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

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
RoyceDerm Antibacterial Body Wash
Listing expiration
2027-12-31

Active Ingredients#

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

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
4a0c66b1-5a6f-b9b9-e063-6294a90a3d77Available on FDA.report

DailyMed Package Descriptions#

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

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 72 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WICKED HAND SANITIZER WATERMELONALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0e9352-15c9-954a-e063-6294a90a7a672025-07-29WarningsExact identifier
application number: M003
WICKED HAND SANITIZER STRAWBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0e7e57-6472-6cca-e063-6294a90a63a62025-07-29WarningsExact identifier
application number: M003
MISTIFY HAND SANITIZER COCONUTALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0f1b10-ed25-0949-e063-6394a90a6a802025-07-29WarningsExact identifier
application number: M003
MISTIFY HAND SANITIZER MANGOALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b0fd685-c807-75e4-e063-6394a90a3d652025-07-29WarningsExact identifier
application number: M003
MISTIFY HAND SANITIZER PEACHALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b104177-be18-8b50-e063-6394a90a3b392025-07-29WarningsExact identifier
application number: M003
MISTIFY HAND SANITIZER CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3b4680c7-562f-c78b-e063-6294a90a5d1a2025-07-29WarningsExact identifier
application number: M003
Nourishing Sanitizing Hand Wipes EucalyptusALCOHOL SOLUTIONNoshinku3affe837-6789-6213-e063-6294a90a9fea2025-07-28WarningsExact identifier
application number: M003
Nourishing Sanitizing Hand Wipes LavendulaALCOHOL SOLUTIONNoshinku3b0016b4-ccad-5eb5-e063-6294a90a36ca2025-07-28WarningsExact identifier
application number: M003
Nourishing Sanitizing Hand Wipes BergamotALCOHOL SOLUTIONNoshinku3b0035e8-d95e-f5f2-e063-6394a90aca012025-07-28WarningsExact identifier
application number: M003
Kills Hand SanitizerALCOHOLDermazone LLCced12de7-32c1-4882-af22-f5373b2ceddb2025-07-25WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3aab23c1-53ad-9e60-e063-6394a90a26ec2025-07-24WarningsExact identifier
application number: M003
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3aabb047-7277-d9cb-e063-6394a90a92242025-07-24WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp3249f563-7968-e512-e063-6394a90aad522025-07-18WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Cranberry SageETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a1c90df-19ee-b249-e063-6394a90af33b2025-07-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Mango Peach SplashETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a1cd4ae-4a6e-bfcc-e063-6394a90aad032025-07-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Floral MorningETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a1d0f0b-e330-f674-e063-6394a90aec492025-07-17WarningsExact identifier
application number: M003
WISH 91% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLLJ Pharma449df7ac-97ac-41f3-a3c8-cf0d7c597e052025-07-17WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 70%ISOPROPYL ALCOHOLLJ Pharmaedea3130-a766-4166-80b6-a93525f5a7372025-07-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coconut SandalwoodETHYL ALCOHOLMY IMPORTS USA LLC3a2a1165-b710-3bf6-e063-6294a90a352d2025-07-17WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Cranberry SageETHYL ALCOHOLMY IMPORTS USA LLC3a2a36bb-c55d-67a0-e063-6294a90a1cf42025-07-17WarningsExact identifier
application number: M003

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 g2026-02-26NoNoCurrent