Sleep Aid

Product NDC
84324-016
11-digit product format
843240016
Labeler code
84324
Product ID
84324-016_b27e9072-5af6-4a97-82a7-34ee2698fe2e
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl 25 mg
Dosage form
TABLET
Route
ORAL
Labeler
NUVICARE LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-18
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
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
84324-016-01Sleep Aid200 in 1 BOTTLETABLET2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84324-016SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [NUVICARE LLC]2Current NDC, 1 package rows20240821_85391744-3bf5-428e-a77b-464aa95b3a1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN85391744-3bf5-428e-a77b-464aa95b3a1a3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD85391744-3bf5-428e-a77b-464aa95b3a1a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84324-016-0184324001601200 TABLET in 1 BOTTLE (84324-016-01) 200 tablet2024-07-18NoNoCurrent