NIGHTTIME SLEEP AID

Product NDC
37835-812
11-digit product format
378350812
Labeler code
37835
Product ID
37835-812_371d6309-a208-f296-e063-6394a90add92
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Bi-Mart
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
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
NIGHTTIME 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
37835-812-36NIGHTTIME SLEEP AID36 in 1 BOTTLETABLET361

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNe5146569-a42b-43f8-a3d1-4f7bcdaef6f71
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDe5146569-a42b-43f8-a3d1-4f7bcdaef6f71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37835-812-363783508123636 TABLET in 1 BOTTLE (37835-812-36) 36 tablet2025-05-01NoNoHistorical