Home NDC 42507-033 nighttime sleep aid
Product NDC 42507-033
11-digit product format 425070033
Labeler code 42507
Product ID 42507-033_cb5d207d-c077-48df-92d2-a27ef29b73bd
Type HUMAN OTC DRUG
Nonproprietary name Doxylamine succinate
Dosage form TABLET
Route ORAL
Labeler HyVee Inc
Application ANDA040167
Marketing category ANDA
Marketing start 2014-12-04
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42507-033-73 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42507-033-73 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42507-033-73 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42507-033-73 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42507-033-73 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42507-033-73 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42507-033-73 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42507-033-73 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42507-033-73 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42507-033-73 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42507-033-73 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42507-033-73 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A040167-001 DOXYLAMINE SUCCINATE DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18
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.
Product history page 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040167-001 DOXYLAMINE SUCCINATE 25MG TABLET / ORAL 1996-09-18 cb3db0bc1861…
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 42507-033-64 nighttime sleep aid 1 in 1 BLISTER PACK TABLET 1 4 42507-033-64 nighttime sleep aid 32 in 1 CARTON TABLET 32 4 42507-033-73 nighttime sleep aid 16 in 1 CARTON TABLET 16 4 42507-033-73 nighttime sleep aid 1 in 1 BLISTER PACK TABLET 1 4
DailyMed Socrata Ingredients# 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 1 of 2 · 22 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42507-033-64 42507003364 32 BLISTER PACK in 1 CARTON (42507-033-64) / 1 TABLET in 1 BLISTER PACK 32 blister pack 2026-02-25 No No Current 42507-033-73 42507003373 16 in 1 CARTON Historical