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 12 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne TreatmentBENZOYL PEROXIDETopco Associates LLC8d5e7e40-5e61-470a-b8ff-0b2dca3cabb02026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Daily Acne Control CleanserBENZOYL PEROXIDETopco Associates LLC8474d917-7ee4-4d1d-8499-3520f771d2fd2026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Body WashSALICYLIC ACIDTopco Associates LLC1b16b978-70e0-4bba-a8d7-a77d7e1f896a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDTopco Associates LLCe98a8184-c5a8-4306-9fff-9dc77e9d2d442026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Salicylic AcidASTRINGENTTopco Associates LLC7d15560f-d8d1-4dfe-8eca-b16bb529ad872026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Topco Associates LLC3149260c-b92b-43a7-8f57-897517102fa82026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEWalgreen Co.07721aa6-867a-436f-8c88-ab135f02a6b52026-02-12Warnings, Adverse reactionsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDAmazon.com Services LLC06339296-14e7-4179-aa2f-538bae921a8b2026-02-11Warnings, Adverse reactionsExact identifier
application number: M006
natouchSALICYLIC ACIDNatouch LLC3af85c98-f14d-5857-e063-6394a90aed132026-02-10WarningsExact identifier
application number: M006
ACNE TREATMENTTREATBio Clarity LLC4a7e40c1-7421-a0c7-e063-6294a90a4d6b2026-02-10WarningsExact identifier
application number: M006
HerbaGlow Baiwooxia Anti-Acne GelSALICYLIC ACID GELKungpo Health Care & Herbal Center Inc010029a3-8c1a-4f29-a162-a8ba4f9390582026-02-10WarningsExact identifier
application number: M006
Acne CleanserBENZOYL PEROXIDEWalmart, Inc.04514cbb-6041-4bd5-9ab9-31312b0d8f192026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Salicylic acidSALICYLIC ACIDTopco Associates LLC4a28800d-14ef-d841-e063-6394a90a692b2026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDRetail Business Services, LLC1942bd34-a152-450e-a5c5-46488da66b3d2026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%American Sales Company613f0a91-32d3-4a1e-9c9f-f0167481b5112026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
ACNE DOTS (Skin Care Multi-Pack)SALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.4a0dc951-07ce-2030-e063-6294a90ab2ea2026-02-05WarningsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Publix Super Markets, Inc.169eaaa4-308d-44ba-ad93-3205e0dd9ae12026-02-05Warnings, Adverse reactionsExact identifier
application number: M006
SPOTLESS Daily Acne WashBENZOYL PEROXIDERodan & Fields8f7bb793-3c60-4014-954e-514ef87a44fb2026-02-04WarningsExact identifier
application number: M006
SPOTLESS Acne Clearing TreatmentBENZOYL PEROXIDERodan & Fields3d4ef4ce-9be3-436a-9f93-c01caa93d1a82026-02-04WarningsExact identifier
application number: M006
SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTSBENZOYL PEROXIDERodan & Fields8b2c187d-4b66-4872-8243-4365ea2e8b592026-02-04WarningsExact 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