sleep aid

Product NDC
56062-441
11-digit product format
560620441
Labeler code
56062
Product ID
56062-441_2fbd1f60-92db-4bba-ae73-36d0e3c3a8c5
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
Publix Super Markets Inc
Application
ANDA040167
Marketing category
ANDA
Marketing start
2025-05-16
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
56062-441-01sleep aid96 in 1 BOTTLETABLET962
56062-441-01sleep aid1 in 1 CARTONTABLET12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN377ebf03-c1d5-4362-98b3-032206df9e8e2
1101446doxylamine succinate 25 MG Oral TabletSCD377ebf03-c1d5-4362-98b3-032206df9e8e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
56062-441-01560620441011 BOTTLE in 1 CARTON (56062-441-01) / 96 TABLET in 1 BOTTLE1 bottle2025-05-16NoNoHistorical