Nighttime Sleep-Aid

Product NDC
69452-451
11-digit product format
694520451
Labeler code
69452
Product ID
69452-451_44e7d174-6100-5d9b-e063-6294a90aa6d5
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
BIONPHARMA INC.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-01
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-451-22Nighttime Sleep-Aid120 in 1 BOTTLECAPSULE, LIQUID FILLED1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-451NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [BIONPHARMA INC.]1Current NDC, 1 package rows20241003_1f74e760-9ba9-ac47-e063-6394a90acdff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN1f74e760-9ba9-ac47-e063-6394a90acdff2
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD1f74e760-9ba9-ac47-e063-6394a90acdff2
1020477diphenhydramine HCl 50 MG Oral CapsuleSY1f74e760-9ba9-ac47-e063-6394a90acdff2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69452-451-2269452045122120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-451-22) 2024-10-01NoNoCurrent