FDA.reportPublic FDA data

Biopure Antibacterial Hand Wipe

Product NDC
78691-017
11-digit product format
786910017
Labeler code
78691
Product ID
78691-017_3c320378-aacc-a884-e063-6394a90abe6c
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Quest USA Corp
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-15
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Biopure Antibacterial Hand Wipe
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1038558

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78691-017-00Biopure Antibacterial Hand Wipe50 in 1 CANISTERCLOTH505
78691-017-00Biopure Antibacterial Hand Wipe2.9 mL in 1 PATCHCLOTH2.95
78691-017-01Biopure Antibacterial Hand Wipe50 in 1 CANISTERCLOTH505
78691-017-01Biopure Antibacterial Hand Wipe3.4 mL in 1 PATCHCLOTH3.45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78691-017BIOPURE ANTIBACTERIAL HAND WIPE (BENZALKONIUM CHLORIDE) CLOTH [QUEST USA CORP]4Current NDC, 4 package rows20241217_17b907cf-ae7d-49bd-9624-cd708dbb011e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN17b907cf-ae7d-49bd-9624-cd708dbb011e5
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD17b907cf-ae7d-49bd-9624-cd708dbb011e5
1038558benzalkonium chloride 0.13 % Topical ClothSY17b907cf-ae7d-49bd-9624-cd708dbb011e5
1038558benzalkonium chloride 0.13 % Topical SwabSY17b907cf-ae7d-49bd-9624-cd708dbb011e5
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY17b907cf-ae7d-49bd-9624-cd708dbb011e5
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY17b907cf-ae7d-49bd-9624-cd708dbb011e5
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY17b907cf-ae7d-49bd-9624-cd708dbb011e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78691-017-007869100170050 in 1 CANISTERHistorical
78691-017-017869100170150 PATCH in 1 CANISTER (78691-017-01) / 3.4 mL in 1 PATCH50 patch2023-01-15NoNoHistorical