Sleep Aid

Product NDC
55910-614
11-digit product format
559100614
Labeler code
55910
Product ID
55910-614_0d12ff8b-e733-4a27-be23-e3c3294fbdf0
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DOLGENCORP, LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-10
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
55910-614-12Sleep Aid1 in 1 CARTONTABLET, FILM COATED13
55910-614-12Sleep Aid100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-614SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]2Current NDC, 2 package rows20240816_2bb3016a-2e03-43fe-a655-45d4ec872c79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2bb3016a-2e03-43fe-a655-45d4ec872c793
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2bb3016a-2e03-43fe-a655-45d4ec872c793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55910-614-12559100614121 BOTTLE, PLASTIC in 1 CARTON (55910-614-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2024-07-10NoNoCurrent