On this page

miconazole 1

Miconazole nitrate · Kit

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.

Overview

Brand name
miconazole 1
Generic name
Miconazole nitrate
Dosage form
Kit
Route
—
Marketing category
ANDA · ANDA
Labeler
Kroger Company
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
6
Packages
6
Data completeness
82% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
—
Presentations
12

Regulatory status

Source: Drugs@FDANDC Directory
Application number
079114
Application type
ANDA · Abbreviated New Drug Application
Approval date
June 2, 2010
Sponsor
PERRIGO R AND D
Products on application
2
Submissions recorded
3
Products approved under application 079114.
Product Trade name Form Strength Ingredient Status TE Flags
079114-001 MICONAZOLE NITRATE CREAM, INSERT MICONAZOLE NITRATE Over-the-counter —
079114-002 MICONAZOLE NITRATE CREAM MICONAZOLE NITRATE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 079114.
Type No. Action Status Date Review
Supplement 14 Labeling Approved June 11, 2020 Standard
Supplement 6 Labeling Approved August 25, 2017 Standard
Original application 1 Approved June 2, 2010 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260811). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260811 HUMAN OTC DRUG · 20260803 HUMAN OTC DRUG · 20260123

Indications and Usage

openFDA Drug Labeling

Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection

Purpose Vaginal antifungal 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: • vaginal insert: with the applicator, place the vaginal insert into the vagina. Throw applicator away. • external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed. • 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 or 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 ingredients Miconazole nitrate 1200 mg (in vaginal insert) Miconazole nitrate 2% (external cream)

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
59779-199-00 59779-199 CVS Pharmacy 1 KIT in 1 CARTON (59779-199-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE June 8, 2010
37808-199-00 37808-199 H E B 1 KIT in 1 CARTON (37808-199-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE June 7, 2010
30142-199-00 30142-199 Kroger Company 1 KIT in 1 CARTON (30142-199-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE June 8, 2010
41250-199-00 41250-199 Meijer Distribution Inc 1 KIT in 1 CARTON (41250-199-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE June 11, 2010
21130-929-00 21130-929 Safeway 1 KIT in 1 CARTON (21130-929-00) * 1 SUPPOSITORY in 1 POUCH (0113-3023-00) * 1 TUBE in 1 CARTON (0113-8123-00) / 9 g in 1 TUBE April 15, 2026
0363-5201-01 0363-5201 WALGREEN COMPANY 1 KIT in 1 PACKAGE, COMBINATION (0363-5201-01) * 1 SUPPOSITORY in 1 POUCH (0363-5204-01) * 9 g in 1 TUBE (0363-5205-01) November 30, 2021
59779-199 59779-199 CVS Pharmacy — June 8, 2010
37808-199 37808-199 H E B — June 7, 2010
30142-199 30142-199 Kroger Company — June 8, 2010
41250-199 41250-199 Meijer Distribution Inc — June 11, 2010
21130-929 21130-929 Safeway — April 15, 2026
0363-5201 0363-5201 WALGREEN COMPANY — November 30, 2021

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

Generated September 25, 2026 · 7 sections on this page.