FDA.reportPublic FDA data

RoyceDerm Anti fungal RELIEF cream

Product NDC
85424-013
11-digit product format
854240013
Labeler code
85424
Product ID
85424-013_47ec6277-e410-af82-e063-6294a90ac8c1
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid 2%
Dosage form
CREAM
Route
TRANSDERMAL
Labeler
RoyceDerm LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-23
Substance
ARTEMISIA AFRA TOP; SALICYLIC ACID
Active strength
3; 2 g/100g; g/100g
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 Anti fungal RELIEF cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARTEMISIA AFRA TOP3 g/100g
SALICYLIC ACID2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FCU6WET6AAInternal UNII lookup
O414PZ4LPZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47ec6277-e40f-af82-e063-6294a90ac8c1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-013-01RoyceDerm Anti fungal RELIEF cream100 g in 1 CARTONCREAM1001

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 37 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Jock ItchCLOTRIMAZOLEKroger Companycc536b67-8b0b-4939-b0fb-9a9e4188c4e52025-07-08WarningsExact identifier
application number: M005
Rite Aid antifungal ringwormCLOTRIMAZOLERite Aid Corporation1ad7cd82-d01b-403e-a2c1-2302db2a78df2025-07-08WarningsExact identifier
application number: M005
ConazolMICONAZOLE NITRATELaboratorios Liomont, S.A. de C.V.84780538-8618-5750-e053-2a91aa0a60542025-07-07WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLESTRATEGIC SOURCING SERVICES LLC9aba1345-ef47-4951-8448-a43d6696b6162025-07-07WarningsExact identifier
application number: M005
sunmark antifungalTOLNAFTATEStrategic Sourcing Services LLCd0c30c74-9472-4978-9623-8c7dbeb994112025-07-07WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.a3a5cbf5-cabb-48d8-8877-74a97f7c0f572025-07-03WarningsExact identifier
application number: M005
OMZOK ANTIFUNGAL PENUNDECYLENIC ACID 25%Shenzhen Shandian Jingling Technology Co., Ltd.38edf699-93af-e550-e063-6294a90a368c2025-07-02WarningsExact identifier
application number: M005
meijer Athletes FootCLOTRIMAZOLEMeijer Distribution Incfdb15cd8-6726-4150-9b9d-6ef3ee01a5d22025-07-02WarningsExact identifier
application number: M005
meijer antifungalTOLNAFTATEMeijer Distribution Inc374af35a-b8bb-4784-bfc8-c3342de875ca2025-07-02WarningsExact identifier
application number: M005
Rexall Jock ItchCLOTRIMAZOLEDollar General11427a79-f262-4702-9b2e-ec1955a9b2da2025-07-02WarningsExact identifier
application number: M005
Rexall Athletes FootCLOTRIMAZOLEDollar General664579a1-a5b0-4a4c-bff6-4347f3e1d3bb2025-07-02WarningsExact identifier
application number: M005
Athletes Foot AntifungalTOLNAFTATEDollar General43fc473e-c1fd-4245-af38-2e9de5ad91dc2025-07-02WarningsExact identifier
application number: M005
SEFUDUN FUNGAL NAIL PATCHESGLYCERINShenzhen Shandian Jingling Technology Co., Ltd.38db97d6-27c8-da99-e063-6294a90aac662025-07-01WarningsExact identifier
application number: M005
Tolnaftate AntifungalTOLNAFTATESun Pharmaceutical Industries, Inc.fa16fa08-fbbd-4f45-b64a-9bffe78e88612025-07-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEGranules Pharmaceuticals Inc.1280353c-9f96-557e-e063-6294a90a10f92025-06-30WarningsExact identifier
application number: M005
MiconazoleMICONAZOLE NITRATEChain Drug Consortium, LLC246be926-79ea-4e0c-a3ef-2aa7fc3a52bf2025-06-30WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL LIQUID CONTINUOUS SPRAYChain Drug Consortium, LLC7f6912a6-a576-4138-bd78-a075a7d240362025-06-27WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYRite Aid Corporationaee58c44-5dba-8acb-e053-2a95a90a23af2025-06-21WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREERite Aid Corporation5e2f2372-4b79-4b6a-bdea-74289b1e20532025-06-21WarningsExact identifier
application number: M005
TolnaftateJOCK ITCH POWDERRite Aid Corporationb6968587-45c2-d2f8-e053-2a95a90a84012025-06-21WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85424-013-0185424001301100 g in 1 CARTON (85424-013-01) 100 g2026-01-23NoNoCurrent