Home NDC 78280-401 KeriCleanz ANTISEPTIC
Product NDC 78280-401
11-digit product format 782800401
Labeler code 78280
Product ID 78280-401_1236303c-b046-4185-8e10-11c4893cd120
Type HUMAN OTC DRUG
Nonproprietary name Hydrogen Peroxide
Dosage form SPRAY
Route TOPICAL
Labeler Kericure Inc.
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-11
Substance HYDROGEN PEROXIDE
Active strength 1 mL/100mL
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 KeriCleanz ANTISEPTIC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROGEN PEROXIDE 1 mL/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BBX060AN9V Internal UNII 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 78280-401-05 KeriCleanz ANTISEPTIC 17 mL in 1 BOTTLE, SPRAY SPRAY 17 3 78280-401-10 KeriCleanz ANTISEPTIC 28 mL in 1 BOTTLE, SPRAY SPRAY 28 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78280-401 KERICLEANZ ANTISEPTIC (HYDROGEN PEROXIDE) SPRAY [KERICURE INC.] 2 Current NDC, 2 package rows 20250108_79b0d9bb-0fa5-4e45-ab74-9ff0e1215238.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 9 of 115 · 2,286 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 78280-401-05 78280040105 17 mL in 1 BOTTLE, SPRAY (78280-401-05) 17 ml 2025-08-01 No No Current 78280-401-10 78280040110 28 mL in 1 BOTTLE, SPRAY (78280-401-10) 28 ml 2023-10-11 No No Current