Home Applications 040167 Application 040167
Type ANDA
Sponsor PERRIGO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOXYLAMINE SUCCINATE DOXYLAMINE SUCCINATE TABLET;ORAL 25MG No No
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…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 48 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0441 Good sense sleep aid Doxylamine succinate L. Perrigo Company ANDA Current 0113-0441 Good sense sleep aid Doxylamine succinate L. Perrigo Company ANDA Current 0113-6044 good sense sleep aid ultra Doxylamine Succinate L. Perrigo Company ANDA Current 0113-7441 basic care sleep aid Doxylamine succinate L. Perrigo Company ANDA Current 0113-7441 basic care sleep aid Doxylamine succinate L. Perrigo Company ANDA Current 0363-0441 WAL SOM Doxylamine succinate Walgreen Company ANDA Current 0363-0441 WAL SOM Doxylamine succinate Walgreen Company ANDA Current 0363-1301 sleep aid Doxylamine succinate Walgreen Company ANDA Current 10202-441 7 Select Sleep Aid Doxylamine succinate 7-Eleven ANDA Current 10202-441 7 Select Sleep Aid Doxylamine succinate 7-Eleven ANDA Current 11673-171 up and up nighttime sleep aid Doxylamine succinate Target Corporation ANDA Current 24385-441 Good Neighbor Pharmacy Sleep Aid Doxylamine succinate Amerisource Bergen ANDA Current 24385-441 Good Neighbor Pharmacy Sleep Aid Doxylamine succinate Amerisource Bergen ANDA Current 30142-158 nighttime sleep aid Doxylamine succinate Kroger Company ANDA Current 30142-158 nighttime sleep aid Doxylamine succinate Kroger Company ANDA Current 30142-158 nighttime sleep aid Doxylamine succinate Kroger Company ANDA Current 36800-441 TopCare Sleep Aid Doxylamine succinate Topco Associates LLC ANDA Current 36800-441 TopCare Sleep Aid Doxylamine succinate Topco Associates LLC ANDA Current 41167-0063 Unisom SleepTabs Doxylamine Succinate Chattem, Inc. ANDA Current 41167-0063 Unisom SleepTabs Doxylamine Succinate Chattem, Inc. ANDA Current 41190-441 ShopRite Sleep-Aid Doxylamine succinate Wakefern Food Corporation ANDA Current 41520-634 CareOne Nighttime Sleep Aid Doxylamine succinate American Sales Company ANDA Current 41520-634 CareOne Nighttime Sleep Aid Doxylamine succinate American Sales Company ANDA Current 49348-574 Sunmark sleep aid Doxylamine succinate Strategic Sourcing Services LLC ANDA Current 49348-574 Sunmark sleep aid Doxylamine succinate McKesson ANDA Current 49738-441 smart sense sleep aid Doxylamine succinate Kmart Corporation ANDA Current 50594-441 sound body nighttime sleep aid Doxylamine succinate Big Lots Stores, Inc. ANDA Current 50594-441 sound body nighttime sleep aid Doxylamine succinate Big Lots Stores, Inc. ANDA Current 55316-441 healthy accents sleep aid Doxylamine succinate DZA Brands LLC ANDA Current 59779-441 NIGHTTIME SLEEP AID Doxylamine succinate CVS Pharmacy ANDA Current 59779-441 NIGHTTIME SLEEP AID Doxylamine succinate CVS Pharmacy ANDA Current 59779-441 NIGHTTIME SLEEP AID Doxylamine succinate CVS Pharmacy ANDA Current 59779-441 NIGHTTIME SLEEP AID Doxylamine succinate CVS Pharmacy ANDA Current 59779-441 NIGHTTIME SLEEP AID Doxylamine succinate CVS Pharmacy ANDA Current 59779-441 NIGHTTIME SLEEP AID Doxylamine succinate CVS Pharmacy ANDA Current 62011-0037 Health Mart Sleep Aid Doxylamine succinate McKesson ANDA Current 68391-441 berkley and jensen sleep aid Doxylamine succinate BJWC ANDA Current 69256-441 Harris Teeter Sleep Aid Doxylamine succinate Harris Teeter, LLC ANDA Current 69256-441 Harris Teeter Sleep Aid Doxylamine succinate Harris Teeter, LLC ANDA Current 69423-902 Vicks ZzzQuil Doxylamine succinate The Procter & Gamble Manufacturing Company ANDA Current 69423-902 Vicks ZzzQuil Doxylamine succinate The Procter & Gamble Manufacturing Company ANDA Current 69423-902 Vicks ZzzQuil Doxylamine succinate The Procter & Gamble Manufacturing Company ANDA Current 70000-0005 LEADER SLEEP AID Doxylamine succinate Cardinal Health ANDA Current 70000-0005 LEADER SLEEP AID Doxylamine succinate Cardinal Health ANDA Current 70000-0005 LEADER SLEEP AID Doxylamine succinate Cardinal Health 110, LLC. dba Leader ANDA Current 72288-441 Basic Care Sleep Aid Doxylamine succinate Amazon.com Services LLC ANDA Current 72288-441 Basic Care Sleep Aid Doxylamine succinate Amazon.com Services Inc. ANDA Current 79481-0096 sleep aid ultra Doxylamine Succinate Meijer, Inc. ANDA Current