FDA.reportPublic FDA data

sound body nighttime sleep aid

Product NDC
50594-441
11-digit product format
505940441
Labeler code
50594
Product ID
50594-441_e5616c38-2fc0-4e20-8ae2-a5487b9ecf31
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
Big Lots Stores, Inc.
Application
ANDA040167
Marketing category
ANDA
Marketing start
2019-04-24
Marketing end
0000-00-00
Substance
DOXYLAMINE SUCCINATE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50594-441DDiscontinued by firm2026-08-07
excluded packagepackage50594-44150594-441-64DDiscontinued by firm2026-08-07

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040167-001DOXYLAMINE SUCCINATEDOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-183f01610625f2…
2019-09-15 20:21 UTC2019-09A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040167-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL1996-09-18cb3db0bc1861…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50594-441SOUND BODY NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [BIG LOTS STORES, INC.]2Legacy NDC20200806_da26764a-fa08-4b92-a7a5-fb20907f4555.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 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sleep aidDOXYLAMINE SUCCINATERite Aid Corporation4b5fdb06-f205-4424-b4cb-dddef921485b2026-05-27WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
sleep aidDOXYLAMINE SUCCINATEWalgreen Company489ee606-15f4-4032-a62b-35c8844f1a262026-05-08WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
nighttime sleep aidDOXYLAMINE SUCCINATEHyVee Inc95b12a14-21ee-431d-a892-46f8cdca2d7a2026-04-15WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
Sleep AidDOXYLAMINE SUCCINATEMeijer Distribution Incde0a6f68-6988-44df-9fab-b87620fd32e82026-03-24WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
NIGHTTIME SLEEP AIDDOXYLAMINE SUCCINATECVS Pharmacy05050b61-2417-48f0-9478-c39d6a3410262026-02-27WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
Unisom SleepTabsDOXYLAMINE SUCCINATEChattem, Inc.f591d52f-5610-4517-a96f-1ed63deb00bc2026-01-14WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
Good sense sleep aidDOXYLAMINE SUCCINATEL. Perrigo Companyf0a0eb93-96e0-432b-9b82-f0e891483be02025-11-14WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
Vicks ZzzQuil UltraDOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyc29f6f9a-7b55-30c3-e053-2995a90a9de72025-10-02WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
Basic Care Sleep AidDOXYLAMINE SUCCINATEAmazon.com Services LLCe09cd229-638b-4065-8325-ed2c1ce2e99d2025-08-19WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
sleep aid ultraDOXYLAMINE SUCCINATEMeijer, Inc.792632af-01c1-4a9b-99f4-8eb84d0fc3892025-06-16WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
sleep aidDOXYLAMINE SUCCINATEPublix Super Markets Inc377ebf03-c1d5-4362-98b3-032206df9e8e2025-05-23WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
good sense sleep aid ultraDOXYLAMINE SUCCINATEL. Perrigo Company300826cf-6d0d-4efb-97aa-aa7dfff3add22025-04-02WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
up and up nighttime sleep aidDOXYLAMINE SUCCINATETarget Corporation24a0144d-cbfc-4d2f-873d-86adfa0468ca2025-04-02WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
CareOne Nighttime Sleep AidDOXYLAMINE SUCCINATEAmerican Sales Companyf8bfc874-53be-41e8-b59c-d538825761a82025-04-01WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
berkley and jensen sleep aidDOXYLAMINE SUCCINATEBJWC25f468a9-71d4-40f2-97bb-1c3ff5d4b7282025-03-31WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
topcare sleep aidDOXYLAMINE SUCCINATETopco Associates LLCc8b24ed8-34a1-4857-8fcb-6e3f9d4079032025-03-26WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
good sense sleep aid ultraDOXYLAMINE SUCCINATEL. Perrigo Company6907ffd1-39cb-4cc5-9c8a-bd975a5b06bd2025-03-06WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
dg health sleep aidDOXYLAMINE SUCCINATEDolgencorp Inca4c6b400-7fa6-4ad1-9d39-d34621eb91a62025-03-05WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
TopCare Sleep AidDOXYLAMINE SUCCINATETopco Associates LLC15dc89c4-b7ce-4d36-8107-f501daaf289b2025-02-16WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167
ultra sleep aidDOXYLAMINE SUCCINATEWalgreen Company90a5986d-2555-4c2d-8e41-16537ff1aa362025-02-07WarningsExact identifier
application applno (ANDA): 040167
application number: ANDA040167

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50594-441-645059404416432 BLISTER PACK in 1 CARTON (50594-441-64) > 1 TABLET in 1 BLISTER PACK32 blister pack2019-04-240000-00-00NoNoCurrent