Home NDC 53329-177-25 Cleanse
Product NDC 53329-177
Requested package NDC 53329-177-25
11-digit product format 533290177
Labeler code 53329
Product ID 53329-177_4a8e1b1c-c742-35f9-e063-6294a90af7de
Type HUMAN OTC DRUG
Nonproprietary name Benzalkonium Chloride 0.13%
Dosage form SOLUTION
Route TOPICAL
Labeler Medline Industries, LP
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-08-19
Substance BENZALKONIUM CHLORIDE
Active strength .13 g/100mL
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 Cleanse
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZALKONIUM CHLORIDE .13 g/100mL
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 53329-177-04 Cleanse 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 13 53329-177-06 Cleanse 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 13 53329-177-08 Cleanse 221 mL in 1 BOTTLE, PLASTIC SOLUTION 221 13 53329-177-25 Cleanse 3790 mL in 1 BOTTLE, PLASTIC SOLUTION 3790 13 53329-177-74 Cleanse 1200 mL in 1 BOTTLE SOLUTION 1200 13 53329-177-84 Cleanse 1000 mL in 1 BOTTLE, PUMP SOLUTION 1000 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-177 CLEANSE (BENZALKONIUM CHLORIDE 0.13%) SOLUTION [MEDLINE INDUSTRIES, LP] 11 Current NDC, Legacy NDC, 6 package rows 20240531_3c56b4c2-42f5-66d7-e054-00144ff8d46c.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 53329-177-25 53329017725 3790 mL in 1 BOTTLE, PLASTIC (53329-177-25) 3790 ml 2016-08-19 0000-00-00 No No Current