FDA.reportPublic FDA data

Biopure Antibacterial Hand Wipe Juicy Watermelon

Product NDC
78691-034
11-digit product format
786910034
Labeler code
78691
Product ID
78691-034_47d53645-4ba9-0cdc-e063-6294a90a3892
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
2026-01-09
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 Antibacterial Hand Wipe Juicy Watermelon
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038558Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47d53645-4ba8-0cdc-e063-6294a90a3892Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78691-034-00Biopure Antibacterial Hand Wipe Juicy Watermelon50 mL in 1 CANISTERCLOTH501

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 85 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer 1.8 oz Lemon IceETHYL ALCOHOLNingbo Rejoice Internationala266624f-2175-2fd4-e053-2995a90a33052025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 1.8 oz Watermelon Scented 1.8 oz.ETHYL ALCOHOLNingbo Rejoice Internationala2677a83-8f9a-7470-e053-2a95a90aa2892025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Vitamin E and Aloe Vera 2 oz. 2 pkETHYL ALCOHOLNingbo Rejoice Internationala2695f96-ef8c-bba6-e053-2a95a90a243e2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Original 1.8 ozETHYL ALCOHOLNingbo Rejoice Internationala26a866a-bb5f-4b5f-e053-2995a90a97452025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin E 2 oz. 2 pkETHYL ALCOHOLNingbo Rejoice Internationala269e72d-c74b-71ed-e053-2995a90ac1472025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala269a222-95cb-098c-e053-2995a90a21e72025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala346ebd2-fc31-b574-e053-2995a90a0d3a2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala7364361-f8ad-fc71-e053-2995a90a68a12025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Antibacterial Vitamin EETHYL ALCOHOLNingbo Rejoice Internationala73698ca-2097-3f7d-e053-2a95a90a638a2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2pk Lemon 2ozALCOHOLNingbo Rejoice Internationalb08ea7ef-a595-6bef-e053-2a95a90a68fb2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Original 8ozALCOHOLNingbo Rejoice Internationalb08ec92b-e63e-2dab-e053-2995a90a09482025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer with Clip 1.8ozALCOHOLNingbo Rejoice Internationalb08f2909-467d-719d-e053-2995a90a11a12025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2pk Aloe 2ozALCOHOLNingbo Rejoice Internationalb08f2993-f166-1a0e-e053-2a95a90a93792025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Aloe 2ozALCOHOLNingbo Rejoice Internationalb08f3bf1-f55f-5c68-e053-2a95a90ac3ac2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Lavender 2ozALCOHOLNingbo Rejoice Internationalb08f6f48-796b-3b40-e053-2a95a90a75f62025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2pk Lavender 2ozALCOHOLNingbo Rejoice Internationalb08f62b0-98dd-5aac-e053-2a95a90a6d8a2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer PouchALCOHOLNingbo Rejoice Internationalb08f8faa-d9d6-5b8d-e053-2a95a90a407c2025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 24ct PouchALCOHOLNingbo Rejoice Internationalb08fb47c-7241-45d3-e053-2a95a90a8a942025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer 2ozALCOHOLNingbo Rejoice Internationalb08fd11a-48e2-67b6-e053-2995a90ac3992025-02-13WarningsExact identifier
application number: M003
Hand Sanitizer Aloe 8ozALCOHOLNingbo Rejoice Internationalb1914c86-4489-fbb8-e053-2995a90a5cd62025-02-13WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN47d53645-4ba8-0cdc-e063-6294a90a38921
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD47d53645-4ba8-0cdc-e063-6294a90a38921
1038558benzalkonium chloride 0.13 % Topical ClothSY47d53645-4ba8-0cdc-e063-6294a90a38921
1038558benzalkonium chloride 0.13 % Topical SwabSY47d53645-4ba8-0cdc-e063-6294a90a38921
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY47d53645-4ba8-0cdc-e063-6294a90a38921
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY47d53645-4ba8-0cdc-e063-6294a90a38921
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY47d53645-4ba8-0cdc-e063-6294a90a38921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78691-034-007869100340050 mL in 1 CANISTER (78691-034-00) 50 ml2026-01-09NoNoCurrent