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

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 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
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

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