Home NDC 87078-421 OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)
Product NDC 87078-421
11-digit product format 870780421
Labeler code 87078
Product ID 87078-421_4157b5d8-b6fa-c9ce-e063-6394a90a784c
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form SOLUTION
Route ORAL
Labeler MEDWISE LIFESCIENCES INC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-06
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 OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry)
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 87078-421-52 OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry) 5 mL in 1 POUCH SOLUTION 5 1 87078-421-52 OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution (Cherry) 12 in 1 CARTON SOLUTION 12 1
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 123 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 87078-421-52 87078042152 12 POUCH in 1 CARTON (87078-421-52) / 5 mL in 1 POUCH 12 pouch 2025-10-17 No No Current