FDA.reportPublic FDA data

Biopure

Product NDC
78691-027
11-digit product format
786910027
Labeler code
78691
Product ID
78691-027_323c6208-ea9b-92d9-e063-6294a90a8ff1
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
IngredientStrength
ALCOHOL16 g/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
323c61fd-adee-393c-e063-6394a90a5eb3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78691-027-01Biopure30 mL in 1 BOTTLE, SPRAYLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78691-027BIOPURE (HAND SANITIZER SPRAY) LIQUID [QUEST USA CORP]1Current NDC, 1 package rows20250416_323c61fd-adee-393c-e063-6394a90a5eb3.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 96 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DK12 Shower Gel Fresh EnergyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.05e4ff0e-ef63-ef3b-e063-6294a90aa2b82024-12-02WarningsExact identifier
application number: M003
DK12 Vitamin E Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe9270c0-bf6b-f0ff-e053-6394a90ae8f12024-12-02WarningsExact identifier
application number: M003
DK12 Liquid Hand CreamyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.01e2e51b-212b-368e-e063-6294a90a871c2024-12-02WarningsExact identifier
application number: M003
DK12 Fresh Energy Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe80635d-9594-abf3-e053-6394a90aa78b2024-12-02WarningsExact identifier
application number: M003
DK12 Shower Gel CreamyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.05e36111-ed4e-12de-e063-6294a90af6392024-12-02WarningsExact identifier
application number: M003
DK12 Creamy Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe7fde7e-82fc-c13f-e053-6394a90aff682024-12-02WarningsExact identifier
application number: M003
DK12 Oatmeal Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe16387b-1b16-1f41-e053-6294a90ae2c02024-12-02WarningsExact identifier
application number: M003
First Aid Antiseptic Isopropyl Alcohol PadISOPROPYL ALCOHOLFourstar Group USA, Inc.27edf5dc-3e68-bdd0-e063-6394a90ac4852024-11-27WarningsExact identifier
application number: M003
MicroKlenz AntimicrobialBENZETHONIUM CHLORIDEMedline Industries, LP115dda08-709c-490a-9693-419b514419602024-11-26WarningsExact identifier
application number: M003
First Aid Only Alcohol Antiseptic PadALCOHOL PADAcme United Corporation55421010-d806-4ca4-e054-00144ff88e882024-11-26WarningsExact identifier
application number: M003
First Aid Only Hydrogen Peroxide 3%HYDROGEN PEROXIDEAcme United Corporationnf1db8929-9b95-0d6e-e053-2995a90a817f2024-11-26WarningsExact identifier
application number: M003
First Aid Only Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLAcme United Corporationd71047f6-1353-c758-e053-2995a90a962c2024-11-26WarningsExact identifier
application number: M003
First Aid Only Alcohol Antiseptic PadISOPROPYL ALCOHOLAcme United Coporationa01fec1b-1339-40b9-e053-2995a90aeda52024-11-23WarningsExact identifier
application number: M003
Med-Nap Sterile Alcohol Prep PadsISOPROPYL ALCOHOLAcme United Corporationc6eff57b-d537-69c8-e053-2a95a90adc3a2024-11-23WarningsExact identifier
application number: M003
First Aid Only Alcohol AntisepticISOPROPYL ALCOHOLAcme United Corporationa810e723-ad0c-8c71-e053-2995a90a0acc2024-11-23WarningsExact identifier
application number: M003
Universal 50% Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC0dcc9bd2-aea5-4c27-9956-47d56221726b2024-11-22WarningsExact identifier
application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC9a9d42ad-79d5-4acc-b5d9-cb7468961d472024-11-22WarningsExact identifier
application number: M003
Universal 50% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC044a6287-f568-4cfa-a813-7fc0e6ffc3522024-11-22WarningsExact identifier
application number: M003
NEXXGEN 70% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLCce73ac48-c5af-4a35-950c-62ff0232aa302024-11-22WarningsExact identifier
application number: M003
Universal 70% Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLCd8b9b0e7-2cb8-4fc5-af55-790e64d6cfe82024-11-22WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78691-027-017869100270130 mL in 1 BOTTLE, SPRAY (78691-027-01) 30 ml2025-04-15NoNoCurrent