FDA.reportPublic FDA data

Biopure

Product NDC
78691-028
Requested package NDC
78691-028-01
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
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
3249f563-7968-e512-e063-6394a90aad52Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78691-028-01Biopure30 mL in 1 BOTTLE, SPRAYLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78691-028BIOPURE (HAND SANITIZER SPRAY) LIQUID [QUEST USA CORP]1Current NDC, 1 package rows20250416_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 70 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non-proprietary nameALCOHOL PREP PADGuangzhou Four E's Scientific Co., Ltd.edb4a43a-5b55-3404-e053-2a95a90ada272025-08-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk - SOURBETALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c9fe5a6-a729-4710-e063-6294a90a0da12025-08-18WarningsExact identifier
application number: M003
Premium Hand Sanitizer with AloeETHANOLMCKESSON MEDICAL-SURGICAL INC.13d42582-df02-41d5-bada-1d67c61310152025-08-18WarningsExact identifier
application number: M003
MedPride Povidone Iodine Scrub Solution Skin CleanserPOVIDONE-IODINEShield Line LLC88dfef39-c6c2-44fc-e053-2995a90a805a2025-08-18WarningsExact identifier
application number: M003
MedPride Prep Solution Topical Antiseptic MicrobicidePOVIDONE-IODINEShield Line LLC88cb1b8d-3dae-be00-e053-2995a90a0d112025-08-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk - Romance GourmondALCOHOLShenzhen Lantern Scicence Co.,Ltd.3caf5726-8d4c-9d36-e063-6294a90a3cf12025-08-18WarningsExact identifier
application number: M003
Hand Sanitizer plus Serum EdenALCOHOLMoam LLC93c9f1ad-e08a-4859-bf24-db37e6b1d3082025-08-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer OceanALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c9c71e5-fe7a-d342-e063-6294a90a774a2025-08-17WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Calming LavenderALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c76e629-96a0-7031-e063-6294a90a05ae2025-08-16WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Whispering WoodsALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.394e4b3a-5832-9f8d-e063-6294a90ac4492025-08-15WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Botanic BlushALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c62434b-c2a9-bd39-e063-6294a90af8b32025-08-15WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Golden GroveALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c62805a-7834-8a27-e063-6394a90a67fe2025-08-15WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Citrus SuedeALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c62ecc5-4252-a002-e063-6394a90ace3e2025-08-15WarningsExact identifier
application number: M003
AmeriDerm Antibacterial WashPARACHLOROMETAXYLENOLSHIELD LINE LLC6e652a7d-76bb-bb2d-e053-2a91aa0aac502025-08-15WarningsExact identifier
application number: M003
AMERIWASHPARACHLOROMETAXYLENOLSHIELD LINE LLC6d5ed0f9-fb48-7855-e053-2991aa0a18a82025-08-15WarningsExact identifier
application number: M003
365 Whole Foods Market Refreshing Hand Sanitizer Bergamot RainETHYL ALCOHOLWhole Foods Market, Inc.3c6b1a51-4097-1aad-e063-6294a90aef6f2025-08-15WarningsExact identifier
application number: M003
MedPride Bath WipesBENZALKONIUM CHLORIDEShield Line LLCecf7e545-21ca-bbe0-e053-2995a90a9a552025-08-15WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Midnight MuskALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c5f46b4-f202-2a44-e063-6294a90ac1062025-08-14WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Meadow MirageALCOHOLLANTERN HEALTH & BEAUTY SDN. BHD.3c5f8420-9673-6f77-e063-6294a90a81e42025-08-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Coconut BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.3c3af609-d342-449a-e063-6294a90a0a192025-08-13WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78691-028-017869100280130 mL in 1 BOTTLE, SPRAY (78691-028-01) 30 ml2025-04-15NoNoCurrent