Nighttime Sleep-aid

Product NDC
80136-785
11-digit product format
801360785
Labeler code
80136
Product ID
80136-785_352f4b78-30e7-e864-e063-6394a90a8ace
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET
Route
ORAL
Labeler
NORTHEAST PHARMA
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-01
Marketing end
2026-12-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nighttime Sleep-aid

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
80136-785-96Nighttime Sleep-aid96 in 1 BOTTLETABLET963

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80136-785NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) TABLET [NORTHEAST PHARMA]3Current NDC, Legacy NDC, 1 package rows20250516_d2062094-d1b5-38ab-e053-2995a90a5670.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNd2062094-d1b5-38ab-e053-2995a90a56703
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDd2062094-d1b5-38ab-e053-2995a90a56703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80136-785-968013607859696 TABLET in 1 BOTTLE (80136-785-96) 96 tablet2021-09-012026-12-31NoNoCurrent