Sleep Aid

Product NDC
55319-367
11-digit product format
553190367
Labeler code
55319
Product ID
55319-367_ca5419cb-5e17-48ed-97ab-7b48dab5482f
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Family Dollar Services Inc
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-06-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Aid
Brand name suffix
Nighttime
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
55319-367-08Sleep AidNighttime2 in 1 CARTONTABLET, FILM COATED212
55319-367-08Sleep AidNighttime12 in 1 BLISTER PACKTABLET, FILM COATED1212
55319-367-12Sleep AidNighttime100 in 1 BOTTLETABLET, FILM COATED10012
55319-367-12Sleep AidNighttime1 in 1 CARTONTABLET, FILM COATED112

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]5
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]5
TALCINACTIVE INGREDIENT7SEV7J4R1USLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-367SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [FAMILY DOLLAR SERVICES INC]11Current NDC, Legacy NDC, 4 package rows20250519_8ebd9949-ef53-4d66-a20c-3e0047b3e1ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN8ebd9949-ef53-4d66-a20c-3e0047b3e1ef12
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD8ebd9949-ef53-4d66-a20c-3e0047b3e1ef12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-367-08553190367082 BLISTER PACK in 1 CARTON (55319-367-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2000-06-10NoNoCurrent
55319-367-12553190367121 BOTTLE in 1 CARTON (55319-367-12) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2000-06-102026-11-30NoNoHistorical