FDA.reportPublic FDA data

Sleep Aid

Product NDC
76168-015
11-digit product format
761680015
Labeler code
76168
Product ID
76168-015_6c311047-4bf2-44ad-e053-2a91aa0ad047
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Velocity Pharma LLC
Application
part338
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-05-14
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 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
035454a1-d23b-4faf-8fac-a59fc77ce18cAvailable 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
76168-015-07Sleep Aid1 in 1 CARTONTABLET, FILM COATED13
76168-015-07Sleep Aid36 in 1 BOTTLETABLET, FILM COATED363
76168-015-12Sleep Aid100 in 1 BOTTLETABLET, FILM COATED1003
76168-015-12Sleep Aid1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-015SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [VELOCITY PHARMA LLC]3Current NDC, Legacy NDC, 4 package rows20180515_035454a1-d23b-4faf-8fac-a59fc77ce18c.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEVelocity Pharma LLC035454a1-d23b-4faf-8fac-a59fc77ce18c2018-05-14WarningsExact identifier
ndc (product): 76168-015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN035454a1-d23b-4faf-8fac-a59fc77ce18c3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD035454a1-d23b-4faf-8fac-a59fc77ce18c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76168-015-07761680015071 BOTTLE in 1 CARTON (76168-015-07) / 36 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-05-140000-00-00NoNoCurrent
76168-015-12761680015121 BOTTLE in 1 CARTON (76168-015-12) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-05-140000-00-00NoNoCurrent