Home NDC 78691-021 Biopure 3 Hydrogen Peroxide
Product NDC 78691-021
11-digit product format 786910021
Labeler code 78691
Product ID 78691-021_36748b5a-867f-a864-e063-6394a90af2db
Type HUMAN OTC DRUG
Nonproprietary name HYDROGEN PEROXIDE
Dosage form LIQUID
Route TOPICAL
Labeler Quest USA Corp
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-02
Substance HYDROGEN PEROXIDE
Active strength 30 mg/mL
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 Biopure 3 Hydrogen Peroxide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROGEN PEROXIDE 30 mg/mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283420 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 78691-021-50 Biopure 3 Hydrogen Peroxide 177 mL in 1 BOTTLE, SPRAY LIQUID 177 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78691-021 BIOPURE 3 HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) LIQUID [QUEST USA CORP] 4 Current NDC, 1 package rows 20241215_1e34d066-f82c-484c-87bf-aa54fb1fac07.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 92 of 115 · 2,286 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 78691-021-50 78691002150 177 mL in 1 BOTTLE, SPRAY (78691-021-50) 177 ml 2025-06-02 No No Current