Home NDC 84447-103 Diphenhydramine HCL
Product NDC 84447-103
11-digit product format 844470103
Labeler code 84447
Product ID 84447-103_3765beab-e853-b34f-e063-6394a90ac9d5
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCL
Dosage form SOLUTION
Route ORAL
Labeler Belleview Biosciences
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-20
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
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 84447-103-01 Diphenhydramine HCL 200000 mL in 1 DRUM SOLUTION 200000 2 84447-103-04 Diphenhydramine HCL 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 2 84447-103-16 Diphenhydramine HCL 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84447-103 DIPHENHYDRAMINE HCL SOLUTION [BELLEVIEW BIOSCIENCES] 1 Current NDC, 3 package rows 20241109_1db57d86-39f0-f8ca-e063-6394a90a6397.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 84447-103-01 84447010301 200000 mL in 1 DRUM (84447-103-01) 200000 ml 2024-07-20 No No Current 84447-103-04 84447010304 118 mL in 1 BOTTLE, PLASTIC (84447-103-04) 118 ml 2024-07-20 No No Current 84447-103-16 84447010316 473 mL in 1 BOTTLE, PLASTIC (84447-103-16) 473 ml 2024-07-20 No No Current