FDA.reportPublic FDA data

Zoono Hand Sanitizer

Product NDC
69221-203
11-digit product format
692210203
Labeler code
69221
Product ID
69221-203_3d736e77-9543-2660-e063-6394a90a4609
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Zoono Holdings USA
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-20
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
Zoono Hand Sanitizer
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
69221-203-112025-08-26C16284748780-11030e364-fee1-111a-e063-dadaa90a10e2Zoono Hand Sanitizer
69221-203-132025-08-26C16284748780-11030e364-fee1-111a-e063-dadaa90a10e2Zoono Hand Sanitizer
69221-203-142025-08-26C16284748780-11030e364-fee1-111a-e063-dadaa90a10e2Zoono Hand Sanitizer
69221-203-152025-08-26C16284748780-11030e364-fee1-111a-e063-dadaa90a10e2Zoono Hand Sanitizer
69221-203-162025-08-26C16284748780-11030e364-fee1-111a-e063-dadaa90a10e2Zoono Hand Sanitizer
69221-203-112025-07-29C16284748780-11030e364-fee1-111a-e063-dadaa90a10e2Zoono Hand Sanitizer
69221-203-132025-07-29C16284748780-11030e364-fee1-111a-e063-dadaa90a10e2Zoono Hand Sanitizer
69221-203-142025-07-29C16284748780-11030e364-fee1-111a-e063-dadaa90a10e2Zoono Hand Sanitizer
69221-203-152025-07-29C16284748780-11030e364-fee1-111a-e063-dadaa90a10e2Zoono Hand Sanitizer
69221-203-162025-07-29C16284748780-11030e364-fee1-111a-e063-dadaa90a10e2Zoono Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69221-203-11Zoono Hand Sanitizer50 mL in 1 BOTTLESOLUTION509
69221-203-13Zoono Hand Sanitizer150 mL in 1 BOTTLESOLUTION1509
69221-203-14Zoono Hand Sanitizer500 mL in 1 BOTTLESOLUTION5009
69221-203-15Zoono Hand Sanitizer1000 mL in 1 BOTTLESOLUTION10009
69221-203-16Zoono Hand Sanitizer3785 mL in 1 BOTTLESOLUTION37859

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69221-203ZOONO HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [ZOONO HOLDINGS USA]8Current NDC, Legacy NDC, 5 package rows20240630_b48c9a16-5027-1fdb-e053-2a95a90a5489.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSNb48c9a16-5027-1fdb-e053-2a95a90a54899
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCDb48c9a16-5027-1fdb-e053-2a95a90a54899
1049254benzalkonium chloride 0.13 % Topical SolutionSYb48c9a16-5027-1fdb-e053-2a95a90a54899

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69221-203-116922102031150 mL in 1 BOTTLE (69221-203-11) 50 ml2020-11-200000-00-00NoNoCurrent
69221-203-1369221020313150 mL in 1 BOTTLE (69221-203-13) 150 ml2020-11-200000-00-00NoNoCurrent
69221-203-1469221020314500 mL in 1 BOTTLE (69221-203-14) 500 ml2020-11-200000-00-00NoNoCurrent
69221-203-15692210203151000 mL in 1 BOTTLE (69221-203-15) 1000 ml2020-11-200000-00-00NoNoCurrent
69221-203-16692210203163785 mL in 1 BOTTLE (69221-203-16) 3785 ml2020-11-200000-00-00NoNoCurrent