Nighttime Sleep-Aid

Product NDC
53943-485
11-digit product format
539430485
Labeler code
53943
Product ID
53943-485_44e80efc-6d2a-001d-e063-6394a90ae44c
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
DISCOUNT DRUG MART, INC.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-20
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
53943-485-18Nighttime Sleep-Aid1 in 1 CARTONCAPSULE, LIQUID FILLED13
53943-485-18Nighttime Sleep-Aid64 in 1 BOTTLECAPSULE, LIQUID FILLED643

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-485NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [DISCOUNT DRUG MART, INC.]2Current NDC, 2 package rows20240402_116e8192-0c2f-39ed-e063-6294a90abaf3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN116e8192-0c2f-39ed-e063-6294a90abaf33
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD116e8192-0c2f-39ed-e063-6294a90abaf33
1020477diphenhydramine HCl 50 MG Oral CapsuleSY116e8192-0c2f-39ed-e063-6294a90abaf33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53943-485-18539430485181 BOTTLE in 1 CARTON (53943-485-18) / 64 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-03-20NoNoCurrent