FDA.reportPublic FDA data

Antibacterial Wipes

Product NDC
52489-002
Requested package NDC
52489-002-08
11-digit product format
524890002
Labeler code
52489
Product ID
52489-002_aed5a7ef-5cf4-6738-e053-2a95a90aa7f7
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
Imperial Palace Commodity (shenzhen) Co., Ltd
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-05-27
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage52489-00252489-002-08IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
52489-002-01a683f890-e038-65d8-e053-2995a90a4628
52489-002-02a683f890-e038-65d8-e053-2995a90a4628
52489-002-03a683f890-e038-65d8-e053-2995a90a4628
52489-002-04a683f890-e038-65d8-e053-2995a90a4628
52489-002-05a683f890-e038-65d8-e053-2995a90a4628
52489-002-06a683f890-e038-65d8-e053-2995a90a4628
52489-002-07a683f890-e038-65d8-e053-2995a90a4628
52489-002-08a683f890-e038-65d8-e053-2995a90a4628
52489-002-09a683f890-e038-65d8-e053-2995a90a4628

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52489-002-01Antibacterial Wipes360 mL in 1 PACKAGECLOTH3604
52489-002-02Antibacterial Wipes370 mL in 1 PAILCLOTH3704
52489-002-03Antibacterial Wipes940 mL in 1 PAILCLOTH9404
52489-002-04Antibacterial Wipes3000 mL in 1 PAILCLOTH30004
52489-002-05Antibacterial Wipes3.3 mL in 1 PACKAGECLOTH3.34
52489-002-06Antibacterial Wipes4.6 mL in 1 PACKAGECLOTH4.64
52489-002-07Antibacterial Wipes230 mL in 1 PACKAGECLOTH2304
52489-002-08Antibacterial Wipes280 mL in 1 PACKAGECLOTH2804
52489-002-09Antibacterial Wipes3560 mL in 1 PACKAGECLOTH35604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52489-002ANTIBACTERIAL WIPES (BENZALKONIUM CHLORIDE) CLOTH [IMPERIAL PALACE COMMODITY (SHENZHEN) CO., LTD]4Legacy NDC, 9 package rows20231121_a683f890-e038-65d8-e053-2995a90a4628.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNa683f890-e038-65d8-e053-2995a90a46284
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDa683f890-e038-65d8-e053-2995a90a46284
1038558benzalkonium chloride 0.13 % Topical ClothSYa683f890-e038-65d8-e053-2995a90a46284
1038558benzalkonium chloride 0.13 % Topical SwabSYa683f890-e038-65d8-e053-2995a90a46284
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYa683f890-e038-65d8-e053-2995a90a46284
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYa683f890-e038-65d8-e053-2995a90a46284
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYa683f890-e038-65d8-e053-2995a90a46284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52489-002-0852489000208280 mL in 1 PACKAGE (52489-002-08) 280 ml2020-07-220000-00-00NoNoCurrent