FDA.reportPublic FDA data

Biopure antibacterial hand wipe

Product NDC
78691-004
Requested package NDC
78691-004-00
11-digit product format
786910004
Labeler code
78691
Product ID
78691-004_ef553044-b3fc-21e1-e053-2995a90a2245
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
QUEST USA CORP.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-09-15
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage78691-00478691-004-00IInactivated by FDA2026-09-14

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage78691-00478691-004-00IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage78691-00478691-004-00IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
78691-004-00Biopure antibacterial hand wipe
78691-004-01Biopure antibacterial hand wipe
78691-004-02Biopure antibacterial hand wipe
78691-004-03Biopure antibacterial hand wipe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78691-004-00Biopure antibacterial hand wipe1600 in 1 BAGCLOTH16007
78691-004-00Biopure antibacterial hand wipe3.44 mL in 1 PATCHCLOTH3.447
78691-004-01Biopure antibacterial hand wipe800 in 1 BAGCLOTH8007
78691-004-01Biopure antibacterial hand wipe3.25 mL in 1 PATCHCLOTH3.257
78691-004-02Biopure antibacterial hand wipe5.7 mL in 1 PATCHCLOTH5.77
78691-004-02Biopure antibacterial hand wipe50 in 1 POUCHCLOTH507
78691-004-03Biopure antibacterial hand wipe100 in 1 CANISTERCLOTH1007
78691-004-03Biopure antibacterial hand wipe5.37 mL in 1 PATCHCLOTH5.377

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78691-004BIOPURE ANTIBACTERIAL HAND WIPE (BENZALKONIUM CHLORIDE) CLOTH [QUEST USA CORP.]7Legacy NDC, 8 package rows20240214_ad2b0d05-f0e1-2b6f-e053-2a95a90ac489.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038741benzalkonium Cl 0.12 % Medicated PadPSNad2b0d05-f0e1-2b6f-e053-2a95a90ac4897
1038741benzalkonium chloride 1.2 MG/ML Medicated PadSCDad2b0d05-f0e1-2b6f-e053-2a95a90ac4897
1038741benzalkonium chloride 0.12 % Medicated WipeSYad2b0d05-f0e1-2b6f-e053-2a95a90ac4897
1038741benzalkonium chloride 0.12 % Topical ClothSYad2b0d05-f0e1-2b6f-e053-2a95a90ac4897
1038741benzalkonium chloride 0.12 % Topical SwabSYad2b0d05-f0e1-2b6f-e053-2a95a90ac4897

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78691-004-00786910004001600 PATCH in 1 BAG (78691-004-00) > 3.44 mL in 1 PATCH1600 patch2020-09-152022-12-31NoNoCurrent