Home NDC 84415-012 Diphenhydramine HCl Oral Solution
Product NDC 84415-012
11-digit product format 844150012
Labeler code 84415
Product ID 84415-012_2bd97cb8-2b08-aa8d-e063-6394a90ad19d
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl Oral
Dosage form SOLUTION
Route ORAL
Labeler Everpharm LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-16
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 Diphenhydramine HCl Oral Solution
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 84415-012-01 Diphenhydramine HCl Oral Solution 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 1 84415-012-01 Diphenhydramine HCl Oral Solution 100 in 1 BOX, UNIT-DOSE SOLUTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84415-012 DIPHENHYDRAMINE HCL ORAL SOLUTION (DIPHENHYDRAMINE HCL ORAL) SOLUTION [EVERPHARM LLC] 1 Current NDC, 2 package rows 20250119_d7aaf874-69ac-49cf-93be-6d4a38b9a557.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 97 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 84415-012-01 84415001201 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (84415-012-01) / 5 mL in 1 CUP, UNIT-DOSE 2025-01-16 No No Current