FDA.reportPublic FDA data

U HAND SANITIZER CLASSIC

Product NDC
72119-004
11-digit product format
721190004
Labeler code
72119
Product ID
72119-004_289f021f-0aa6-af6b-e063-6394a90a15d2
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
BLUE SEA AEROSOL & DAILY CARE CO., LTD
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-19
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
U HAND SANITIZER CLASSIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1049254

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72119-004-012024-12-07C16284748780-1d6a99b39-752c-a426-e053-dadaa90af4c272119-004
72119-004-022024-12-07C16284748780-1d6a99b39-752c-a426-e053-dadaa90af4c272119-004
72119-004-032024-12-07C16284748780-1d6a99b39-752c-a426-e053-dadaa90af4c272119-004
72119-004-012022-01-28C16284748780-1d6a99b39-752c-a426-e053-dadaa90af4c272119-004
72119-004-022022-01-28C16284748780-1d6a99b39-752c-a426-e053-dadaa90af4c272119-004
72119-004-032022-01-28C16284748780-1d6a99b39-752c-a426-e053-dadaa90af4c272119-004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72119-004-01U HAND SANITIZER CLASSIC100 mL in 1 BOTTLESOLUTION1002
72119-004-02U HAND SANITIZER CLASSIC200 mL in 1 BOTTLESOLUTION2002
72119-004-03U HAND SANITIZER CLASSIC473 mL in 1 BOTTLESOLUTION4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72119-004U HAND SANITIZER CLASSIC (BENZALKONIUM CHLORIDE) SOLUTION [BLUE SEA AEROSOL & DAILY CARE CO., LTD]2Current NDC, Legacy NDC, 3 package rows20241208_fbc27a24-0e81-4907-b24f-881c4fe0ec44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSNfbc27a24-0e81-4907-b24f-881c4fe0ec442
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCDfbc27a24-0e81-4907-b24f-881c4fe0ec442
1049254benzalkonium chloride 0.13 % Topical SolutionSYfbc27a24-0e81-4907-b24f-881c4fe0ec442

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72119-004-0172119000401100 mL in 1 BOTTLE (72119-004-01) 100 ml2020-06-190000-00-00NoNoCurrent
72119-004-0272119000402200 mL in 1 BOTTLE (72119-004-02) 200 ml2020-06-190000-00-00NoNoCurrent
72119-004-0372119000403473 mL in 1 BOTTLE (72119-004-03) 473 ml2020-06-190000-00-00NoNoCurrent