Sleep Aid

Product NDC
41163-986
11-digit product format
411630986
Labeler code
41163
Product ID
41163-986_67863f1b-c028-41f8-8980-05c9452c215a
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine Succinate
Dosage form
TABLET
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA040564
Marketing category
ANDA
Marketing start
2019-06-30
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
41163-986-22Sleep Aid3 in 1 CARTONTABLET39
41163-986-22Sleep Aid16 in 1 BLISTER PACKTABLET169

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-986SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [UNITED NATURAL FOODS, INC. DBA UNFI]8Current NDC, Legacy NDC, 2 package rows20250428_005b5ad8-d762-46b5-a7a5-e0ff11ba936a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN005b5ad8-d762-46b5-a7a5-e0ff11ba936a9
1101446doxylamine succinate 25 MG Oral TabletSCD005b5ad8-d762-46b5-a7a5-e0ff11ba936a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-986-22411630986223 BLISTER PACK in 1 CARTON (41163-986-22) / 16 TABLET in 1 BLISTER PACK3 blister pack2019-06-300000-00-00NoNoCurrent