FDA.reportPublic FDA data

Hygiene Clean Clean Cotton Hand Sanitizer

Product NDC
80499-001
11-digit product format
804990001
Labeler code
80499
Product ID
80499-001_08c08704-4e9c-4151-e063-6394a90abe3a
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
USA Broom LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-30
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
Hygiene Clean Clean Cotton Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1049254

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80499-001-01Hygiene Clean Clean Cotton Hand Sanitizer237 mL in 1 BOTTLE, PLASTICLIQUID2374
80499-001-02Hygiene Clean Clean Cotton Hand Sanitizer24 in 1 BOXLIQUID244
80499-001-03Hygiene Clean Clean Cotton Hand Sanitizer50 mL in 1 BOTTLE, PLASTICLIQUID504
80499-001-04Hygiene Clean Clean Cotton Hand Sanitizer24 in 1 BOXLIQUID244
80499-001-04Hygiene Clean Clean Cotton Hand Sanitizer50 mL in 1 BOTTLE, PLASTICLIQUID504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80499-001HYGIENE CLEAN CLEAN COTTON HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [USA BROOM LLC]4Current NDC, Legacy NDC, 5 package rows20231030_affb0061-4347-7cd9-e053-2995a90ac114.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSNaffb0061-4347-7cd9-e053-2995a90ac1144
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCDaffb0061-4347-7cd9-e053-2995a90ac1144
1049254benzalkonium chloride 0.13 % Topical SolutionSYaffb0061-4347-7cd9-e053-2995a90ac1144

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80499-001-0180499000101237 mL in 1 BOTTLE, PLASTIC (80499-001-01) 237 ml2020-09-300000-00-00NoNoCurrent
80499-001-028049900010224 BOTTLE, PLASTIC in 1 BOX (80499-001-02) / 237 mL in 1 BOTTLE, PLASTIC (80499-001-01) 2020-09-300000-00-00NoNoCurrent
80499-001-038049900010350 mL in 1 BOTTLE, PLASTIC (80499-001-03) 50 ml2020-09-300000-00-00NoNoCurrent
80499-001-048049900010424 BOTTLE, PLASTIC in 1 BOX (80499-001-04) / 50 mL in 1 BOTTLE, PLASTIC2020-09-300000-00-00NoNoCurrent