Nighttime sleep aid

Product NDC
42829-950
11-digit product format
428290950
Labeler code
42829
Product ID
42829-950_357e8259-0202-c589-e063-6394a90abf8f
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
ASCENT CONSUMER PRODUCTS, INC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-16
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
42829-950-20Nighttime sleep aid120 in 1 BOTTLECAPSULE, LIQUID FILLED1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42829-950NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [ASCENT CONSUMER PRODUCTS, INC]1Current NDC, 1 package rows20250521_357e8259-0201-c589-e063-6394a90abf8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN357e8259-0201-c589-e063-6394a90abf8f1
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD357e8259-0201-c589-e063-6394a90abf8f1
1020477diphenhydramine HCl 50 MG Oral CapsuleSY357e8259-0201-c589-e063-6394a90abf8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42829-950-2042829095020120 CAPSULE, LIQUID FILLED in 1 BOTTLE (42829-950-20) 2025-05-16NoNoCurrent