Sleep-Aid

Product NDC
70000-0567
11-digit product format
700000567
Labeler code
70000
Product ID
70000-0567_8b3b9de1-0b79-4cd4-bba9-aa6b49151594
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 110, LLC. DBA Leader
Application
ANDA040564
Marketing category
ANDA
Marketing start
2020-07-23
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
70000-0567-1Sleep-Aid3 in 1 CARTONTABLET38
70000-0567-1Sleep-Aid16 in 1 BLISTER PACKTABLET168

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0567SLEEP-AID (DOXYLAMINE SUCCINATE) TABLET [CARDINAL HEALTH 110, LLC. DBA LEADER]7Current NDC, Legacy NDC, 2 package rows20240718_96e8d6df-e717-4ffc-9502-498024c9665f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN96e8d6df-e717-4ffc-9502-498024c9665f8
1101446doxylamine succinate 25 MG Oral TabletSCD96e8d6df-e717-4ffc-9502-498024c9665f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0567-1700000567013 BLISTER PACK in 1 CARTON (70000-0567-1) / 16 TABLET in 1 BLISTER PACK3 blister pack2020-07-230000-00-00NoNoCurrent