Home NDC 84379-286 REVASOL CHILDRENS ALLERGY
Product NDC 84379-286
11-digit product format 843790286
Labeler code 84379
Product ID 84379-286_3143137f-ef43-5358-e063-6394a90a8ed1
Type HUMAN OTC DRUG
Nonproprietary name DIPHENHYDRAMINE HCL
Dosage form LIQUID
Route ORAL
Labeler Rnv LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-12
Substance DIPHENHYDRAMINE HCL
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 REVASOL CHILDRENS ALLERGY
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HCL 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 84379-286-04 REVASOL CHILDRENS ALLERGY 118 mL in 1 BOTTLE LIQUID 118 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84379-286 REVASOL CHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) LIQUID [RNV LLC] 1 Current NDC, 1 package rows 20250330_3143137f-ef42-5358-e063-6394a90a8ed1.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 84379-286-04 84379028604 118 mL in 1 BOTTLE (84379-286-04) 118 ml 2025-02-12 No No Current