FDA.reportPublic FDA data

Sleep Aid

Product NDC
63981-986
11-digit product format
639810986
Labeler code
63981
Product ID
63981-986_9868afb4-8361-418f-ac27-b1ac7d3b3198
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
COSTCO WHOLESALE CORPORATION
Application
ANDA040564
Marketing category
ANDA
Marketing start
2019-05-03
Substance
DOXYLAMINE SUCCINATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYLAMINE SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV9BI9B5YI2
Rxcui1101446

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
63981-986-44Sleep Aid2 in 1 CARTONTABLET211
63981-986-44Sleep Aid96 in 1 BOTTLE, PLASTICTABLET9611
63981-986-96Sleep Aid2 in 1 PACKAGETABLET211
63981-986-96Sleep Aid96 in 1 BOTTLE, PLASTICTABLET9611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-986-96EA - Each63981-9860b26f678-a9c9-4e3c-aa92-9b748463844912019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-986SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [COSTCO WHOLESALE CORPORATION]10Current NDC, Legacy NDC, 4 package rows20240825_74a728e1-9ca1-4219-9427-b503ab0480b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN74a728e1-9ca1-4219-9427-b503ab0480b411
1101446doxylamine succinate 25 MG Oral TabletSCD74a728e1-9ca1-4219-9427-b503ab0480b411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63981-986-44639810986442 BOTTLE in 1 CARTON (63981-986-44) > 96 TABLET in 1 BOTTLE2 bottle2019-05-032021-05-16NoNoCurrent
63981-986-96639810986962 BOTTLE, PLASTIC in 1 PACKAGE (63981-986-96) / 96 TABLET in 1 BOTTLE, PLASTIC2019-05-030000-00-00NoNoCurrent