FDA.reportPublic FDA data

RoyceDerm Rosacea Relief Cream.

Product NDC
85424-018
11-digit product format
854240018
Labeler code
85424
Product ID
85424-018_4c3f6332-de47-f107-e063-6294a90ad63f
Type
HUMAN OTC DRUG
Nonproprietary name
Sulfur 1X HPUS 10%
Dosage form
CREAM
Route
TOPICAL
Labeler
RoyceDerm LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-26
Substance
SULFUR
Active strength
1 [hp_X]/114g
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 Rosacea Relief Cream.
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFUR1 [hp_X]/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
4c3f6332-de46-f107-e063-6294a90ad63fAvailable 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
85424-018-01RoyceDerm Rosacea Relief 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 53 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HUMANE ACNE WASHBENZOYL PEROXIDEApprendista, LLC1d25fb25-a3d2-4c6b-a975-be7b90b702652023-11-05WarningsExact identifier
application number: M006
VIE NATURELLE ACNE BODYBENZOYL PEROXIDETNT PRO SERIES0278251d-bcf1-4177-8a57-163bd0f2df002023-11-05WarningsExact identifier
application number: M006
enfuselle Acne ClarifyingSALICYLIC ACIDShaklee Corporationdd429a9b-5c2d-4310-8506-6487b02e38802023-11-03WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Exfoliating tonerSALICYLIC ACIDPeach & Lily Inc.ba70ed1c-83cb-5eaa-e053-2a95a90a92cc2023-10-28WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Clarifying CleanserSALICYLIC ACIDPeach & Lily, Inc.ba70f2b9-7a34-065c-e053-2a95a90a6eb22023-10-28WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Oil Acne Free MoisturizerSALICYLIC ACIDPeach & Lily, Inc.ba70e7cf-af86-6a7f-e053-2995a90af9622023-10-28WarningsExact identifier
application number: M006
Modesa Acne TreatmentBENZOYL PEROXIDEZhejiang Jingwei Pharmaceutic Al Co., Ltd.dbfe8b9e-e343-4ed5-bd81-01b27b4aa9122023-10-27WarningsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEVivier Pharma, Inc.b4844539-bdd2-42a6-b946-6028de4f3cf12023-10-27WarningsExact identifier
application number: M006
Acne Treatment SystemBENZOYL PEROXIDE, SALICYLIC ACIDVivier Pharma, Inc.d39ee6a2-5d65-4198-82d9-deb83471f3122023-10-27WarningsExact identifier
application number: M006
Equate Beauty Quick Action Pads Salicylic Acid Acne TreatmentSALICYLIC ACIDBath Concept Cosmetics (Dongguan) Co., Ltdc94e85a7-b799-b70d-e053-2a95a90aaee22023-10-26WarningsExact identifier
application number: M006
ARTISTRY STUDiO Rose All Day Anti Acne Toner Pore RefresherSALICYLIC ACIDAccess Business Group LLCa9e26804-7989-41d2-8506-c4b65ca385b72023-10-21WarningsExact identifier
application number: M006
Artistry Studio Done With Zit Acne Treatment Clearing GelSALICYLIC ACIDAccess Business Group LLC7a9bb4a0-c463-44e8-90a3-12bd58829f9d2023-10-21WarningsExact identifier
application number: M006
PERSISTENT BODY ACNE WASH 8.5OZSALICYLIC ACIDChina Ningbo Shangge Cosmetics Technology Corp.074079cd-866d-0af0-e063-6394a90a72142023-10-09WarningsExact identifier
application number: M006
Skin Laundry. Clean Slate Exfoliating 2 Salicylic Acid Treatment Gel Cleanser Cleanse ExfoliateSALICYLIC ACIDSkin Laundry Holdings, Inc.07100fe5-3884-0948-e063-6294a90a6ec72023-10-06WarningsExact identifier
application number: M006
NAS PORE REFINING SCRUBSALICYLIC ACIDBURT'S BEES, INC.bc2c6b1e-999c-91a7-e053-2a95a90a9d1a2023-10-05WarningsExact identifier
application number: M006
NAS Targeted Spot TreatmentSALICYLIC ACIDBurt's Beesbc193e1f-c2bd-6415-e053-2995a90ae6eb2023-10-05WarningsExact identifier
application number: M006
ACNE AND LINE CORRECTING SERUMSALICYLIC ACIDCLINIQUE LABORATORIES LLCb03bdef4-a099-4543-8673-85466bd649612023-10-05WarningsExact identifier
application number: M006
SPOT ACNE TREATMENT 0.75OZBENZOYL PEROXIDERejoice International Corp.06de40a2-45bf-bf4b-e063-6294a90a586c2023-10-04WarningsExact identifier
application number: M006
PERSISTENT BODY ACNE WASH 8.5OZSALICYLIC ACIDRejoice International Corp.06df07f7-e4c5-ccef-e063-6394a90a9f3c2023-10-04WarningsExact identifier
application number: M006
SPOT ACNE TREATMENT 0.75OZBENZOYL PEROXIDEChina Ningbo Shangge Cosmetics Technology Corp.06e07266-6483-e7ef-e063-6294a90a93952023-10-04WarningsExact identifier
application number: M006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85424-018-0185424001801114 g in 1 CARTON (85424-018-01) 114 g2026-03-26NoNoCurrent