Home NDC 65321-031-02 Antibacterial
Product NDC 65321-031
Requested package NDC 65321-031-02
11-digit product format 653210031
Labeler code 65321
Product ID 65321-031_dab4b4c1-bc8d-4552-8d19-f683087d00ab
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride
Dosage form SOAP
Route TOPICAL
Labeler Rubbermaid Commercial Products LLC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-07-24
Substance BENZALKONIUM CHLORIDE
Active strength 13 mg/10mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Antibacterial
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE 13 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1046593 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65321-031-01 Antibacterial 800 mL in 1 BOTTLE, PUMP SOAP 800 5 65321-031-02 Antibacterial 1600 mL in 1 BOTTLE, PUMP SOAP 1600 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65321-031 ANTIBACTERIAL (BENZALKONIUM CHLORIDE) SOAP [RUBBERMAID COMMERCIAL PRODUCTS LLC] 5 Current NDC, Legacy NDC, 2 package rows 20241013_6023285c-6b02-410e-9492-df0543279f25.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65321-031-02 65321003102 1600 mL in 1 BOTTLE, PUMP (65321-031-02) 1600 ml 2017-07-24 0000-00-00 No No Current