Nighttime Sleep Aid

Product NDC
69168-446
11-digit product format
691680446
Labeler code
69168
Product ID
69168-446_88fee002-990d-4311-a3a6-2f8ed1fb6579
Type
HUMAN OTC DRUG
Nonproprietary name
Nighttime Sleep Aid
Dosage form
LIQUID
Route
ORAL
Labeler
Allegiant Health
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-16
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/30mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1248354

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-446-39Nighttime Sleep Aid354 mL in 1 BOTTLELIQUID3543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-446NIGHTTIME SLEEP AID LIQUID [ALLEGIANT HEALTH]2Current NDC, 1 package rows20240126_88feea1d-c961-45e9-b9a6-1418b970aaba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248354diphenhydrAMINE HCl 50 MG in 30 mL Oral SolutionPSN88feea1d-c961-45e9-b9a6-1418b970aaba3
1248354diphenhydramine hydrochloride 1.67 MG/ML Oral SolutionSCD88feea1d-c961-45e9-b9a6-1418b970aaba3
1248354diphenhydramine HCl 1.667 MG/ML Oral SolutionSY88feea1d-c961-45e9-b9a6-1418b970aaba3
1248354diphenhydramine HCl 50 MG per 30 ML Oral SolutionSY88feea1d-c961-45e9-b9a6-1418b970aaba3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-446-3969168044639354 mL in 1 BOTTLE (69168-446-39) 354 ml2024-01-16NoNoHistorical