Home NDC 0121-0865 Diphenhydramine HCl
Product NDC 0121-0865
11-digit product format 001210865
Labeler code 0121
Product ID 0121-0865_d56f4fe1-e90c-4e35-a488-12c93938a3dd
Type HUMAN OTC DRUG
Nonproprietary name diphenhydramine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-06-18
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 0121-0865-00 Diphenhydramine HCl 10 in 1 CASE SOLUTION 10 5 0121-0865-00 Diphenhydramine HCl 10 in 1 TRAY SOLUTION 10 5 0121-0865-05 Diphenhydramine HCl 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 5 0121-0865-30 Diphenhydramine HCl 10 in 1 TRAY SOLUTION 10 5 0121-0865-30 Diphenhydramine HCl 3 in 1 CASE SOLUTION 3 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0865 DIPHENHYDRAMINE HCL (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 5 Current NDC, Legacy NDC, 5 package rows 20240911_3c3e0dc8-cddd-4f46-9b68-19bac00c07cc.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 Marketing end Sample Exclude flag Status 0121-0865-00 00121086500 10 TRAY in 1 CASE (0121-0865-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05) 10 tray 2020-06-18 0000-00-00 No No Current 0121-0865-05 00121086505 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 0121-0865-30 00121086530 3 TRAY in 1 CASE (0121-0865-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0865-05) 3 tray 2020-06-18 0000-00-00 No No Current