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
Ingredient	Strength
BENZALKONIUM CHLORIDE	.65 g/500g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1046593	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
4a0c66b1-5a6f-b9b9-e063-6294a90a3d77	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85424-016-01	RoyceDerm Antibacterial Body Wash	500 g in 1 CARTON	GEL	500		1

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 56 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAND SANITIZING LAVENDER	ALCOHOL	DR. BRONNER'S MAGIC SOAPS	8383605a-0bac-428c-b1cb-2f95ce9bd35e	2025-10-28	Warnings	Exact identifier application number: M003
ORGANIC HAND SANITIZER PEPPERMINT	ALCOHOL	DR. BRONNER'S MAGIC SOAPS	cad3a81e-88cb-4f44-a351-b086fd983795	2025-10-28	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Lavender Drift	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421cfe98-7a20-c37c-e063-6294a90ad4b5	2025-10-27	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coastal Coconut	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421ce33e-4639-e881-e063-6394a90a57ef	2025-10-27	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Watermelon Aloe	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421d994c-bf62-2f40-e063-6294a90a6488	2025-10-27	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Peach Nectar	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421d7326-d2fd-a845-e063-6394a90a39aa	2025-10-27	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sea Breeze	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421d7bd9-c892-ec97-e063-6394a90a4b28	2025-10-27	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCake	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421d7326-d300-a845-e063-6394a90a39aa	2025-10-27	Warnings	Exact identifier application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla Cloud	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	421d8811-7fb2-aef6-e063-6394a90a1cf8	2025-10-27	Warnings	Exact identifier application number: M003
American Red Cross 70% Isopropyl Alcohol	ISOPROPYL ALCOHOL(70%CONC.)	MY IMPORTS USA LLC	421d7bd9-c893-ec97-e063-6394a90a4b28	2025-10-27	Warnings	Exact identifier application number: M003
American Red Cross Antiseptic	BENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)	MY IMPORTS USA LLC	421dc192-97ed-0675-e063-6394a90aa156	2025-10-27	Warnings	Exact identifier application number: M003
American Red Cross First Aid	BENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)	MY IMPORTS USA LLC	421f3150-2027-c6aa-e063-6294a90ab6aa	2025-10-27	Warnings	Exact identifier application number: M003
American Red Cross First Aid	BENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	421b402e-233d-cebf-e063-6394a90aa421	2025-10-27	Warnings	Exact identifier application number: M003
Germ Attack Hand Sanitizer	ALCOHOL	Natural Essentials, Inc.	637dcb5f-8870-4613-a227-9fd612617061	2025-10-27	Warnings	Exact identifier application number: M003
SOURPATCH KIDS HAND SANITIZER SET WATERMELON	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	42143916-8d2e-dbbe-e063-6294a90a29c4	2025-10-26	Warnings	Exact identifier application number: M003
JOLLY RANCHER HAND SANITIZER SET CHERRY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	42147184-18e6-f932-e063-6294a90a807e	2025-10-26	Warnings	Exact identifier application number: M003
JOLLY RANCHER HAND SANITIZER CHERRY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	4214ba08-8d00-8de9-e063-6394a90a4c90	2025-10-26	Warnings	Exact identifier application number: M003
Sour Patch Kids Hand Sanitizer Watermelon	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	4214f0de-6b1d-dae7-e063-6294a90ade42	2025-10-26	Warnings	Exact identifier application number: M003
SOURPATCH KIDS HAND SANITIZER STRAWBERRY	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	4215130c-a298-02c7-e063-6394a90a74ff	2025-10-26	Warnings	Exact identifier application number: M003
SMARTIES ORANGE HAND SANTIZER SET ORANGE CREAMSICLE	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	421b1732-acdd-a6cc-e063-6394a90a5fb4	2025-10-26	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046593	benzalkonium chloride 0.13 % Medicated Liquid Soap	PSN	4a0c66b1-5a6f-b9b9-e063-6294a90a3d77	1
1046593	benzalkonium chloride 1.3 MG/ML Medicated Liquid Soap	SCD	4a0c66b1-5a6f-b9b9-e063-6294a90a3d77	1
1046593	benzalkonium chloride 0.13 % Medicated Liquid Soap	SY	4a0c66b1-5a6f-b9b9-e063-6294a90a3d77	1
1046593	benzalkonium chloride 1.33 MG/ML Medicated Liquid Soap	SY	4a0c66b1-5a6f-b9b9-e063-6294a90a3d77	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85424-016-01	85424001601	500 g in 1 CARTON (85424-016-01)	500 g	2026-02-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Initial Drug Listing - RoyceDerm Antibacterial Body Wash- 85424-016-01--61	RoyceDerm LLC	2026-02-04	HUMAN OTC DRUG LABEL	1