fifthpulse miconazole nitrate cream 1oz

Generic: miconazole nitrate

Labeler: front pharmaceutical plc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name fifthpulse miconazole nitrate cream 1oz
Generic Name miconazole nitrate
Labeler front pharmaceutical plc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

miconazole nitrate 20 mg/g

Manufacturer
Front Pharmaceutical PLC

Identifiers & Regulatory

Product NDC 69571-016
Product ID 69571-016_3a37a3a8-9d06-926c-e063-6294a90a9ed8
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2025-07-19

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69571016
Hyphenated Format 69571-016

Supplemental Identifiers

RxCUI
998483
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 fifthpulse miconazole nitrate cream 1oz (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
  • 28.4 g in 1 TUBE (69571-016-01)
source: ndc

Packages (1)

69571-016-01 28.4 g in 1 TUBE (69571-016-01)

Ingredients (1)

miconazole nitrate (20 mg/g)

Linked Drug Pages (1)

FifthPulse Miconazole Nitrate Cream 1oz ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3a37a3a8-9d06-926c-e063-6294a90a9ed8", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998483"], "spl_set_id": ["3a37a3a8-9d05-926c-e063-6294a90a9ed8"], "manufacturer_name": ["Front Pharmaceutical PLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28.4 g in 1 TUBE (69571-016-01)", "package_ndc": "69571-016-01", "marketing_start_date": "20250719"}], "brand_name": "FifthPulse Miconazole Nitrate Cream 1oz", "product_id": "69571-016_3a37a3a8-9d06-926c-e063-6294a90a9ed8", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "69571-016", "generic_name": "Miconazole Nitrate", "labeler_name": "Front Pharmaceutical PLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "FifthPulse Miconazole Nitrate Cream 1oz", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "20 mg/g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250719", "listing_expiration_date": "20261231"}