FDA.reportPublic FDA data

Tork Hand Sanitizing Alcohol-Free Foam

Product NDC
49351-303
11-digit product format
493510303
Labeler code
49351
Product ID
49351-303_4a034860-fb7e-6c7f-e063-6294a90a72cc
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Essity Professional Hygiene North America LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-18
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tork Hand Sanitizing Alcohol-Free Foam
Listing expiration
2027-12-31

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
1020365Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9761e9d-21d5-4dcd-8e31-bb722c517891Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49351-303-01Tork Hand Sanitizing Alcohol-Free Foam1000 mL in 1 BOTTLELIQUID10007
49351-303-02Tork Hand Sanitizing Alcohol-Free Foam44 mL in 1 BOTTLELIQUID447

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49351-303TORK HAND SANITIZING ALCOHOL-FREE FOAM (BENZALKONIUM CHLORIDE) LIQUID [ESSITY PROFESSIONAL HYGIENE NORTH AMERICA LLC]5Current NDC, Legacy NDC, 2 package rows20241207_c9761e9d-21d5-4dcd-8e31-bb722c517891.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 Hand Sanitizing Alcohol-Free FoamBENZALKONIUM CHLORIDEEssity Professional Hygiene North America LLCc9761e9d-21d5-4dcd-8e31-bb722c5178912026-02-04Warnings, Adverse reactionsExact identifier
ndc (product): 49351-303

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSNc9761e9d-21d5-4dcd-8e31-bb722c5178917
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCDc9761e9d-21d5-4dcd-8e31-bb722c5178917
1020365benzalkonium chloride 0.13 % Topical FoamSYc9761e9d-21d5-4dcd-8e31-bb722c5178917

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49351-303-01493510303011000 mL in 1 BOTTLE (49351-303-01) 1000 ml2022-12-180000-00-00NoNoCurrent
49351-303-024935103030244 mL in 1 BOTTLE (49351-303-02) 44 ml2022-12-180000-00-00NoNoCurrent