Sleep Aid

Product NDC
55319-564
11-digit product format
553190564
Labeler code
55319
Product ID
55319-564_c5442ca7-33c3-4a7a-bb13-242ca302b009
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep AidDIPHENHYDRAMINE HCLFamily Dollar (FAMILY WELLNESS)1eb2e4d7-1572-4c0c-888b-342831298cad2025-10-03WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product avoid alcoholic drinks. Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Sleep Aid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1020477

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-564-32Sleep Aid1 in 1 BOXCAPSULE18
55319-564-32Sleep Aid32 in 1 BOTTLE, PLASTICCAPSULE328
55319-564-64Sleep Aid64 in 1 BOTTLE, PLASTICCAPSULE648
55319-564-64Sleep Aid1 in 1 BOXCAPSULE18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-564SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]7Current NDC, 4 package rows20250316_1eb2e4d7-1572-4c0c-888b-342831298cad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN1eb2e4d7-1572-4c0c-888b-342831298cad8
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD1eb2e4d7-1572-4c0c-888b-342831298cad8
1020477diphenhydramine HCl 50 MG Oral CapsuleSY1eb2e4d7-1572-4c0c-888b-342831298cad8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55319-564-32553190564321 BOTTLE, PLASTIC in 1 BOX (55319-564-32) / 32 CAPSULE in 1 BOTTLE, PLASTIC2023-07-01NoNoCurrent
55319-564-64553190564641 BOTTLE, PLASTIC in 1 BOX (55319-564-64) / 64 CAPSULE in 1 BOTTLE, PLASTIC2023-07-01NoNoCurrent