RoyceDerm Anti-Fungal Cream

Product NDC
85424-021
11-digit product format
854240021
Labeler code
85424
Product ID
85424-021_4e861073-88e9-b2f7-e063-6394a90ab94a
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate 2%
Dosage form
CREAM
Route
TOPICAL
Labeler
RoyceDerm LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-24
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RoyceDerm Anti-Fungal Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998483

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-021-01RoyceDerm Anti-Fungal Cream100 g in 1 CARTONCREAM1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN4e861073-88e8-b2f7-e063-6394a90ab94a1
998483miconazole nitrate 20 MG/ML Topical CreamSCD4e861073-88e8-b2f7-e063-6394a90ab94a1
998483miconazole nitrate 2 % Topical CreamSY4e861073-88e8-b2f7-e063-6394a90ab94a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85424-021-0185424002101100 g in 1 CARTON (85424-021-01) 100 g2026-04-24NoNoHistorical