FDA.reportPublic FDA data

Antibacterial Bathing

Product NDC
63517-210
11-digit product format
635170210
Labeler code
63517
Product ID
63517-210_2b0d5a9c-7a58-ccfd-e063-6394a90ae938
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Cardinal Health, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-15
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Antibacterial Bathing
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

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
1038558Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
586463f3-d117-47ae-bbab-f7caff1f5fa8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63517-210-22Antibacterial Bathing1 in 1 POUCHCLOTH15
63517-210-22Antibacterial Bathing8 in 1 PACKETCLOTH85

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63517-210ANTIBACTERIAL BATHING (BENZALKONIUM CHLORIDE) CLOTH [CARDINAL HEALTH, INC.]5Current NDC, Legacy NDC, 2 package rows20250112_586463f3-d117-47ae-bbab-f7caff1f5fa8.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
Antibacterial BathingBENZALKONIUM CHLORIDECardinal Health, Inc.586463f3-d117-47ae-bbab-f7caff1f5fa82025-01-06WarningsExact identifier
ndc (product): 63517-210

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN586463f3-d117-47ae-bbab-f7caff1f5fa85
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD586463f3-d117-47ae-bbab-f7caff1f5fa85
1038558benzalkonium chloride 0.13 % Topical ClothSY586463f3-d117-47ae-bbab-f7caff1f5fa85
1038558benzalkonium chloride 0.13 % Topical SwabSY586463f3-d117-47ae-bbab-f7caff1f5fa85
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY586463f3-d117-47ae-bbab-f7caff1f5fa85
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY586463f3-d117-47ae-bbab-f7caff1f5fa85
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY586463f3-d117-47ae-bbab-f7caff1f5fa85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63517-210-22635170210228 POUCH in 1 PACKET (63517-210-22) / 1 PATCH in 1 POUCH / 13.775 mL in 1 PATCH8 pouch2019-05-150000-00-00NoNoCurrent