FDA.reportPublic FDA data

ReadyBath Luxe

Product NDC
53329-181
11-digit product format
533290181
Labeler code
53329
Product ID
53329-181_374df66d-eb9a-c4a7-e063-6394a90a3cc6
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
Medline Industries, LP
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-05-01
Marketing end
2027-05-31
Substance
BENZALKONIUM CHLORIDE
Active strength
.12 g/100g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ReadyBath Luxe

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.12 g/100g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038741Internal RxNorm lookup
1038746Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
33376694-fccd-6ed5-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-181-76ReadyBath Luxe129 g in 1 PACKAGECLOTH1296

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-181READYBATH LUXE (BENZALKONIUM CHLORIDE) CLOTH [MEDLINE INDUSTRIES, LP]5Current NDC, Legacy NDC, 1 package rows20241206_33376694-fccd-6ed5-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
ReadyBath LuxeBENZALKONIUM CHLORIDEMedline Industries, LP33376694-fccd-6ed5-e054-00144ff8d46c2025-06-11WarningsExact identifier
ndc (product): 53329-181

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038741benzalkonium Cl 0.12 % Medicated PadPSN33376694-fccd-6ed5-e054-00144ff8d46c6
1038746ReadyBath 0.12 % Medicated PadPSN33376694-fccd-6ed5-e054-00144ff8d46c6
1038746benzalkonium chloride 1.2 MG/ML Medicated Pad [ReadyBath]SBD33376694-fccd-6ed5-e054-00144ff8d46c6
1038741benzalkonium chloride 1.2 MG/ML Medicated PadSCD33376694-fccd-6ed5-e054-00144ff8d46c6
1038741benzalkonium chloride 0.12 % Medicated WipeSY33376694-fccd-6ed5-e054-00144ff8d46c6
1038741benzalkonium chloride 0.12 % Topical ClothSY33376694-fccd-6ed5-e054-00144ff8d46c6
1038741benzalkonium chloride 0.12 % Topical SwabSY33376694-fccd-6ed5-e054-00144ff8d46c6
1038746ReadyBath 0.12 % Medicated PadSY33376694-fccd-6ed5-e054-00144ff8d46c6
1038746ReadyBath 1.2 MG/ML Medicated PadSY33376694-fccd-6ed5-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-181-7653329018176129 g in 1 PACKAGE (53329-181-76) 129 g2016-05-012027-05-31NoNoCurrent