desenex

Generic: miconazole nitrate

Labeler: crown laboratories
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name desenex
Generic Name miconazole nitrate
Labeler crown laboratories
Dosage Form POWDER
Routes
TOPICAL
Active Ingredients

miconazole nitrate 20 mg/g

Manufacturer
Crown Laboratories

Identifiers & Regulatory

Product NDC 0316-0225
Product ID 0316-0225_4833f384-eb1d-0049-e063-6394a90a9f53
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2027-12-31
Marketing Start 2023-10-19

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03160225
Hyphenated Format 0316-0225

Supplemental Identifiers

RxCUI
998461 998465
UPC
0303160225154
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 desenex (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/g
source: ndc
Packaging
  • 43 g in 1 BOTTLE, PLASTIC (0316-0225-01)
  • 85 g in 1 BOTTLE, PLASTIC (0316-0225-02)
source: ndc

Packages (2)

0316-0225-01 43 g in 1 BOTTLE, PLASTIC (0316-0225-01) 0316-0225-02 85 g in 1 BOTTLE, PLASTIC (0316-0225-02)

Ingredients (1)

miconazole nitrate (20 mg/g)

Linked Drug Pages (1)

Desenex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4833f384-eb1d-0049-e063-6394a90a9f53", "openfda": {"upc": ["0303160225154"], "unii": ["VW4H1CYW1K"], "rxcui": ["998461", "998465"], "spl_set_id": ["09964187-12f1-bbe6-e063-6394a90acba0"], "manufacturer_name": ["Crown Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "43 g in 1 BOTTLE, PLASTIC (0316-0225-01)", "package_ndc": "0316-0225-01", "marketing_start_date": "20231019"}, {"sample": false, "description": "85 g in 1 BOTTLE, PLASTIC (0316-0225-02)", "package_ndc": "0316-0225-02", "marketing_start_date": "20231019"}], "brand_name": "Desenex", "product_id": "0316-0225_4833f384-eb1d-0049-e063-6394a90a9f53", "dosage_form": "POWDER", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "0316-0225", "generic_name": "MICONAZOLE NITRATE", "labeler_name": "Crown Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Desenex", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "20 mg/g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231019", "listing_expiration_date": "20271231"}