FDA.reportPublic FDA data

ReadyBath Select

Product NDC
53329-182
Requested package NDC
53329-182-76
11-digit product format
533290182
Labeler code
53329
Product ID
53329-182_374df684-92be-c0cc-e063-6394a90a3c32
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
2027-04-30
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 Select

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
3337b028-2291-0a1d-e054-00144ff88e88Available 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
53329-182-76ReadyBath Select91 g in 1 PACKAGECLOTH916

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-182READYBATH SELECT (BENZALKONIUM CHLORIDE) CLOTH [MEDLINE INDUSTRIES, LP]5Current NDC, Legacy NDC, 1 package rows20241207_3337b028-2291-0a1d-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
ReadyBath SelectBENZALKONIUM CHLORIDEMedline Industries, LP3337b028-2291-0a1d-e054-00144ff88e882025-06-11WarningsExact identifier
ndc (package): 53329-182-76
ndc (product): 53329-182
ndc11 (package): 53329018276

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038741benzalkonium Cl 0.12 % Medicated PadPSN3337b028-2291-0a1d-e054-00144ff88e886
1038746ReadyBath 0.12 % Medicated PadPSN3337b028-2291-0a1d-e054-00144ff88e886
1038746benzalkonium chloride 1.2 MG/ML Medicated Pad [ReadyBath]SBD3337b028-2291-0a1d-e054-00144ff88e886
1038741benzalkonium chloride 1.2 MG/ML Medicated PadSCD3337b028-2291-0a1d-e054-00144ff88e886
1038741benzalkonium chloride 0.12 % Medicated WipeSY3337b028-2291-0a1d-e054-00144ff88e886
1038741benzalkonium chloride 0.12 % Topical ClothSY3337b028-2291-0a1d-e054-00144ff88e886
1038741benzalkonium chloride 0.12 % Topical SwabSY3337b028-2291-0a1d-e054-00144ff88e886
1038746ReadyBath 0.12 % Medicated PadSY3337b028-2291-0a1d-e054-00144ff88e886
1038746ReadyBath 1.2 MG/ML Medicated PadSY3337b028-2291-0a1d-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-182-765332901827691 g in 1 PACKAGE (53329-182-76) 91 g2016-05-012027-04-30NoNoCurrent