FDA.reportPublic FDA data

Nighttime Sleep Aid

Product NDC
85828-439
11-digit product format
858280439
Labeler code
85828
Product ID
85828-439_9c3f7355-11a8-4274-bcab-8674264b57d1
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine Succinate
Dosage form
TABLET
Route
ORAL
Labeler
Grocery Outlet
Application
ANDA040564
Marketing category
ANDA
Marketing start
2026-03-18
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 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
A040564-001DOXYLAMINE SUCCINATEDOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040564-001DOXYLAMINE SUCCINATE25MGTABLET / ORAL2004-08-27a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Sleep AidDOXYLAMINE SUCCINATEH E B17667c28-b61e-4974-8736-5de59f69b3b02026-07-09WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Sleep-AidDOXYLAMINE SUCCINATECardinal Health 110, LLC. DBA Leader96e8d6df-e717-4ffc-9502-498024c9665f2026-07-09WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Nocto Sleep AidDOXYLAMINE SUCCINATEBelmora LLCd255309b-0023-48fe-890f-6a4fe04dbb852026-07-09WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Nighttime Sleep AidDOXYLAMINE SUCCINATEAmerisource Bergenea842bc4-9788-49a9-a7e1-d6e3dd61056a2026-06-15WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Sleep AidDOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED6d6e47df-a965-4813-8414-9841ed2f9e0c2026-06-15WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Sleep AidDOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE009df4c9-a524-4b8f-be7a-52c521e68ff12026-05-18WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Sleep AidDOXYLAMINE SUCCINATEStrategic Sourcing Services LLCeddec8bc-2bed-4bc5-a1c2-39424a6998382026-05-13WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Sleep AidDOXYLAMINE SUCCINATEWal-Mart Stores Inc71e0cef1-6195-4b67-9c1f-b4e5fbeae53c2026-05-13WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Sleep AidDOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI005b5ad8-d762-46b5-a7a5-e0ff11ba936a2026-04-06WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Nighttime Sleep AidDOXYLAMINE SUCCINATEBetter Living Brands, LLC92827089-88d5-4f4e-bcbe-3ca6d94ee96c2026-03-27WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Sleep AidDOXYLAMINE SUCCINATEMeijer Distribution Inc96a7c284-4666-4dac-b71e-9433f62580ad2026-03-27WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Nighttime Sleep AidDOXYLAMINE SUCCINATEL.N.K. International, Inc.918ad808-ccfd-429f-9052-19905a6346062026-03-27WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Unisom SleepTabsDOXYLAMINE SUCCINATEChattem, Inc.7ae32d74-76a0-47e2-9e5c-812426413c4e2026-03-25WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Nighttime Sleep AidDOXYLAMINE SUCCINATEGrocery Outletbc13c6c1-1706-4f8c-9789-448f7fe4628d2026-03-18WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
ndc (product): 85828-439
Sleep AidDOXYLAMINE SUCCINATEWalgreen Companyd812217b-b2f2-4716-92f4-c16bd0768e172026-02-11WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Nighttime Sleep AidDOXYLAMINE SUCCINATEL.N.K. International, Inc.8df4ac6d-f222-4218-9dcc-3df09c91d2ae2026-01-06WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
SLEEP AID 25mgDOXYLAMINE SUCCINATEYYBA CORPa436f6d2-6d7e-4f0e-b1c3-acc17cbcb64a2025-12-02WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Nighttime Sleep-AidDOXYLAMINE SUCCINATEKroger Company8b85812e-33a3-4534-bfba-ee4502d11d342025-09-23WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Sleep AidDOXYLAMINE SUCCINATEKroger Company76e1e49d-eb57-4590-8cf8-91f29dbd15c32025-08-22WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564
Nighttime Sleep AidDOXYLAMINE SUCCINATECVS PHARMACY0b08ca81-1d07-4a57-9cbd-72e3a6a378142025-08-19WarningsExact identifier
application applno (ANDA): 040564
application number: ANDA040564

Additional Listing Data#

Finished product
Yes
Brand name base
Nighttime Sleep Aid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYLAMINE SUCCINATE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1101446Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc13c6c1-1706-4f8c-9789-448f7fe4628dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85828-439-38Nighttime Sleep Aid2 in 1 CARTONTABLET21
85828-439-38Nighttime Sleep Aid16 in 1 BLISTER PACKTABLET161

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSNbc13c6c1-1706-4f8c-9789-448f7fe4628d1
1101446doxylamine succinate 25 MG Oral TabletSCDbc13c6c1-1706-4f8c-9789-448f7fe4628d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85828-439-38858280439382 BLISTER PACK in 1 CARTON (85828-439-38) / 16 TABLET in 1 BLISTER PACK2 blister pack2026-03-18NoNoCurrent