Home NDC 55154-2344 Diphenhydramine Hydrochloride
Product NDC 55154-2344
11-digit product format 551542344
Labeler code 55154
Product ID 55154-2344_afa9d3dc-871c-4443-b467-6867455e2072
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Cardinal Health 107, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-14
Marketing end 2028-02-29
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Diphenhydramine Hydrochloride Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1049909 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55154-2344-0 Diphenhydramine Hydrochloride 1 in 1 BLISTER PACK CAPSULE 1 7 55154-2344-0 Diphenhydramine Hydrochloride 10 in 1 BAG CAPSULE 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-2344 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH 107, LLC] 4 Current NDC, 2 package rows 20241025_5a5c5f33-5b70-465d-a38b-6f518af09788.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55154-2344-0 55154234400 10 BLISTER PACK in 1 BAG (55154-2344-0) / 1 CAPSULE in 1 BLISTER PACK 10 blister pack 2022-04-14 2028-02-29 No No Historical