844-260-21 50844026021 1 BLISTER PACK in 1 CARTON (50844-260-21) / 16 TABLET in 1 BLISTER PACK 1 blister pack 2019-07-23 0000-00-00 No No Current