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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage78691-01778691-017-00DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 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
17b907cf-ae7d-49bd-9624-cd708dbb011eAvailable on FDA.report

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biopure Antibacterial Hand WipeBENZALKONIUM CHLORIDEQuest USA Corp17b907cf-ae7d-49bd-9624-cd708dbb011e2025-08-12WarningsExact identifier
ndc (product): 78691-017

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 patch2023-01-15NoNoCurrent