FDA.reportPublic FDA data

Foaming Antibacterial

Product NDC
68196-667
11-digit product format
681960667
Labeler code
68196
Product ID
68196-667_2c7710d9-b605-a2af-e063-6394a90a976c
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Sam's West, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-16
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 g/1000mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Foaming Antibacterial
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 g/1000mL

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
1046593Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e13036a-f2e6-2d09-e063-6394a90a3802Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-667-02Foaming Antibacterial1000 mL in 1 BAGSOLUTION10002
68196-667-02Foaming Antibacterial2 in 1 BOXSOLUTION22
68196-667-04Foaming Antibacterial2 in 1 BOXSOLUTION22
68196-667-04Foaming Antibacterial1000 mL in 1 BAGSOLUTION10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-667FOAMING ANTIBACTERIAL (BENZALKONIUM CHLORIDE) SOLUTION [SAM'S WEST, INC.]2Current NDC, 4 package rows20250126_1e13036a-f2e6-2d09-e063-6394a90a3802.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
Foaming AntibacterialBENZALKONIUM CHLORIDESam's West, Inc.1e13036a-f2e6-2d09-e063-6394a90a38022025-01-24WarningsExact identifier
ndc (product): 68196-667

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1e13036a-f2e6-2d09-e063-6394a90a38022
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1e13036a-f2e6-2d09-e063-6394a90a38022
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1e13036a-f2e6-2d09-e063-6394a90a38022
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1e13036a-f2e6-2d09-e063-6394a90a38022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68196-667-02681960667022 BAG in 1 BOX (68196-667-02) / 1000 mL in 1 BAG2 bag2024-09-16NoNoCurrent
68196-667-04681960667042 BAG in 1 BOX (68196-667-04) / 1000 mL in 1 BAG2 bag2024-09-16NoNoCurrent