FDA.reportPublic FDA data

Cleanse

Product NDC
53329-177
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

Additional Listing Data#

Finished product
Yes
Brand name base
Cleanse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046593Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c56b4c2-42f5-66d7-e054-00144ff8d46cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-177-04Cleanse118 mL in 1 BOTTLE, PLASTICSOLUTION11813
53329-177-06Cleanse473 mL in 1 BOTTLE, PLASTICSOLUTION47313
53329-177-08Cleanse221 mL in 1 BOTTLE, PLASTICSOLUTION22113
53329-177-25Cleanse3790 mL in 1 BOTTLE, PLASTICSOLUTION379013
53329-177-74Cleanse1200 mL in 1 BOTTLESOLUTION120013
53329-177-84Cleanse1000 mL in 1 BOTTLE, PUMPSOLUTION100013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-177CLEANSE (BENZALKONIUM CHLORIDE 0.13%) SOLUTION [MEDLINE INDUSTRIES, LP]11Current NDC, Legacy NDC, 6 package rows20240531_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CleanseBENZALKONIUM CHLORIDE 0.13%Medline Industries, LP3c56b4c2-42f5-66d7-e054-00144ff8d46c2026-02-11WarningsExact identifier
ndc (product): 53329-177

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN3c56b4c2-42f5-66d7-e054-00144ff8d46c13
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD3c56b4c2-42f5-66d7-e054-00144ff8d46c13
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY3c56b4c2-42f5-66d7-e054-00144ff8d46c13
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY3c56b4c2-42f5-66d7-e054-00144ff8d46c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-177-0453329017704118 mL in 1 BOTTLE, PLASTIC (53329-177-04) 118 ml2016-08-190000-00-00NoNoCurrent
53329-177-0653329017706473 mL in 1 BOTTLE, PLASTIC (53329-177-06) 473 ml2016-08-190000-00-00NoNoCurrent
53329-177-0853329017708221 mL in 1 BOTTLE, PLASTIC (53329-177-08) 221 ml2016-08-190000-00-00NoNoCurrent
53329-177-25533290177253790 mL in 1 BOTTLE, PLASTIC (53329-177-25) 3790 ml2016-08-190000-00-00NoNoCurrent
53329-177-74533290177741200 mL in 1 BOTTLE (53329-177-74) 1200 ml2023-08-01NoNoCurrent
53329-177-84533290177841000 mL in 1 BOTTLE, PUMP (53329-177-84) 1000 ml2016-08-190000-00-00NoNoCurrent