FDA.reportPublic FDA data

Antibacterial Wipes

Product NDC
76635-001
Requested package NDC
76635-001-12
11-digit product format
766350001
Labeler code
76635
Product ID
76635-001_d5702f8c-246e-92b1-e053-2995a90abce6
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
2020-05-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage76635-00176635-001-12IInactivated by FDA2026-10-12

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
76635-001-01Antibacterial Wipes432 g in 1 BAGCLOTH43211
76635-001-02Antibacterial Wipes346 g in 1 BAGCLOTH34611
76635-001-03Antibacterial Wipes173 g in 1 BAGCLOTH17311
76635-001-04Antibacterial Wipes87 g in 1 BAGCLOTH8711
76635-001-05Antibacterial Wipes47 g in 1 BAGCLOTH4711
76635-001-06Antibacterial Wipes1700 g in 1 PAILCLOTH170011
76635-001-07Antibacterial Wipes1700 g in 1 PAILCLOTH170011
76635-001-08Antibacterial Wipes4.3 g in 1 BAGCLOTH4.311
76635-001-09Antibacterial Wipes1700 g in 1 PAILCLOTH170011
76635-001-10Antibacterial Wipes303 g in 1 BAGCLOTH30311
76635-001-11Antibacterial Wipes1215 g in 1 PAILCLOTH121511
76635-001-12Antibacterial Wipes480 g in 1 PAILCLOTH48011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76635-001ANTIBACTERIAL WIPES (BENZALKONIUM CHLORIDE) CLOTH [HANGZHOU GLAMCOS BIOTECH CO.,LTD]11Legacy NDC, 12 package rows20231123_a42cf701-83c0-f562-e053-2995a90aad83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2360919benzalkonium Cl 0.2 % Medicated PadPSNa42cf701-83c0-f562-e053-2995a90aad8311
2360919benzalkonium chloride 2 MG/ML Medicated PadSCDa42cf701-83c0-f562-e053-2995a90aad8311
2360919benzalkonium chloride 0.2 % Medicated WipeSYa42cf701-83c0-f562-e053-2995a90aad8311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76635-001-1276635000112480 g in 1 PAIL (76635-001-12) 480 g2020-10-080000-00-00NoNoCurrent