Diphenhydramine Hydrochloride

Product NDC
51316-347
11-digit product format
513160347
Labeler code
51316
Product ID
51316-347_1135711a-2949-da66-e063-6394a90ad4f0
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
CVS Pharmacy, Inc
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-02
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
51316-347-05513160347051 BOTTLE in 1 CARTON (51316-347-05) / 120 CAPSULE in 1 BOTTLE1 bottle2023-02-02NoNoHistorical
51316-347-0651316034706365 CAPSULE in 1 BOTTLE (51316-347-06) 365 capsule2023-04-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
5347K-CVSCVS Pharmacy, Inc2024-02-12HUMAN OTC DRUG LABEL2