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 Identifiers#

Field, Values table
FieldValues
Unii70FD1KFU70

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

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 g2025-09-30NoNoHistorical