FDA.reportPublic FDA data

Application 018066

Type
NDA
Sponsor
CHATTEM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UNISOMDOXYLAMINE SUCCINATETABLET;ORAL25MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N018066-001UNISOMDOXYLAMINE SUCCINATE25MGTABLET / ORALRLD, RS, Approved before 1982

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N018066-001UNISOM25MGTABLET / ORALRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018066-001UNISOM25MGTABLET / ORALRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018066-001UNISOM25MGTABLET / ORALRLD, RS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018066-001UNISOM25MGTABLET / ORALRLD, RS, Approved before 1982a50c72e98297…

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 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SLEEP AIDDOXYLAMINE SUCCINATEAmazon.com Services LLCc4509e0a-cb9d-454c-a67b-812a0ba62be12026-09-02WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATECOSTCO WHOLESALE CORPORATION74a728e1-9ca1-4219-9427-b503ab0480b42026-08-28WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
ultra sleep aidDOXYLAMINE SUCCINATEWalgreen Company90a5986d-2555-4c2d-8e41-16537ff1aa362026-08-19WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep AidDOXYLAMINE SUCCINATEH E B17667c28-b61e-4974-8736-5de59f69b3b02026-07-09WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep-AidDOXYLAMINE SUCCINATECardinal Health 110, LLC. DBA Leader96e8d6df-e717-4ffc-9502-498024c9665f2026-07-09WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nocto Sleep AidDOXYLAMINE SUCCINATEBelmora LLCd255309b-0023-48fe-890f-6a4fe04dbb852026-07-09WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep AidDOXYLAMINE SUCCINATEAmerisource Bergenea842bc4-9788-49a9-a7e1-d6e3dd61056a2026-06-15WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED6d6e47df-a965-4813-8414-9841ed2f9e0c2026-06-15WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
sleep aidDOXYLAMINE SUCCINATERite Aid Corporation4b5fdb06-f205-4424-b4cb-dddef921485b2026-05-27WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE009df4c9-a524-4b8f-be7a-52c521e68ff12026-05-18WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATEStrategic Sourcing Services LLCeddec8bc-2bed-4bc5-a1c2-39424a6998382026-05-13WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATEWal-Mart Stores Inc71e0cef1-6195-4b67-9c1f-b4e5fbeae53c2026-05-13WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
sleep aidDOXYLAMINE SUCCINATEWalgreen Company489ee606-15f4-4032-a62b-35c8844f1a262026-05-08WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
nighttime sleep aidDOXYLAMINE SUCCINATEHyVee Inc95b12a14-21ee-431d-a892-46f8cdca2d7a2026-04-15WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI005b5ad8-d762-46b5-a7a5-e0ff11ba936a2026-04-06WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep AidDOXYLAMINE SUCCINATEBetter Living Brands, LLC92827089-88d5-4f4e-bcbe-3ca6d94ee96c2026-03-27WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATEMeijer Distribution Inc96a7c284-4666-4dac-b71e-9433f62580ad2026-03-27WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Nighttime Sleep AidDOXYLAMINE SUCCINATEL.N.K. International, Inc.918ad808-ccfd-429f-9052-19905a6346062026-03-27WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Unisom SleepTabsDOXYLAMINE SUCCINATEChattem, Inc.7ae32d74-76a0-47e2-9e5c-812426413c4e2026-03-25WarningsName fallback
generic name: DOXYLAMINE SUCCINATE
Sleep AidDOXYLAMINE SUCCINATEMeijer Distribution Incde0a6f68-6988-44df-9fab-b87620fd32e82026-03-24WarningsName fallback
generic name: DOXYLAMINE SUCCINATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
41167-0060Unisom SleepTabsDoxylamine SuccinateChattem, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72774SUPPL2022-12-05
72764SUPPL2022-12-02
33410SUPPL2013-09-24
14009SUPPL2013-09-13
14008SUPPL2002-05-30
14007SUPPL2002-05-30