FDA.reportPublic FDA data

Tork Foam Antibacterial

Product NDC
49351-104
Requested package NDC
49351-104-01
11-digit product format
493510104
Labeler code
49351
Product ID
49351-104_177d70c8-9d55-d9c6-e063-6294a90a7fc8
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Essity Professional Hygiene North America LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-03-15
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
45416b88-3703-4934-9439-9f2323342744Available 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
49351-104-01Tork Foam Antibacterial1000 mL in 1 BOTTLESOAP10007
49351-104-02Tork Foam Antibacterial50 mL in 1 BOTTLESOAP507
49351-104-02Tork Foam Antibacterial24 in 1 BOXSOAP247

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49351-104TORK FOAM ANTIBACTERIAL (BENZALKONIUM CHLORIDE) SOAP [ESSITY PROFESSIONAL HYGIENE NORTH AMERICA LLC]7Current NDC, Legacy NDC, 3 package rows20240504_45416b88-3703-4934-9439-9f2323342744.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
Tork Foam AntibacterialBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLC45416b88-3703-4934-9439-9f23233427442024-05-02WarningsExact identifier
ndc (package): 49351-104-01
ndc (product): 49351-104
ndc11 (package): 49351010401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN45416b88-3703-4934-9439-9f23233427447
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD45416b88-3703-4934-9439-9f23233427447
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY45416b88-3703-4934-9439-9f23233427447
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY45416b88-3703-4934-9439-9f23233427447

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49351-104-01493510104011000 mL in 1 BOTTLE (49351-104-01) 1000 ml2017-03-150000-00-00NoNoCurrent