FDA.reportPublic FDA data

RoyceDerm Rosacea Treatment Cream.

Product NDC
85424-009
11-digit product format
854240009
Labeler code
85424
Product ID
85424-009_3df717fc-cf30-8a9a-e063-6394a90ae4e2
Type
HUMAN OTC DRUG
Nonproprietary name
Sulphur 1X HPUS(10%)
Dosage form
CREAM
Route
TOPICAL
Labeler
RoyceDerm LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-30
Substance
SULFUR
Active strength
11.4 g/114g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RoyceDerm Rosacea Treatment Cream.
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR11.4 g/114g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3df717fc-cf2f-8a9a-e063-6394a90ae4e2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-009-01RoyceDerm Rosacea Treatment Cream.114 g in 1 CARTONCREAM1141

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 1 of 55 · 1,083 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PIMPLE PATCHESPIMPLE PATCHESShenzhen Hengdasheng Technology Co., Ltd584d3833-4593-94db-e063-6294a90ad3ff2026-08-05WarningsExact identifier
application number: M006
Acne Clearing Sulfur MaskSULFURAcneFree, LLCc0675282-ff00-edba-e053-2995a90ace682026-07-31WarningsExact identifier
application number: M006
Sulfur Acne Foaming CleanserSULFURAcne Free, LLCfeb82a3d-cda3-c62a-e053-6394a90ad9bb2026-07-31WarningsExact identifier
application number: M006
Acne Free BLACKHEAD REMOVING SCRUB 2 Salicylic Acid with CharcoalSALICYLIC ACIDAcneFree LLCc9393340-8a5f-6b7c-e053-2995a90afcd92026-07-31WarningsExact identifier
application number: M006
AMBI Even and Clear Exfoliating Wash Acne TreatmentSALICYLIC ACIDAMBI ENTERPRISES, LLC43a4712d-9a6d-4bfc-abe4-f6e81dca35492026-07-31WarningsExact identifier
application number: M006
Acne Free Free 24 HR Acne Clearing SystemBENZOYL PEROXIDEAcneFree, LLCc939847a-72eb-96fa-e053-2a95a90a4f9c2026-07-31WarningsExact identifier
application number: M006
Terminator 10BENZOYL PEROXIDEAcneFree, LLCc06778b6-0ed6-7d82-e053-2a95a90a2ef82026-07-31WarningsExact identifier
application number: M006
Acne Free Oil Free Acne Cleanser 2.5 Benzoyl PeroxideBENZOYL PEROXIDEAcneFree LLCc939847a-72cc-96fa-e053-2a95a90a4f9c2026-07-31WarningsExact identifier
application number: M006
Benzoyl Peroxide Deep Cleansing Foaming WashBENZOYL PEROXIDEAcneFree, LLCfe2d0e24-8c68-b2ea-e053-6294a90ad72c2026-07-31WarningsExact identifier
application number: M006
Salicylic AcidSALICYLIC ACIDAcne Free, LLC1097fc73-fa47-0f14-e063-6294a90aa4992026-07-31WarningsExact identifier
application number: M006
Even and Clear CleanserSALICYLIC ACIDAmbi Enterprises LLCbff537cf-aa79-5250-e053-2995a90a388a2026-07-31WarningsExact identifier
application number: M006
Oil Free Deep Cleansing Duo Cleansing Brush Oil Free Acne CleanserBENZOYL PEROXIDEAcneFree, LLCc7a675fa-b6c0-6237-e053-2a95a90a04062026-07-31WarningsExact identifier
application number: M006
Acne Free SEVERE ACNE 24 HR Acne Clearing SystemBENZOYL PEROXIDEAcneFree, LLCc939681e-ea93-31ce-e053-2a95a90a8c702026-07-31WarningsExact identifier
application number: M006
Acne Free SENSITIVE SKIN 24 HR Acne Clearing SystemSALICYLIC ACID, BENZOYL PEROXIDEAcneFree LLCc9397a25-8fed-48d0-e053-2a95a90ab4952026-07-31WarningsExact identifier
application number: M006
sulfur acne treatmentSULFURAcne Free105545d8-974c-5a9a-e063-6294a90aecc42026-07-31WarningsExact identifier
application number: M006
24 Hour Sensitive Skin Acne Clearing SystemSALICYLIC ACIDAcne Free LLC39ea674d-ff6e-a8c6-e063-6394a90a06562026-07-31WarningsExact identifier
application number: M006
cardae FOLLICULITIS CreamMICONAZOLE NITRATE 2% FOLLICULITIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.57e0be6a-3141-f3b6-e063-6394a90a15202026-07-30WarningsExact identifier
application number: M006
SKINTIFIC 3X ACID INTENSIVE ACNE TREATMENTSALICYLIC ACIDGold Inti Trade Corporation57a7c929-31f5-ef82-e063-6394a90ab9af2026-07-28WarningsExact identifier
application number: M006
BellamiLuxx Butt Acne Treatment CreamSALICYLIC ACID 2%BellamiLuxx LLC42f3367f-40a2-5d97-e063-6294a90a6e332026-07-28WarningsExact identifier
application number: M006
Acne Treatment with SulfurSULFURDLC Laboratories, Inc.4a1591e8-6135-4b22-b54c-5553c2dc05402026-07-28WarningsExact identifier
application number: M006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85424-009-0185424000901114 g in 1 CARTON (85424-009-01) 114 g2025-09-30NoNoCurrent