Home NDC 84324-004 Allergy Relief
Product NDC 84324-004
11-digit product format 843240004
Labeler code 84324
Product ID 84324-004_49deb94f-35ee-4830-aa06-2bf17ebc9138
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl 25 mg
Dosage form TABLET
Route ORAL
Labeler NUVICARE LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-17
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 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 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 1049630 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 84324-004-01 Allergy Relief 300 in 1 BOTTLE TABLET 300 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84324-004 ALLERGY RELIEF (DIPHENHYDRAMINE HCL 25 MG) TABLET [NUVICARE LLC] 2 Current NDC, 1 package rows 20240911_621ba20e-75c5-42fb-9692-7800f764c978.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 Sample Exclude flag Status 84324-004-01 84324000401 300 TABLET in 1 BOTTLE (84324-004-01) 300 tablet 2024-07-17 No No Current