antifungal cream

Generic: miconazole nitrate

Labeler: encube ethicals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name antifungal cream
Generic Name miconazole nitrate
Labeler encube ethicals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

miconazole nitrate 2 g/100g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-095
Product ID 21922-095_7d6e5fac-1b6c-49df-8a84-7702c4821c31
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2025-03-06

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922095
Hyphenated Format 21922-095

Supplemental Identifiers

RxCUI
998483
UPC
0321922095067
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 antifungal cream (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (21922-095-06) / 42.5 g in 1 TUBE
source: ndc

Packages (1)

21922-095-06 1 TUBE in 1 CARTON (21922-095-06) / 42.5 g in 1 TUBE

Ingredients (1)

miconazole nitrate (2 g/100g)

Linked Drug Pages (1)

Antifungal Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "7d6e5fac-1b6c-49df-8a84-7702c4821c31", "openfda": {"upc": ["0321922095067"], "unii": ["VW4H1CYW1K"], "rxcui": ["998483"], "spl_set_id": ["8be4bbfa-424c-4ccf-b8bc-65b16c126053"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-095-06)  / 42.5 g in 1 TUBE", "package_ndc": "21922-095-06", "marketing_start_date": "20250306"}], "brand_name": "Antifungal Cream", "product_id": "21922-095_7d6e5fac-1b6c-49df-8a84-7702c4821c31", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "21922-095", "generic_name": "Miconazole Nitrate", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Antifungal Cream", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "2 g/100g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250306", "listing_expiration_date": "20261231"}