FDA.reportPublic FDA data

Soft Care Instant Hand Sanitizer AF

Product NDC
64536-3628
11-digit product format
645363628
Labeler code
64536
Product ID
64536-3628_29691542-b27f-c4c3-e063-6394a90a6960
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Diversey, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-04-14
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
Soft Care Instant Hand Sanitizer AF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL

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
1049254Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
16846c69-b7e6-4ebe-b142-f1bf9b62c328Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64536-3628-3Soft Care Instant Hand Sanitizer AF1300 mL in 1 BOTTLE, PUMPSOLUTION13003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64536-3628SOFT CARE INSTANT HAND SANITIZER AF (BENZALKONIUM CHLORIDE) SOLUTION [DIVERSEY, INC.]3Current NDC, Legacy NDC, 1 package rows20241218_16846c69-b7e6-4ebe-b142-f1bf9b62c328.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
Soft Care Instant Hand Sanitizer AFBENZALKONIUM CHLORIDEDiversey, Inc.16846c69-b7e6-4ebe-b142-f1bf9b62c3282024-12-16WarningsExact identifier
ndc (product): 64536-3628

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN16846c69-b7e6-4ebe-b142-f1bf9b62c3283
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD16846c69-b7e6-4ebe-b142-f1bf9b62c3283
1049254benzalkonium chloride 0.13 % Topical SolutionSY16846c69-b7e6-4ebe-b142-f1bf9b62c3283

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64536-3628-3645363628031300 mL in 1 BOTTLE, PUMP (64536-3628-3) 1300 ml2017-04-140000-00-00NoNoCurrent