Nighttime Sleep Aid

Product NDC
69842-386
11-digit product format
698420386
Labeler code
69842
Product ID
69842-386_056affe0-8a11-46fd-bd74-50bcce610b91
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine succinate
Dosage form
TABLET
Route
ORAL
Labeler
CVS PHARMACY
Application
ANDA040564
Marketing category
ANDA
Marketing start
2019-07-20
Marketing end
2028-04-30
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
Nighttime 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
69842-386-22Nighttime Sleep Aid16 in 1 BLISTER PACKTABLET169
69842-386-22Nighttime Sleep Aid3 in 1 CARTONTABLET39
69842-386-96Nighttime Sleep Aid96 in 1 BOTTLETABLET969
69842-386-96Nighttime Sleep Aid2 in 1 CARTONTABLET29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-386NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [CVS PHARMACY]8Current NDC, Legacy NDC, 4 package rows20240825_0b08ca81-1d07-4a57-9cbd-72e3a6a37814.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN0b08ca81-1d07-4a57-9cbd-72e3a6a378149
1101446doxylamine succinate 25 MG Oral TabletSCD0b08ca81-1d07-4a57-9cbd-72e3a6a378149

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-386-22698420386223 BLISTER PACK in 1 CARTON (69842-386-22) / 16 TABLET in 1 BLISTER PACK3 blister pack2019-07-202028-04-30NoNoCurrent
69842-386-96698420386962 BOTTLE in 1 CARTON (69842-386-96) > 96 TABLET in 1 BOTTLE2 bottle2019-07-200000-00-00NoNoCurrent