FDA.reportPublic FDA data

JULEP antibacterial sanitizing wipe

Product NDC
76635-121
11-digit product format
766350121
Labeler code
76635
Product ID
76635-121_d57046f8-9dfd-71c5-e053-2995a90a144d
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
2020-09-23
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 productproduct76635-121IInactivated by FDA2026-10-05
excluded packagepackage76635-12176635-121-01IInactivated 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
76635-121-01JULEP antibacterial sanitizing wipe3.24 g in 1 BAGCLOTH3.243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76635-121JULEP ANTIBACTERIAL SANITIZING WIPE (BENZALKONIUM CHLORIDE) CLOTH [HANGZHOU GLAMCOS BIOTECH CO.,LTD]3Legacy NDC, 1 package rows20231123_afeedee8-6233-60fb-e053-2a95a90a6f60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2360919benzalkonium Cl 0.2 % Medicated PadPSNafeedee8-6233-60fb-e053-2a95a90a6f603
2360919benzalkonium chloride 2 MG/ML Medicated PadSCDafeedee8-6233-60fb-e053-2a95a90a6f603
2360919benzalkonium chloride 0.2 % Medicated WipeSYafeedee8-6233-60fb-e053-2a95a90a6f603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76635-121-01766350121013.24 g in 1 BAG (76635-121-01) 3.24 g2020-09-230000-00-00NoNoCurrent