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

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 Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1046593

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

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 bag2024-09-16NoNoHistorical
68196-667-04681960667042 BAG in 1 BOX (68196-667-04) / 1000 mL in 1 BAG2 bag2024-09-16NoNoHistorical