RoyceDerm Antibacterial Body Wash

Product NDC
85424-016
11-digit product format
854240016
Labeler code
85424
Product ID
85424-016_4a0c66b1-5a70-b9b9-e063-6294a90a3d77
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride 0.13%
Dosage form
GEL
Route
TOPICAL
Labeler
RoyceDerm LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-26
Substance
BENZALKONIUM CHLORIDE
Active strength
.65 g/500g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RoyceDerm Antibacterial Body Wash
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.65 g/500g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1046593

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-016-01RoyceDerm Antibacterial Body Wash500 g in 1 CARTONGEL5001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN4a0c66b1-5a6f-b9b9-e063-6294a90a3d771
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD4a0c66b1-5a6f-b9b9-e063-6294a90a3d771
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY4a0c66b1-5a6f-b9b9-e063-6294a90a3d771
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY4a0c66b1-5a6f-b9b9-e063-6294a90a3d771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85424-016-0185424001601500 g in 1 CARTON (85424-016-01) 500 g2026-02-26NoNoHistorical