FDA.reportPublic FDA data

ANTIBACTERIAL WIPES

Product NDC
76635-009
11-digit product format
766350009
Labeler code
76635
Product ID
76635-009_d57057eb-dbf9-136d-e053-2995a90ab497
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
Hangzhou Glamcos Biotech CO.,LTD
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-08-29
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76635-009IInactivated by FDA2026-10-05
excluded packagepackage76635-00976635-009-01IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76635-009-01ANTIBACTERIAL WIPES329 g in 1 PAILCLOTH3293

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76635-009ANTIBACTERIAL WIPES (BENZALKONIUM CHLORIDE) CLOTH [HANGZHOU GLAMCOS BIOTECH CO.,LTD]3Legacy NDC, 1 package rows20231123_adf9590e-e15a-3674-e053-2995a90a8708.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2360919benzalkonium Cl 0.2 % Medicated PadPSNadf9590e-e15a-3674-e053-2995a90a87083
2360919benzalkonium chloride 2 MG/ML Medicated PadSCDadf9590e-e15a-3674-e053-2995a90a87083
2360919benzalkonium chloride 0.2 % Medicated WipeSYadf9590e-e15a-3674-e053-2995a90a87083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76635-009-0176635000901329 g in 1 PAIL (76635-009-01) 329 g2020-08-290000-00-00NoNoCurrent