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 46 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gly-Sal 10-2SALICYLIC ACIDTopiderm, Inc.661cc58b-9360-4b96-b405-afdc2e3783972024-06-13WarningsExact identifier
application number: M006
BLAIR and JACK Anti-Bump Acne TreatmentBENZOYL PEROXIDEBlair + Jackaa8df86a-639c-4416-aadf-4b58566ed9f12024-06-11WarningsExact identifier
application number: M006
b pure Blemish Concealer for Acne Prone Skin NudeSALICYLIC ACIDFourstar Group USA, Inc.76e91277-1fb4-490b-b351-39d626bc1fc22024-06-11WarningsExact identifier
application number: M006
b pure Blemish Concealer for Acne Prone Skin FairSALICYLIC ACIDFourstar Group USA, Inc.764599e5-2ec3-4223-819e-36415fd915f72024-06-11WarningsExact identifier
application number: M006
Dr. Zenovia Acne CleanserBENZOYL PEROXIDETopiderm, Inc.00fb1ee5-6076-4980-8507-9e58a96e6a6b2024-06-11WarningsExact identifier
application number: M006
Dr. Zenovia Spot TreatmentBENZOYL PEROXIDETopiderm, Inc.dfdb3d8e-4d39-4ce4-851f-80b11972ca9e2024-06-11WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDENuCare Pharmaceuticals,Inc.69bd4f4c-017a-7422-e053-2991aa0aa6552024-06-10WarningsExact identifier
application number: M006
Thayers Natural Remedies Since 1847 Rapid Acne TreatmentSULFURL'Oreal USA Products Incd7cc3c06-2f89-4c0b-b121-fdd53638b6252024-06-07WarningsExact identifier
application number: M006
Differin 10% BPO Acne TreatmentBENZOYL PEROXIDEGalderma Laboratories, L.P.05468eab-f239-42cb-9106-055a105f0fa52024-06-06WarningsExact identifier
application number: M006
2.5 Acne MedBENZOYL PEROXIDEFace Reality, Inc.58a7f677-996c-4951-8e5d-b5556244f8002024-06-05WarningsExact identifier
application number: M006
10 Acne MedBENZOYL PEROXIDEFace Reality, Inc.91791905-086f-44cf-9c1a-e9f132c6c11b2024-06-05WarningsExact identifier
application number: M006
Walgreens Oil-Free Acne Wash Salicylic AcidSALICYLIC ACIDWalgreen Company9f311567-caa2-4302-9cf8-8c341917d16e2024-06-03WarningsExact identifier
application number: M006
Walgreens Maximum Strength Acne Treatment Acne medicationBENZOYL PEROXIDEWalgreen Company72ca0ddd-9292-48c9-9189-532a1768c9b72024-06-03WarningsExact identifier
application number: M006
Derma E Acne Matte MoisturizerSALICYLIC ACIDderma e48fd8477-b880-4a31-9227-095d38a7eac52024-05-31WarningsExact identifier
application number: M006
LACTO-S ACNE TREATMENTSALICYLIC ACIDNoon Aesthetics M.R. Ltdea0c7fda-30a0-48df-8a1b-4d6098c0081e2024-05-31WarningsExact identifier
application number: M006
Derma E Acne Cleansing PadsSALICYLIC ACIDderma ec749a11f-daa1-4d76-b818-cd6509efaceb2024-05-28WarningsExact identifier
application number: M006
ULTA All Clear SERUMSALICYLIC ACIDAPR BEAUTY GROUP INC199a96c1-94b8-3de6-e063-6394a90ab4782024-05-28WarningsExact identifier
application number: M006
Crystal Clear Acne Treatment PadsSALICYLIC ACIDSkin Pharm, LLC0469b1ab-5cfb-416a-b34b-7dc6fef611ff2024-05-22WarningsExact identifier
application number: M006
Anti-Aging Blemish Control Peel PadsSALICYLIC ACIDJune Jacobs Labs, LLC18fa83ab-1712-398c-e063-6394a90a6b792024-05-21WarningsExact identifier
application number: M006
Peace Out AcneSALICYLIC ACIDPeace Out LLC.efa796e8-62a8-6c20-e053-2a95a90aef6f2024-05-20WarningsExact 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