Sleep Aid

Product NDC
36800-672
11-digit product format
368000672
Labeler code
36800
Product ID
36800-672_cc763156-e5c5-4101-9584-5f63ac4d0907
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates, LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-24
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
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
36800-672-06Sleep Aid200 in 1 BOTTLETABLET, FILM COATED20012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-672SLEEP AID (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [TOPCO ASSOCIATES, LLC]11Current NDC, Legacy NDC, 1 package rows20240621_57a81e24-ef0d-4143-b266-71e2d4be7617.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN57a81e24-ef0d-4143-b266-71e2d4be761712
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD57a81e24-ef0d-4143-b266-71e2d4be761712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-672-0636800067206200 TABLET, FILM COATED in 1 BOTTLE (36800-672-06) 2015-07-240000-00-00NoNoCurrent