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Miconazole 3

Miconazole Nitrate · Cream

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Miconazole 3
Generic name
Miconazole Nitrate
Dosage form
Cream
Route
Vaginal
Marketing category
ANDA · ANDA
Labeler
TARGET Corporation
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
2
Packages
2
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Miconazole Nitrate 40 mg/g 992765 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Cream
Route of administration
Vaginal
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Azole Antifungal [EPC] EPC All 44 members
Azoles [CS] CS All 44 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
076773
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 2, 2005
Sponsor
SUN PHARMA CANADA
Products on application
1
Submissions recorded
1
Products approved under application 076773.
Product Trade name Form Strength Ingredient Status TE Flags
076773-001 MICONAZOLE 3 CREAM MICONAZOLE NITRATE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 076773.
Type No. Action Status Date Review
Original application 1 Approved March 2, 2005 —

Review documents

  • 0 · Original application · March 3, 2005

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250718). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250718 HUMAN OTC DRUG · 20250127

Indications and Usage

openFDA Drug Labeling

Uses • treats vaginal yeast infections

Purpose Vaginal antifungal

Dosage and Administration

openFDA Drug Labeling

Directions • before using this product read the enclosed consumer information leaflet for complete directions and information • adults and children 12 years of age and over: • insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use. • children under 12 years of age: ask a doctor

Warnings For vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor. Ask a doctor before use if you have • vaginal itching and discomfort for the first time • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. • been exposed to the human immunodeficiency virus (HIV) that causes AIDS Ask a doctor pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur. When using this product • do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). • do not have vaginal intercourse • mild increase in vaginal burning, itching or irritation may occur • if you do not get complete relief ask a doctor before using another product Stop use and ask a doctor if: • symptoms do not get better in 3 days • symptoms last more than 7 days • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have • vaginal itching and discomfort for the first time • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Stop use and ask a doctor if: • symptoms do not get better in 3 days • symptoms last more than 7 days • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

Active Ingredient

openFDA Drug Labeling

Active ingredient Miconazole nitrate USP 4%

Adverse event reports

Source: openFDA FAERS
8,749
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: MICONAZOLE NITRATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
11673-391-06 11673-391 TARGET Corporation 1 TUBE, WITH APPLICATOR in 1 CARTON (11673-391-06) / 25 g in 1 TUBE, WITH APPLICATOR October 14, 2020
0363-2070-14 0363-2070 Walgreen Company 3 APPLICATOR in 1 CARTON (0363-2070-14) / 5 g in 1 APPLICATOR June 15, 2018
11673-391 11673-391 TARGET Corporation — March 2, 2005
0363-2070 0363-2070 Walgreen Company — June 15, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.