Sleep Aid

Product NDC
30142-386
11-digit product format
301420386
Labeler code
30142
Product ID
30142-386_f421eddd-76c3-4d05-8035-0c71a1226e28
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
Kroger Company
Application
ANDA040564
Marketing category
ANDA
Marketing start
2021-03-16
Marketing end
2027-08-31
Substance
DOXYLAMINE SUCCINATE
Active strength
25 mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Aid

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
30142-386-27Sleep Aid2 in 1 CARTONTABLET26
30142-386-27Sleep Aid16 in 1 BLISTER PACKTABLET166

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-386SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [KROGER COMPANY]5Current NDC, Legacy NDC, 2 package rows20240814_76e1e49d-eb57-4590-8cf8-91f29dbd15c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN76e1e49d-eb57-4590-8cf8-91f29dbd15c36
1101446doxylamine succinate 25 MG Oral TabletSCD76e1e49d-eb57-4590-8cf8-91f29dbd15c36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-386-27301420386272 BLISTER PACK in 1 CARTON (30142-386-27) / 16 TABLET in 1 BLISTER PACK2 blister pack2021-03-162027-08-31NoNoCurrent