Quality Choice Nighttime Sleep-Aid

Product NDC
63868-970
11-digit product format
638680970
Labeler code
63868
Product ID
63868-970_5ce01eb6-2e0d-4c50-9059-61f5f2a009dd
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-28
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
TC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE147-24-0DIPHENHYDRAMINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63868-970-24638680970242 BLISTER PACK in 1 CARTON (63868-970-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2023-03-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
QUALITY CHOICE Nighttime Sleep-AidChain Drug Marketing Association, Inc.2024-12-16HUMAN OTC DRUG LABEL4