FDA.reportPublic FDA data

BIOPURE 20CT ANTIBACTERIAL HAND WIPES WITH ALOE AND VITAMIN E - BLUEBERRY WAFFLE

Product NDC
78691-043
11-digit product format
786910043
Labeler code
78691
Product ID
78691-043_5cac7518-2f53-c8f5-e063-6294a90a9200
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Quest USA Corp
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-30
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 20CT ANTIBACTERIAL HAND WIPES WITH ALOE AND VITAMIN E - BLUEBERRY WAFFLE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

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 76 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer BarbieALCOHOLShenzhen Lantern Scicence Co.,Ltd.371ef8bb-9e3e-e5cc-e063-6394a90a4b6e2025-06-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer SpidermanALCOHOLShenzhen Lantern Scicence Co.,Ltd.371f6cbb-0164-e82d-e063-6294a90ae2df2025-06-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer --SquishmallowsALCOHOLShenzhen Lantern Scicence Co.,Ltd.371b5429-a392-02d0-e063-6294a90a7fe82025-06-08WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer TransformerALCOHOLShenzhen Lantern Scicence Co.,Ltd.371c47f6-ba88-4a7c-e063-6294a90a16972025-06-08WarningsExact identifier
application number: M003
Singular Wipes fragrance freeISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLC6026cb8b-4556-41bd-a7b9-d9bb309005c72025-06-06WarningsExact identifier
application number: M003
Singular WipesALCOHOLSINGULAR ENTERPRISES LLC03957345-ccd0-4def-b528-7733e6a24cbb2025-06-06WarningsExact identifier
application number: M003
Travel WipesISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLC818b4280-a1cb-4c69-908f-f687f7c84ad92025-06-06WarningsExact identifier
application number: M003
Singular Wipes lavender fragranceALCOHOLSINGULAR ENTERPRISES LLC9499fde0-ec1c-4880-b83b-62bc78686d992025-06-06WarningsExact identifier
application number: M003
Travel Wipes Moisturizer and fragranceALCOHOLSINGULAR ENTERPRISES LLC46024d13-84dd-47a9-af76-d2feba62448c2025-06-06WarningsExact identifier
application number: M003
The Pharma-C Company 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLKleen Test Products Corporationa0f93dac-7baa-4f79-b6a0-3cabe52806bb2025-06-04WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Apple Pear CloveETHYL ALCOHOL 70%MY IMPORTS USA LLC36a67d51-c80f-b8a9-e063-6394a90ac7be2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer RainfallETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36a68ecb-3216-eeb2-e063-6294a90a5bba2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer RainfallETHYL ALCOHOL 70%MY IMPORTS USA LLC36a7b358-131c-88fc-e063-6394a90a007f2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Citrus GroveETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36a7bbf0-166b-54dc-e063-6294a90a1c162025-06-03WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizer Sprays (Blissful Cherry, Candy Cane Cocoa, Molten Marshmallows)ALCOHOLScent Theory Products LLC36b0eec0-33b2-2055-e063-6394a90af7302025-06-03WarningsExact identifier
application number: M003
Scent Theory Hand Sanitizer Sprays (Pink Champagne, Harvest Berry, Cozy Coconut)ALCOHOLScent Theory Products LLC36b105ef-82a5-7f95-e063-6394a90a8c1b2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Citrus GroveETHYL ALCOHOL 70%MY IMPORTS USA LLC36b4fb1c-9b19-63c3-e063-6394a90a5e352025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Spearmint EucalyptusETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b55178-6f31-85a9-e063-6394a90a56bc2025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunflower HazeETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b5ebda-1448-bc40-e063-6294a90af6d42025-06-03WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CashmereETHYL ALCOHOL 70%Zhejiang Guoyao Jingyue Aerosol Co., Ltd.36b63138-8ec9-e84a-e063-6394a90a68e32025-06-03WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78691-043-007869100430020 mL in 1 CANISTER (78691-043-00) 20 ml2026-09-30NoNoCurrent