FDA.reportPublic FDA data

I.C. Hand Sanitizer

Product NDC
59555-401
11-digit product format
595550401
Labeler code
59555
Product ID
59555-401_4615b07d-430b-4729-e063-6394a90a064b
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
R&R Lotion, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-14
Substance
BENZALKONIUM CHLORIDE
Active strength
1 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
I.C. Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1038799

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59555-401-112025-12-22C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-122025-12-22C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-132025-12-22C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-112025-01-30C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-122025-01-30C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-132025-01-30C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-112022-02-14C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-122022-02-14C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-132022-02-14C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-112022-01-28C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-122022-01-28C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-132022-01-28C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-112020-04-30C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-122020-04-30C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-132020-04-30C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-112019-11-27C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-122019-11-27C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer
59555-401-132019-11-27C16284748780-19855e2a2-3999-60a7-e053-dbdaa90a05bdI.C. Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59555-401-04I.C. Hand Sanitizer59 mL in 1 BOTTLE, SPRAYAEROSOL, FOAM596
59555-401-11I.C. Hand Sanitizer3785 mL in 1 BOTTLE, PUMPAEROSOL, FOAM37856
59555-401-12I.C. Hand Sanitizer591 mL in 1 BOTTLE, PUMPAEROSOL, FOAM5916
59555-401-13I.C. Hand Sanitizer50 mL in 1 BOTTLE, PUMPAEROSOL, FOAM506

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W7I.C. HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [R&R LOTION, INC.]1
BenzalkoniumACTIVE MOIETY7N6JUD5X6YI.C. HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [R&R LOTION, INC.]1
Cetrimonium ChlorideINACTIVE INGREDIENTUC9PE95IBPI.C. HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [R&R LOTION, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPI.C. HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [R&R LOTION, INC.]1
Dihydroxyethyl Cocamine OxideINACTIVE INGREDIENT8AR51R3BL5I.C. HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [R&R LOTION, INC.]1
Glycereth-17 CocoateINACTIVE INGREDIENT3057VPT0KCI.C. HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [R&R LOTION, INC.]1
Laurtrimonium ChlorideINACTIVE INGREDIENTA81MSI0FICI.C. HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [R&R LOTION, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RI.C. HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [R&R LOTION, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59555-401I.C. HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [R&R LOTION, INC.]3Current NDC, Legacy NDC, 4 package rows20220215_5361bb71-cc84-4a76-a0cf-2259a615baa4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN5361bb71-cc84-4a76-a0cf-2259a615baa46
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD5361bb71-cc84-4a76-a0cf-2259a615baa46
1038799benzalkonium chloride 0.1 % Topical FoamSY5361bb71-cc84-4a76-a0cf-2259a615baa46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59555-401-045955504010459 mL in 1 BOTTLE, SPRAY (59555-401-04) 59 ml2014-06-15NoNoCurrent
59555-401-11595550401113785 mL in 1 BOTTLE, PUMP (59555-401-11) 3785 ml2014-06-150000-00-00NoNoCurrent
59555-401-1259555040112591 mL in 1 BOTTLE, PUMP (59555-401-12) 591 ml2014-06-150000-00-00NoNoCurrent
59555-401-135955504011350 mL in 1 BOTTLE, PUMP (59555-401-13) 50 ml2014-06-150000-00-00NoNoCurrent