Home NDC 78691-028 Biopure
Product NDC 78691-028
11-digit product format 786910028
Labeler code 78691
Product ID 78691-028_3a3c0aa0-7504-7ef0-e063-6294a90a9f94
Type HUMAN OTC DRUG
Nonproprietary name Hand Sanitizer Spray
Dosage form LIQUID
Route TOPICAL
Labeler Quest USA Corp
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-15
Substance ALCOHOL
Active strength 16 g/30mL
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCOHOL 16 g/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3K9958V90M Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78691-028-01 Biopure 30 mL in 1 BOTTLE, SPRAY LIQUID 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78691-028 BIOPURE (HAND SANITIZER SPRAY) LIQUID [QUEST USA CORP] 1 Current NDC, 1 package rows 20250416_3249f563-7968-e512-e063-6394a90aad52.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 44 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 78691-028-01 78691002801 30 mL in 1 BOTTLE, SPRAY (78691-028-01) 30 ml 2025-04-15 No No Current