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 82 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Beautifier Life Hand Sanitizer Mist OceanALCOHOLShenzhen Lantern Scicence Co.,Ltd.31628598-f7b8-111b-e063-6394a90a3de22025-03-28WarningsExact identifier
application number: M003
Beautifier Life Hand Sanitizer Mist WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.31633195-d964-278b-e063-6294a90ad42d2025-03-28WarningsExact identifier
application number: M003
Beautifier Life Hand Sanitizer Mist CucumberALCOHOLShenzhen Lantern Scicence Co.,Ltd.31642cc2-c3f6-891d-e063-6294a90a28582025-03-28WarningsExact identifier
application number: M003
MeijerBENZALKONIUM CHLORIDEMeijer1e69a1b6-1b2b-8db7-e063-6294a90a78e92025-03-28WarningsExact identifier
application number: M003
Berberex Wound GelBENZETHONIUM CHLORIDE, ALLANTOINCosco International, Inc.5dd97e65-bfb3-468e-a2b1-e56d30da99df2025-03-28WarningsExact identifier
application number: M003
ANTIBACTERIAL BANDAGESBENZALKONIUM CHLORIDEGuangdong Comfort Medical Products Co., Ltd.da241df2-6153-05e4-e053-2a95a90a09842025-03-26WarningsExact identifier
application number: M003
Caring Mill Hand Advanced SanitizerETHYL ALCOHOL 70%Veridian Healthcare312e0fde-8b5b-1296-e063-6294a90a4f262025-03-25WarningsExact identifier
application number: M003
HAND SANITIZING WIPESHAND SANITIZING WIPESIMAGINE AMAZON LLC30a373d6-59cd-fc74-e063-6394a90a9a9a2025-03-24WarningsExact identifier
application number: M003
Klean-Them Hand Sanitizing TowelsBENZALKONIUM CHLORIDERite-Kem, Inc.30dedeee-aadd-6436-e063-6394a90a0cde2025-03-21WarningsExact identifier
application number: M003
SaniiswabISOPROPYL ALCOHOLPOLLEY MED LLC303b1ad5-a104-3479-e063-6294a90abcde2025-03-20WarningsExact identifier
application number: M003
XTRA Squeeze Antibacterial Hand Juicy OrangeBENZALKONIUM CHLORIDEMY IMPORTS USA LLC304ab556-36d8-5fba-e063-6394a90a234a2025-03-19WarningsExact identifier
application number: M003
XTRA Squeeze Antibacterial Hand Juicy OrangeBENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.2f03b094-c470-d0f4-e063-6394a90a47fc2025-03-19WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.30997964-e81e-2159-e063-6294a90ad5dc2025-03-18WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.309abafa-0118-dd48-e063-6294a90a6e9f2025-03-18WarningsExact identifier
application number: M003
Smart Care Strawberry Hand Sanitizer strawberry 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3086faf2-e6e3-a7da-e063-6394a90ace542025-03-17WarningsExact identifier
application number: M003
AEROCLEANSE Instant Hand SanitizerINSTANT HAND SANITIZERAero Healthcare45aad3a4-dc7e-4b51-e054-00144ff88e882025-03-12WarningsExact identifier
application number: M003
Signature Care Instant Hand Sanitizizer WipesALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.0f6a30de-4100-4673-ab9e-256bb137919b2025-03-11WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2fa8bf7a-8efc-923d-e063-6394a90a6bbb2025-03-06WarningsExact identifier
application number: M003
Jianerkang One Fluid Ounce Hydrogen PeroxideHYDROGEN PEROXIDEJianerkang Medical Co., Ltd0cd2cefc-89db-49f9-b187-150c21e7f6712025-03-06WarningsExact identifier
application number: M003
XTRABENZALKONIUM CHLORIDEZhejiang Jifu Daily Chemical Co., Ltd.27df3fce-3958-d4ea-e063-6394a90a17852025-03-06WarningsExact 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