Nighttime Sleep Aid

Product NDC
83324-110
11-digit product format
833240110
Labeler code
83324
Product ID
83324-110_1f7f0883-531e-3dc6-e063-6294a90a3215
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION, INC.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-12
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-110-32Nighttime Sleep Aid4 in 1 CARTONTABLET42
83324-110-32Nighttime Sleep Aid8 in 1 BLISTER PACKTABLET82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-110NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Current NDC, 2 package rows20240814_8d985ad7-71b9-493f-9b9a-d6ef280f72dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN8d985ad7-71b9-493f-9b9a-d6ef280f72dd2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD8d985ad7-71b9-493f-9b9a-d6ef280f72dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-110-32833240110324 BLISTER PACK in 1 CARTON (83324-110-32) / 8 TABLET in 1 BLISTER PACK4 blister pack2024-08-12NoNoCurrent