sleep aid ultra

Product NDC
79481-0096
11-digit product format
794810096
Labeler code
79481
Product ID
79481-0096_d802f1ad-a820-42ba-8bd6-b35499deb7a2
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine Succinate
Dosage form
TABLET
Route
ORAL
Labeler
Meijer, Inc.
Application
ANDA040167
Marketing category
ANDA
Marketing start
2022-07-29
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 ultra
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
79481-0096-0sleep aid ultra24 in 1 CARTONTABLET244
79481-0096-0sleep aid ultra1 in 1 BLISTER PACKTABLET14
79481-0096-1sleep aid ultra12 in 1 CARTONTABLET124
79481-0096-1sleep aid ultra1 in 1 BLISTER PACKTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0096SLEEP AID ULTRA (DOXYLAMINE SUCCINATE) TABLET [MEIJER, INC.]3Current NDC, Legacy NDC, 4 package rows20250306_792632af-01c1-4a9b-99f4-8eb84d0fc389.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN792632af-01c1-4a9b-99f4-8eb84d0fc3894
1101446doxylamine succinate 25 MG Oral TabletSCD792632af-01c1-4a9b-99f4-8eb84d0fc3894

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79481-0096-07948100960024 BLISTER PACK in 1 CARTON (79481-0096-0) / 1 TABLET in 1 BLISTER PACK24 blister pack2022-07-290000-00-00NoNoCurrent
79481-0096-17948100960112 BLISTER PACK in 1 CARTON (79481-0096-1) / 1 TABLET in 1 BLISTER PACK12 blister pack2025-06-03NoNoCurrent