FDA.reportPublic FDA data

Nighttime Sleep Aid

Product NDC
69168-439
11-digit product format
691680439
Labeler code
69168
Product ID
69168-439_8accb0e9-d994-4b6a-acc3-4b416f3f65ba
Type
HUMAN OTC DRUG
Nonproprietary name
Nighttime Sleep Aid
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
ANDA040564
Marketing category
ANDA
Marketing start
2023-05-16
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
Nighttime 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
69168-439-06Nighttime Sleep Aid120 in 1 BOTTLETABLET1203
69168-439-40Nighttime Sleep Aid40 in 1 BOTTLETABLET403
69168-439-84Nighttime Sleep Aid8 in 1 BLISTER PACKTABLET83
69168-439-84Nighttime Sleep Aid2 in 1 CARTONTABLET23
69168-439-98Nighttime Sleep Aid200 in 1 BOTTLETABLET2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-439NIGHTTIME SLEEP AID TABLET [ALLEGIANT HEALTH]3Current NDC, 5 package rows20231107_3761182c-275b-40f3-a262-9ef5f5a80723.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1101446doxylamine succinate 25 MG Oral TabletPSN3761182c-275b-40f3-a262-9ef5f5a807233
1101446doxylamine succinate 25 MG Oral TabletSCD3761182c-275b-40f3-a262-9ef5f5a807233

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-439-0669168043906120 TABLET in 1 BOTTLE (69168-439-06) 120 tablet2023-05-16NoNoHistorical
69168-439-406916804394040 TABLET in 1 BOTTLE (69168-439-40) 40 tablet2023-11-06NoNoHistorical
69168-439-84691680439842 BLISTER PACK in 1 CARTON (69168-439-84) / 8 TABLET in 1 BLISTER PACK2 blister pack2023-05-16NoNoHistorical
69168-439-9869168043998200 TABLET in 1 BOTTLE (69168-439-98) 200 tablet2023-11-06NoNoHistorical