Sani-Sure AF

Product NDC
65585-360
11-digit product format
655850360
Labeler code
65585
Product ID
65585-360_215edd0e-bebd-1ffb-e063-6294a90a12a9
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Whisk Products, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-04
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
Sani-Sure AF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1038799

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65585-360-01Sani-Sure AF4 in 1 BAGSOLUTION41
65585-360-01Sani-Sure AF1000 mL in 1 BAGSOLUTION10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65585-360SANI-SURE AF (BENZALKONIUM CHLORIDE) SOLUTION [WHISK PRODUCTS, INC.]1Current NDC, 2 package rows20240906_215edd45-6266-0bfe-e063-6294a90ae9ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN215edd45-6266-0bfe-e063-6294a90ae9ea1
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD215edd45-6266-0bfe-e063-6294a90ae9ea1
1038799benzalkonium chloride 0.1 % Topical FoamSY215edd45-6266-0bfe-e063-6294a90ae9ea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65585-360-01655850360014 BAG in 1 BAG (65585-360-01) / 1000 mL in 1 BAG4 bag2024-09-04NoNoCurrent