FDA.reportPublic FDA data

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038799Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
215edd45-6266-0bfe-e063-6294a90ae9eaAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sani-Sure AFBENZALKONIUM CHLORIDEWhisk Products, Inc.215edd45-6266-0bfe-e063-6294a90ae9ea2024-09-05WarningsExact identifier
ndc (product): 65585-360

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