FDA.reportPublic FDA data

Cleanse

Product NDC
53329-184
11-digit product format
533290184
Labeler code
53329
Product ID
53329-184_4a8e1ef2-4cd2-a9a9-e063-6394a90a3990
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Medline Industries, LP
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-09-26
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
428644dd-b2e5-1675-e054-00144ff88e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-184-08Cleanse221 mL in 1 BOTTLESOLUTION22111
53329-184-74Cleanse1200 mL in 1 BOTTLESOLUTION120011
53329-184-84Cleanse1000 mL in 1 BOTTLE, PUMPSOLUTION100011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-184CLEANSE (BENZALKONIUM CHLORIDE) SOLUTION [MEDLINE INDUSTRIES, LP]9Current NDC, Legacy NDC, 3 package rows20240531_428644dd-b2e5-1675-e054-00144ff88e88.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 CHLORIDEMedline Industries, LP428644dd-b2e5-1675-e054-00144ff88e882026-02-11WarningsExact identifier
ndc (product): 53329-184

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN428644dd-b2e5-1675-e054-00144ff88e8811
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD428644dd-b2e5-1675-e054-00144ff88e8811
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY428644dd-b2e5-1675-e054-00144ff88e8811
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY428644dd-b2e5-1675-e054-00144ff88e8811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-184-0853329018408221 mL in 1 BOTTLE (53329-184-08) 221 ml2021-01-010000-00-00NoNoCurrent
53329-184-74533290184741200 mL in 1 BOTTLE (53329-184-74) 1200 ml2023-08-01NoNoCurrent
53329-184-84533290184841000 mL in 1 BOTTLE, PUMP (53329-184-84) 1000 ml2016-09-260000-00-00NoNoCurrent