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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ebd9949-ef53-4d66-a20c-3e0047b3e1efAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 14 · 263 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wal Som Nighttime Sleep AidDIPHENHYDRAMINE HCLWalgreensff475a69-dbb2-40a9-b7f4-9c7b7e975d192026-07-23WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporation336ac29d-db24-44da-a299-5a4793ae8f6a2026-07-21WarningsExact identifier
application number: M010
Best Choice Childrens Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLBEST CHOICE (VALU MERCHANDISERS COMPANY)9bf2d698-8394-46c3-b7a9-e99ab6bb88e42026-07-17WarningsExact identifier
application number: M010
ADWE dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDERARITAN PHARMACEUTICALS INCea3a51af-3025-497f-8cd7-e99391b0d06f2026-07-17WarningsExact identifier
application number: M010
nighttime sleep aidDIPHENHYDRAMINE HCLAmazon.com Services LLCa8056e5f-e9d8-4555-9212-bf1fa3c154392026-07-16WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLAmerisource Bergen147adc14-ca7c-45f5-9925-ea569edbfe962026-07-09WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCL 25 MGHealth Pharma USA LLCd659f747-9790-8bd6-e053-2995a90ae7932026-07-07WarningsExact identifier
application number: M010
PharbedrylDIPHENHYDRAMINE HCLSt. Mary's Medical Park Pharmacy3ef18965-bafb-cc19-e063-6394a90af17d2026-06-29WarningsExact identifier
application number: M010
CalmCo Sleep AidDIPHENHYDRAMINE HCLCalmCo LLC552d0e50-a58c-8e47-e063-6394a90a8f7b2026-06-26WarningsExact identifier
application number: M010
Vicks ZzzQuil Night PainDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENThe Procter & Gamble Manufacturing Companya7cf8e2e-7aac-a1fa-e053-2a95a90a561a2026-06-26WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLBi-Mart1b40e794-089f-4546-8f8d-ba7016cd4e7f2026-06-22WarningsExact identifier
application number: M010
Sleep-AidDIPHENHYDRAMINE HCLRite Aid Corporation1a5668df-2bbc-4724-af39-19d30a8920f32026-06-22WarningsExact identifier
application number: M010
Sleep Aid Night TimeDIPHENHYDRAMINE HCLDOLGENCORP, LLC9f1e2e1f-d3e8-4c8a-9e3e-c2ab9e4c79e82026-06-16WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLTopco Associates, LLC57a81e24-ef0d-4143-b266-71e2d4be76172026-06-16WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLCVS Pharmacy3710254e-6c3c-4044-9694-59703274cd0f2026-06-15WarningsExact identifier
application number: M010
Sleep Aid NighttimeDIPHENHYDRAMINE HCLWal-Mart Stores Inccfddfdeb-701f-452d-876d-8003e6fcefe32026-06-15WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLFamily Dollar Services Inc2d63400b-43ae-4dd2-b917-3f65e02366b42026-06-08WarningsExact identifier
application number: M010
MantraMANTRA SLEEP AID WILD CHERRYMOREMED INC.316d11fe-a173-a1dd-e063-6394a90af4992026-05-21WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HCLTOPCO ASSOCIATES LLC9558cc42-d27d-42af-b0a7-44cad025165d2026-05-21WarningsExact identifier
application number: M010
Sleep Aid NightTimeDIPHENHYDRAMINE HCLWal-Mart Stores Incdac2a0b9-f851-467b-a39f-3560d42c96e22026-05-20WarningsExact identifier
application number: M010

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