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Miconazole

Generic Name
Miconazole
Brand Names
Aloe Vesta Antifungal, Baza, Critic-aid Clear, Desenex, Fungoid, Inzo, Lagicam, Lotrimin AF, Micatin, Micro-guard, Monistat, Monistat 1 Day Ovule Combination Pack, Monistat 3 Day Ovule Combination Pack, Monistat 7 Combination Pack, Oravig, Rash Relief Antifungal, Remedy Antifungal, Tetterine, Tineacide Antifungal, Ting, Vagistat, Vagistat 3 Day Combination Pack, Vusion, Zeasorb
Drug Type
Small Molecule
Chemical Formula
C18H14Cl4N2O
CAS Number
22916-47-8
Unique Ingredient Identifier
7NNO0D7S5M

Overview

Miconazole is a broad-spectrum azole antifungal with some activity against Gram-positive bacteria as well. It is widely used to treat mucosal yeast infections, including both oral and vaginal infections; although intravenous miconazole is no longer available, a wide variety of suppositories, creams, gels, and tablet-based products are available. Miconazole is thought to act primarily through the inhibition of fungal CYP450 14α-lanosterol demethylase activity. Miconazole was first synthesized in 1969 and first granted FDA approval on January 8, 1974, for sale by INSIGHT Pharmaceuticals as a topical cream. It is currently available as a variety of prescription and over the counter products. Despite having been in clinical use for an extended period, resistance to miconazole among susceptible organisms is relatively low.

Background

Miconazole is a broad-spectrum azole antifungal with some activity against Gram-positive bacteria as well. It is widely used to treat mucosal yeast infections, including both oral and vaginal infections; although intravenous miconazole is no longer available, a wide variety of suppositories, creams, gels, and tablet-based products are available. Miconazole is thought to act primarily through the inhibition of fungal CYP450 14α-lanosterol demethylase activity. Miconazole was first synthesized in 1969 and first granted FDA approval on January 8, 1974, for sale by INSIGHT Pharmaceuticals as a topical cream. It is currently available as a variety of prescription and over the counter products. Despite having been in clinical use for an extended period, resistance to miconazole among susceptible organisms is relatively low.

Indication

Miconazole is indicated for the local treatment of oropharyngeal candidiasis in adult patients and for the adjunctive treatment of diaper dermatitis complicated by candidiasis in immunocompetent patients aged four weeks and older. Miconazole is available as both a suppository and cream for the treatment of vaginal yeast infections and the relief of associated vulvar itching and irritation. Lastly, miconazole cream is effective in treating athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm infections (tinea corporis), pityriasis (formerly tinea) versicolor, and cutaneous candidiasis.

Associated Conditions

  • Acne Vulgaris
  • Dermatophytosis
  • Dermatophytosis of nail
  • Diaper Dermatitis
  • Excessive sweating and body odor
  • Fungal skin infection
  • Gastrointestinal candidiasis
  • Infection, Mixed
  • Infections, Fungal of the Skin Folds
  • Nail candida
  • Oropharyngeal Candidiasis
  • Pityriasis versicolor
  • Ringworm
  • Seborrheic Dermatitis
  • Skin candida
  • Tinea Capitis
  • Tinea Corporis
  • Tinea Cruris
  • Tinea Pedis
  • Vaginal Candidiasis
  • Cutaneous candidiasis

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Dechra Veterinary Products
17033-175
TOPICAL
20 mg in 1 mL
6/6/2025
Sun Pharmaceutical Industries, Inc.
51672-2035
VAGINAL
20 mg in 1 g
5/27/2025
VIVE HEALTH LLC
84722-3060
TOPICAL
2 g in 100 g
4/28/2025
Physicians Total Care, Inc.
54868-6246
TOPICAL
2.5 mg in 1 g
4/20/2011
Rida LLC
83004-025
TOPICAL
2 g in 100 mL
5/28/2025
Mylan Pharmaceuticals Inc.
0378-8222
TOPICAL
2.5 mg in 1 g
8/14/2018
Jiangxi Yudexi Pharmaceutical Co., LTD
85248-007
TOPICAL
0.1 g in 100 g
5/28/2025
Preferred Pharmaceuticals Inc.
68788-8845
TOPICAL
2 g in 100 g
3/24/2025
Chain Drug Marketing Association
83324-233
TOPICAL
20 mg in 1 g
5/1/2025

EMA Drug Approvals

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Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
DAKTARIN ORAL GEL 2%
SIN01115P
GEL
2% w/w
5/12/1988
NEO-PENOTRAN PESSARY
SIN11180P
SUPPOSITORY
100 mg
10/7/1999
DAKTARIN CREAM 20 mg/g
SIN02028P
CREAM
20 mg/g
6/23/1988
MICON-H CREAM
SIN06454P
CREAM
2% w/w
7/17/1991
RESOLVE PLUS 1.0
SIN11900P
CREAM
2% w/w
4/26/2002
MINAZOL POWDER 2% w/w
SIN07023P
POWDER
2% w/w
6/3/1992
ZARIN CREAM 2%
SIN00962P
CREAM
2.00% w/w
5/10/1988
DAKTARIN POWDER 2%
SIN01114P
POWDER
20 mg/g
5/12/1988
ZARICORT CREAM
SIN03840P
CREAM
2% w/w
2/10/1990
DTC Anti-Fungal & White Spot Cream
SIN13771P
CREAM
2% w/w
3/2/2010

NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Miconazole Nitrate Vaginal Soft Capsules
国药准字J20140135
生物制品
胶囊剂
9/5/2019
Miconazole Nitrate Vaginal Soft Capsules
国药准字HJ20160008
化学药品
胶囊剂
11/17/2020
Miconazole Nitrate Vaginal Soft Capsules
H20140489
化学药品
胶囊剂
7/3/2019
Miconazole Nitrate Vaginal Soft Capsules
国药准字H20173400
化学药品
胶囊剂
9/20/2022
Miconazole Nitrate Vaginal Soft Capsules
国药准字H20058234
化学药品
软胶囊剂
5/12/2020
Miconazole Nitrate Vaginal Soft Capsules
国药准字HJ20160007
化学药品
胶囊剂
11/17/2020
Miconazole Nitrate Vaginal Soft Capsules
H20140488
化学药品
胶囊剂
7/3/2019
Miconazole Nitrate Vaginal Soft Capsules
国药准字H20163009
化学药品
胶囊剂
1/6/2021
Miconazole Nitrate Vaginal Soft Capsules
国药准字H20173399
化学药品
胶囊剂
9/20/2022
Miconazole Nitrate Cream
国药准字H20074079
化学药品
乳膏剂
7/11/2022

PPB Drug Approvals

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TGA Drug Approvals

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