roycederm tinea antifungal cream

Generic: miconazole nitrate 2%

Labeler: roycederm llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name roycederm tinea antifungal cream
Generic Name miconazole nitrate 2%
Labeler roycederm llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

miconazole nitrate 20 mg/g

Manufacturer
RoyceDerm LLC

Identifiers & Regulatory

Product NDC 85424-011
Product ID 85424-011_40089a7d-c894-4e90-e063-6294a90aa6f9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2025-10-07

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85424011
Hyphenated Format 85424-011

Supplemental Identifiers

RxCUI
998483
UPC
0196852127900
UNII
VW4H1CYW1K

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name roycederm tinea antifungal cream (source: ndc)
Generic Name miconazole nitrate 2% (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 57 g in 1 TUBE (85424-011-01)
source: ndc

Packages (1)

85424-011-01 57 g in 1 TUBE (85424-011-01)

Ingredients (1)

miconazole nitrate (20 mg/g)

Linked Drug Pages (1)

RoyceDerm Tinea Antifungal Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "40089a7d-c894-4e90-e063-6294a90aa6f9", "openfda": {"upc": ["0196852127900"], "unii": ["VW4H1CYW1K"], "rxcui": ["998483"], "spl_set_id": ["40089a7d-c893-4e90-e063-6294a90aa6f9"], "manufacturer_name": ["RoyceDerm LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "57 g in 1 TUBE (85424-011-01)", "package_ndc": "85424-011-01", "marketing_start_date": "20251007"}], "brand_name": "RoyceDerm Tinea Antifungal Cream", "product_id": "85424-011_40089a7d-c894-4e90-e063-6294a90aa6f9", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "85424-011", "generic_name": "Miconazole nitrate 2%", "labeler_name": "RoyceDerm LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "RoyceDerm Tinea Antifungal Cream", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "20 mg/g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251007", "listing_expiration_date": "20261231"}