Sleep Aid

Product NDC
41250-986
11-digit product format
412500986
Labeler code
41250
Product ID
41250-986_34be9734-68c0-453f-afc4-7103d2e9fc48
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine Succinate
Dosage form
TABLET
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA040564
Marketing category
ANDA
Marketing start
2019-05-06
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
41250-986-22Sleep Aid3 in 1 CARTONTABLET311
41250-986-22Sleep Aid16 in 1 BLISTER PACKTABLET1611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41250-986-22EA - Each41250-986f6ba7eb9-8c4f-4c2f-a2bd-cb54896e5ea412024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-986SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MEIJER DISTRIBUTION INC]10Current NDC, Legacy NDC, 2 package rows20250321_96a7c284-4666-4dac-b71e-9433f62580ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN96a7c284-4666-4dac-b71e-9433f62580ad11
1101446doxylamine succinate 25 MG Oral TabletSCD96a7c284-4666-4dac-b71e-9433f62580ad11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-986-22412500986223 BLISTER PACK in 1 CARTON (41250-986-22) / 16 TABLET in 1 BLISTER PACK3 blister pack2019-05-060000-00-00NoNoCurrent