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miconazole 1
Miconazole nitrate · Kit
Overview
Forms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| 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| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection
Purpose
openFDA Drug LabelingPurpose Vaginal antifungal Vaginal antifungal
Dosage and Administration
openFDA Drug LabelingDirections • 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo not use if you have never had a vaginal yeast infection diagnosed by a doctor.
Ask a Doctor
openFDA Drug LabelingAsk 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
openFDA Drug LabelingStop 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 LabelingActive ingredients Miconazole nitrate 1200 mg (in vaginal insert) Miconazole nitrate 2% (external cream)
Packaging and NDCs
Source: NDC Directory| 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
| 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.