FDA.reportPublic FDA data

RoyceDerm Sulfur Soap.

Product NDC
85424-003
11-digit product format
854240003
Labeler code
85424
Product ID
85424-003_3a323a77-eff5-973f-e063-6394a90a02a0
Type
HUMAN OTC DRUG
Nonproprietary name
Sulfur
Dosage form
SOAP
Route
TOPICAL
Labeler
RoyceDerm LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-01
Substance
SULFUR
Active strength
23.2 g/232g
NDC exclude flag
No
Listing certified through
2026-12-31
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 Sulfur Soap.
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR23.2 g/232g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
70FD1KFU70Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1053330Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a323a77-eff4-973f-e063-6394a90a02a0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-003-01RoyceDerm Sulfur Soap.232 g in 1 CARTONSOAP2321

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 21 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne CleanserSALICYLIC ACIDCurology44730f63-1f22-27a5-e063-6294a90a63c22025-11-25WarningsExact identifier
application number: M006
Ayadara Cystic Acne Spot TreatmentSULFURLeiluna LLC3cc17e7a-34d4-4789-a387-40e4d781091b2025-11-25WarningsExact identifier
application number: M006
Shaant Pore Purifying Face ScrubSALICYLIC ACIDCodex Labs Corporationd806e749-ea2c-4db4-af65-a1f8afce1b0e2025-11-21WarningsExact identifier
application number: M006
Shaant Spot Hero Drying Acne TreatmentSULFURCodex Labs Corporation24fa844b-e4ce-46de-a2d6-e9e863888a552025-11-21WarningsExact identifier
application number: M006
Shaant Hydrating Body ScrubSALICYLIC ACIDCodex Labs Corporation64a176a1-7dc4-44f8-8b3d-4349460a17b02025-11-21WarningsExact identifier
application number: M006
CAVOREAL Plus Salicylic Acid Anti Acne with BHA HASALICYLIC ACIDGuangzhou Meijiao Medical Biotechnology Co., Ltd.4401fff2-725f-8ff0-e063-6294a90ae9ba2025-11-20WarningsExact identifier
application number: M006
CAVOREAL Plus Salicylic Acid Anti Acne with BHA HASALICYLIC ACIDGuangzhou Meijiao Medical Biotechnology Co., Ltd.440a3a73-7136-f8b2-e063-6394a90a744d2025-11-20WarningsExact identifier
application number: M006
Acne Defense Spot Treatment Merle NormanSALICYLIC ACIDMerle Norman Cosmetics, Incc6296d3a-fabe-4a8f-91e8-cac2ae6ff9262025-11-18WarningsExact identifier
application number: M006
Perricone MD Acne Relief Calming and Soothing Clay MaskSALICYLIC ACIDTHG Beauty USA LLC23a3d093-e89b-ddaf-e063-6394a90aaa6a2025-11-14WarningsExact identifier
application number: M006
Daily MedsSALICYLIC ACIDBioelements, Inc.3ffb6cd0-c529-4420-8da8-de52838d8a642025-11-14WarningsExact identifier
application number: M006
Naturium Encapsulated Salicylic Acid Moisturizer 0.75%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a4a0de1-6feb-bf9a-e063-6394a90a32d92025-11-14WarningsExact identifier
application number: M006
Naturium Salicylic Acid Body 2%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a5b80fb-caec-eb56-e063-6294a90a238b2025-11-14WarningsExact identifier
application number: M006
Naturium Salicylic Acid Serum 2%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a28640e-37f8-9a74-e063-6294a90a15b72025-11-14WarningsExact identifier
application number: M006
Naturium Sulfur Spot Treatment 8%SULFURe.l.f. Cosmetics, Inc0a4a9aed-5eeb-f648-e063-6394a90a1d762025-11-14WarningsExact identifier
application number: M006
Acne Spot TreatmentSALICYLIC ACID ACNE TREATMENTCosMedical Technologies23bd8842-5237-4131-e054-00144ff8d46c2025-11-13WarningsExact identifier
application number: M006
Overnight Spot TreatmentACNE TREATMENTCosMedical Technologies23bde802-d84a-1ecc-e054-00144ff88e882025-11-13WarningsExact identifier
application number: M006
Personox Ultimate Scrub CleanserSALICYLIC ACIDStonebridge Consultants LLC2b8b5134-ad05-3345-e063-6294a90a87512025-11-12WarningsExact identifier
application number: M006
Clinicians ComplexSULFURCosmed Dermaceuticals, Inc.256e3e4e-2219-45f8-ab78-a6a541767de82025-11-11WarningsExact identifier
application number: M006
CLEARSYNERGYSALICYLIC ACIDSRL ENTERPRISES LLCdf0a4398-4c21-421a-a7dd-92149b1dc8a62025-11-11WarningsExact identifier
application number: M006
Clinicians ComplexSULFURSkinSx.com, Inc.0f13770a-774b-49ad-8417-02928371682a2025-11-11WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053330sulfur 10 % Medicated Liquid SoapPSN3a323a77-eff4-973f-e063-6394a90a02a01
1053330sulfur 100 MG/ML Medicated Liquid SoapSCD3a323a77-eff4-973f-e063-6394a90a02a01
1053330sulfur 10 % Medicated Liquid SoapSY3a323a77-eff4-973f-e063-6394a90a02a01
1053330sulfur 10 % Topical MaskSY3a323a77-eff4-973f-e063-6394a90a02a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85424-003-0185424000301232 g in 1 CARTON (85424-003-01) 232 g2025-08-01NoNoCurrent