SoftenSure Antimicrobial Foam

Product NDC
59900-216
11-digit product format
599000216
Labeler code
59900
Product ID
59900-216_29286676-a080-78e3-e063-6294a90a4ac5
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Best Sanitizers, Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-26
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 mg/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SoftenSure Antimicrobial Foam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 mg/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
29286676-a07f-78e3-e063-6294a90a4ac5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59900-216-01SoftenSure Antimicrobial Foam500 mL in 1 BOTTLELIQUID5001
59900-216-02SoftenSure Antimicrobial Foam500 mL in 1 BOTTLELIQUID5001
59900-216-02SoftenSure Antimicrobial Foam12 in 1 CASELIQUID121
59900-216-03SoftenSure Antimicrobial Foam1200 mL in 1 BOTTLELIQUID12001
59900-216-04SoftenSure Antimicrobial Foam4 in 1 CASELIQUID41
59900-216-04SoftenSure Antimicrobial Foam1200 mL in 1 BOTTLELIQUID12001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59900-216SOFTENSURE ANTIMICROBIAL FOAM (BENZALKONIUM CHLORIDE) LIQUID [BEST SANITIZERS, INC]1Current NDC, 6 package rows20241215_29286676-a07f-78e3-e063-6294a90a4ac5.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
SoftenSure Antimicrobial FoamBENZALKONIUM CHLORIDEBest Sanitizers, Inc29286676-a07f-78e3-e063-6294a90a4ac52024-12-13WarningsExact identifier
ndc (product): 59900-216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59900-216-0159900021601500 mL in 1 BOTTLE (59900-216-01) 500 ml2023-12-26NoNoCurrent
59900-216-025990002160212 BOTTLE in 1 CASE (59900-216-02) / 500 mL in 1 BOTTLE12 bottle2023-12-26NoNoCurrent
59900-216-03599000216031200 mL in 1 BOTTLE (59900-216-03) 1200 ml2023-12-26NoNoCurrent
59900-216-04599000216044 BOTTLE in 1 CASE (59900-216-04) / 1200 mL in 1 BOTTLE4 bottle2023-12-26NoNoCurrent