Sleep Aid

Product NDC
0363-0386
11-digit product format
003630386
Labeler code
0363
Product ID
0363-0386_d1c23648-ab41-4db2-aaf2-d0f3fabd0aa2
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
Walgreen Company
Application
ANDA040564
Marketing category
ANDA
Marketing start
2024-04-05
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

Additional Listing Data#

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

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
0363-0386-12Sleep Aid1 in 1 CARTONTABLET15
0363-0386-12Sleep Aid100 in 1 BOTTLE, PLASTICTABLET1005
0363-0386-22Sleep Aid16 in 1 BLISTER PACKTABLET165
0363-0386-22Sleep Aid3 in 1 CARTONTABLET35
0363-0386-31Sleep Aid80 in 1 BOTTLE, PLASTICTABLET805
0363-0386-31Sleep Aid1 in 1 CARTONTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0386SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [WALGREEN COMPANY]4Current NDC, 6 package rows20250206_d812217b-b2f2-4716-92f4-c16bd0768e17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSNd812217b-b2f2-4716-92f4-c16bd0768e175
1101446doxylamine succinate 25 MG Oral TabletSCDd812217b-b2f2-4716-92f4-c16bd0768e175

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-0386-12003630386121 BOTTLE, PLASTIC in 1 CARTON (0363-0386-12) / 100 TABLET in 1 BOTTLE, PLASTIC2024-12-31NoNoHistorical
0363-0386-22003630386223 BLISTER PACK in 1 CARTON (0363-0386-22) / 16 TABLET in 1 BLISTER PACK3 blister pack2024-04-05NoNoHistorical
0363-0386-31003630386311 BOTTLE, PLASTIC in 1 CARTON (0363-0386-31) / 80 TABLET in 1 BOTTLE, PLASTIC2024-04-05NoNoHistorical