Home NDC 60687-830 Diphenhydramine HCl
Product NDC 60687-830
11-digit product format 606870830
Labeler code 60687
Product ID 60687-830_1c81b131-ccf6-49a7-e063-6394a90a9695
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler American Health Packaging
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-04
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 mg/10mL
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 25 mg/10mL
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 60687-830-08 Diphenhydramine HCl 3 in 1 CASE SOLUTION 3 1 60687-830-42 Diphenhydramine HCl 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 1 60687-830-48 Diphenhydramine HCl 10 in 1 TRAY SOLUTION 10 1 60687-830-56 Diphenhydramine HCl 10 in 1 CASE SOLUTION 10 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-830 DIPHENHYDRAMINE HCL (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AMERICAN HEALTH PACKAGING] 1 Current NDC, 4 package rows 20240807_b94feeb6-f33f-410d-a9b0-776b1ccf34a9.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 73 of 178 · 3,551 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 60687-830-08 60687083008 3 TRAY in 1 CASE (60687-830-08) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-830-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-830-42) 3 tray 2024-08-04 No No Current 60687-830-42 60687083042 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 60687-830-48 60687083048 10 in 1 TRAY Historical 60687-830-56 60687083056 10 TRAY in 1 CASE (60687-830-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-830-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-830-42) 10 tray 2024-08-04 No No Current