sleep aid

Product NDC
0363-3462
11-digit product format
003633462
Labeler code
0363
Product ID
0363-3462_dd20fa8c-fc10-42e0-ab05-415b2a46928d
Type
HUMAN OTC DRUG
Nonproprietary name
doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
Walgreen Company
Application
ANDA040167
Marketing category
ANDA
Marketing start
2025-02-14
Marketing end
2026-10-31
Substance
DOXYLAMINE SUCCINATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
sleep aid

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
0363-3462-80sleep aid1 in 1 CARTONTABLET13
0363-3462-80sleep aid96 in 1 BOTTLETABLET963

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3462SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [WALGREEN COMPANY]2Current NDC, 2 package rows20250228_489ee606-15f4-4032-a62b-35c8844f1a26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN489ee606-15f4-4032-a62b-35c8844f1a263
1101446doxylamine succinate 25 MG Oral TabletSCD489ee606-15f4-4032-a62b-35c8844f1a263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-3462-80003633462801 BOTTLE in 1 CARTON (0363-3462-80) / 96 TABLET in 1 BOTTLE1 bottle2025-02-142026-10-31NoNoHistorical