nighttime sleep aid

Product NDC
42507-033
11-digit product format
425070033
Labeler code
42507
Product ID
42507-033_cb5d207d-c077-48df-92d2-a27ef29b73bd
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
HyVee Inc
Application
ANDA040167
Marketing category
ANDA
Marketing start
2014-12-04
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
nighttime 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
42507-033-64nighttime sleep aid1 in 1 BLISTER PACKTABLET14
42507-033-64nighttime sleep aid32 in 1 CARTONTABLET324
42507-033-73nighttime sleep aid16 in 1 CARTONTABLET164
42507-033-73nighttime sleep aid1 in 1 BLISTER PACKTABLET14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN95b12a14-21ee-431d-a892-46f8cdca2d7a4
1101446doxylamine succinate 25 MG Oral TabletSCD95b12a14-21ee-431d-a892-46f8cdca2d7a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-033-644250700336432 BLISTER PACK in 1 CARTON (42507-033-64) / 1 TABLET in 1 BLISTER PACK32 blister pack2026-02-25NoNoCurrent
42507-033-734250700337316 in 1 CARTONHistorical