ANTIBACTERIAL

Product NDC
76162-897
11-digit product format
761620897
Labeler code
76162
Product ID
76162-897_4c9c50bd-ccb6-b49e-e063-6394a90aec6d
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride soap
Dosage form
LIQUID
Route
TOPICAL
Labeler
Topco Associates LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-18
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ANTIBACTERIAL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1046593

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-897-03ANTIBACTERIAL1478 mL in 1 BOTTLE, PLASTICLIQUID14783
76162-897-96ANTIBACTERIAL221 mL in 1 BOTTLE, PLASTICLIQUID2213

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN463eafac-2367-3e5a-e063-6294a90a62933
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD463eafac-2367-3e5a-e063-6294a90a62933
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY463eafac-2367-3e5a-e063-6294a90a62933
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY463eafac-2367-3e5a-e063-6294a90a62933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-897-03761620897031478 mL in 1 BOTTLE, PLASTIC (76162-897-03) 1478 ml2025-12-18NoNoCurrent
76162-897-9676162089796221 mL in 1 BOTTLE, PLASTIC (76162-897-96) 221 ml2025-12-18NoNoCurrent