Home NDC 69618-025 Diphenhydramine HCL 25 mg
Product NDC 69618-025
11-digit product format 696180025
Labeler code 69618
Product ID 69618-025_2bc8473d-acff-da1d-e063-6394a90ae0d4
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCL
Dosage form TABLET
Route ORAL
Labeler Reliable 1 Laboratories LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-11-01
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 Diphenhydramine HCL 25 mg
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69618-025-01 Diphenhydramine HCL 25 mg 100 in 1 BOTTLE, PLASTIC TABLET 100 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69618-025 DIPHENHYDRAMINE HCL 25 MG (DIPHENHYDRAMINE HCL) TABLET [RELIABLE 1 LABORATORIES LLC] 7 Current NDC, Legacy NDC, 1 package rows 20250117_32f58cb3-941f-263b-e054-00144ff8d46c.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 99 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 69618-025-01 69618002501 100 TABLET in 1 BOTTLE, PLASTIC (69618-025-01) 100 tablet 2015-11-01 0000-00-00 No No Current