Nighttime Sleep-Aid

Product NDC
63941-683
11-digit product format
639410683
Labeler code
63941
Product ID
63941-683_0788c3b6-d878-b337-e063-6294a90acd3a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
VALU MERCHANDISERS COMPANY
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-12
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1020477

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
63941-683-17Nighttime Sleep-Aid1 in 1 CARTONCAPSULE, LIQUID FILLED12
63941-683-17Nighttime Sleep-Aid60 in 1 BOTTLECAPSULE, LIQUID FILLED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-683NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [VALU MERCHANDISERS COMPANY]2Current NDC, 2 package rows20231013_fed2f7ae-2829-f967-e053-6294a90adc0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNfed2f7ae-2829-f967-e053-6294a90adc0a2
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDfed2f7ae-2829-f967-e053-6294a90adc0a2
1020477diphenhydramine HCl 50 MG Oral CapsuleSYfed2f7ae-2829-f967-e053-6294a90adc0a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63941-683-17639410683171 BOTTLE in 1 CARTON (63941-683-17) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2023-10-12NoNoHistorical