Sleep Aid

Product NDC
55910-687
11-digit product format
559100687
Labeler code
55910
Product ID
55910-687_144313c3-7589-4129-9080-622cbf39d3bc
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
2024-01-04
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Aid
Brand name suffix
Night Time
Listing expiration
2027-12-31

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
55910-687-08Sleep AidNight Time12 in 1 BLISTER PACKTABLET, FILM COATED125
55910-687-08Sleep AidNight Time2 in 1 CARTONTABLET, FILM COATED25
55910-687-22Sleep AidNight Time4 in 1 CARTONTABLET, FILM COATED45
55910-687-22Sleep AidNight Time12 in 1 BLISTER PACKTABLET, FILM COATED125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-687SLEEP AID NIGHT TIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [DOLGENCORP, LLC]4Current NDC, 4 package rows20250112_d805fab3-9dca-497f-bdc6-c8a7b1736109.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNd805fab3-9dca-497f-bdc6-c8a7b17361095
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDd805fab3-9dca-497f-bdc6-c8a7b17361095

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55910-687-08559100687082 BLISTER PACK in 1 CARTON (55910-687-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2024-01-04NoNoHistorical
55910-687-22559100687224 BLISTER PACK in 1 CARTON (55910-687-22) / 12 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack2024-01-04NoNoHistorical