Sleep Aid

Product NDC
41250-441
11-digit product format
412500441
Labeler code
41250
Product ID
41250-441_e4166421-90cf-4796-b81a-89d3bfc75870
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA040167
Marketing category
ANDA
Marketing start
1997-02-21
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
41250-441-00Sleep Aid96 in 1 BOTTLETABLET965
41250-441-01Sleep Aid1 in 1 CARTONTABLET15
41250-441-64Sleep Aid1 in 1 BLISTER PACKTABLET15
41250-441-64Sleep Aid32 in 1 CARTONTABLET325

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MEIJER DISTRIBUTION INC]3
DOXYLAMINEACTIVE MOIETY95QB77JKPLSLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MEIJER DISTRIBUTION INC]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MEIJER DISTRIBUTION INC]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MEIJER DISTRIBUTION INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MEIJER DISTRIBUTION INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MEIJER DISTRIBUTION INC]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSNde0a6f68-6988-44df-9fab-b87620fd32e85
1101446doxylamine succinate 25 MG Oral TabletSCDde0a6f68-6988-44df-9fab-b87620fd32e85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41250-441-004125004410096 in 1 BOTTLEHistorical
41250-441-01412500441011 BOTTLE in 1 CARTON (41250-441-01) / 96 TABLET in 1 BOTTLE (41250-441-00) 1 bottle2026-03-05NoNoHistorical
41250-441-64412500441641 in 1 BLISTER PACKHistorical