Home NDC 54859-837 Allergy Relief
Product NDC 54859-837
11-digit product format 548590837
Labeler code 54859
Product ID 54859-837_4745dfbc-e512-5953-e063-6394a90a3b26
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form LIQUID
Route ORAL
Labeler LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-01
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/5mL
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 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 Allergy Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
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 1049906 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 54859-837-04 Allergy Relief 118 mL in 1 BOTTLE LIQUID 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54859-837 ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 1 Current NDC, 1 package rows 20241228_2a46ea9b-29e9-5197-e063-6394a90abc73.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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 54859-837-04 54859083704 118 mL in 1 BOTTLE (54859-837-04) 118 ml 2024-12-01 No No Current