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Miconazole 7
Miconazole Nitrate · Cream
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Azole Antifungal [EPC] | EPC | All 44 members |
| Azoles [CS] | CS | All 44 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 074164-001 | MICONAZOLE 7 | CREAM | MICONAZOLE NITRATE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 33 | Labeling | Approved | April 27, 2022 | Standard |
| Supplement | 27 | Manufacturing (CMC) | Approved | June 8, 2015 | Unknown |
| Supplement | 25 | Labeling | Approved | March 24, 2015 | Standard |
| Supplement | 22 | Labeling | Approved | March 24, 2015 | — |
| Supplement | 10 | Labeling | Approved | November 19, 2001 | — |
| Supplement | 8 | Manufacturing (CMC) | Approved | December 29, 2000 | — |
| Supplement | 6 | Manufacturing (CMC) | Approved | February 17, 2000 | — |
| Supplement | 7 | Manufacturing (CMC) | Approved | December 27, 1999 | — |
| Supplement | 4 | Manufacturing (CMC) | Approved | October 18, 1996 | — |
| Supplement | 3 | Manufacturing (CMC) | Approved | October 18, 1996 | — |
| Supplement | 2 | Manufacturing (CMC) | Approved | October 18, 1996 | — |
| Supplement | 1 | Manufacturing (CMC) | Approved | October 18, 1996 | — |
| Supplement | 5 | Manufacturing (CMC) | Approved | June 28, 1996 | — |
| Original application | 1 | Approved | March 29, 1996 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260820). 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
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: • applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw applicator away after use. • use the same tube of cream if you have itching and irritation on the skin outside the vagina. 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 (1-800-222-1222) right away.
Do Not Use
openFDA Drug LabelingDo not use i f 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, USP 2% (100 mg in each applicator)
Adverse event reports
Source: openFDA FAERSAttributed 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| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 69842-988-07 | 69842-988 | CVS Pharmacy | 1 TUBE, WITH APPLICATOR in 1 CARTON (69842-988-07) / 45 g in 1 TUBE, WITH APPLICATOR | December 15, 2016 |
| 70000-0009-1 | 70000-0009 | Cardinal Health (Leader) 70000 | 1 TUBE, WITH APPLICATOR in 1 CARTON (70000-0009-1) / 45 g in 1 TUBE, WITH APPLICATOR | July 1, 2019 |
| 49035-347-07 | 49035-347 | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 7 TUBE, WITH APPLICATOR in 1 CARTON (49035-347-07) / 45 g in 1 TUBE, WITH APPLICATOR | May 1, 2020 |
| 55319-573-15 | 55319-573 | Family Dollar (FAMILY WELLNESS) | 1 TUBE, WITH APPLICATOR in 1 CARTON (55319-573-15) / 45 g in 1 TUBE, WITH APPLICATOR | July 1, 2023 |
| 37808-825-26 | 37808-825 | H E B | 1 TUBE, WITH APPLICATOR in 1 CARTON (37808-825-26) / 45 g in 1 TUBE, WITH APPLICATOR | January 9, 2006 |
| 61269-730-41 | 61269-730 | H2-Pharma, LLC | 1 TUBE, WITH APPLICATOR in 1 CARTON (61269-730-41) / 45 g in 1 TUBE, WITH APPLICATOR | April 12, 2021 |
| 61269-730-63 | 61269-730 | H2-Pharma, LLC | 1 TUBE, WITH APPLICATOR in 1 CARTON (61269-730-63) / 45 g in 1 TUBE, WITH APPLICATOR | March 15, 2021 |
| 42507-769-29 | 42507-769 | HyVee Inc | 1 TUBE in 1 CARTON (42507-769-29) / 45 g in 1 TUBE | April 20, 2026 |
| 30142-825-29 | 30142-825 | Kroger Company | 1 TUBE in 1 CARTON (30142-825-29) / 45 g in 1 TUBE | July 15, 2002 |
| 0904-7734-45 | 0904-7734 | Major Pharmaceuticals | 1 TUBE, WITH APPLICATOR in 1 CARTON (0904-7734-45) / 45 g in 1 TUBE, WITH APPLICATOR | April 21, 2009 |
| 41250-825-29 | 41250-825 | Meijer Distribution Inc | 1 TUBE in 1 CARTON (41250-825-29) / 45 g in 1 TUBE | February 4, 2000 |
| 68071-3544-7 | 68071-3544 | NuCare Pharmaceuticals,Inc. | 1 TUBE, WITH APPLICATOR in 1 CARTON (68071-3544-7) / 45 g in 1 TUBE, WITH APPLICATOR | December 8, 2023 |
| 59726-988-01 | 59726-988 | P & L Development, LLC | 1 TUBE, WITH APPLICATOR in 1 CARTON (59726-988-01) / 45 g in 1 TUBE, WITH APPLICATOR | May 28, 2021 |
| 68788-7917-4 | 68788-7917 | Preferred Pharmaceuticals Inc. | 1 TUBE, WITH APPLICATOR in 1 CARTON (68788-7917-4) / 45 g in 1 TUBE, WITH APPLICATOR | May 27, 2021 |
| 68788-8661-4 | 68788-8661 | Preferred Pharmaceuticals Inc. | 1 TUBE, WITH APPLICATOR in 1 CARTON (68788-8661-4) / 45 g in 1 TUBE, WITH APPLICATOR | May 13, 2024 |
| 63868-198-45 | 63868-198 | QUALITY CHOICE (Chain Drug Marketing Association) | 1 TUBE, WITH APPLICATOR in 1 CARTON (63868-198-45) / 45 g in 1 TUBE, WITH APPLICATOR | July 1, 2010 |
| 83324-160-15 | 83324-160 | QUALITY CHOICE (Chain Drug Marketing Association) | 1 TUBE in 1 CARTON (83324-160-15) / 45 g in 1 TUBE | July 31, 2024 |
| 21130-696-29 | 21130-696 | Safeway | 1 TUBE in 1 CARTON (21130-696-29) / 45 g in 1 TUBE | March 6, 2026 |
| 11673-049-06 | 11673-049 | TARGET Corporation | 1 TUBE, WITH APPLICATOR in 1 CARTON (11673-049-06) / 45 g in 1 TUBE, WITH APPLICATOR | November 25, 2019 |
| 0363-0730-41 | 0363-0730 | Walgreens | 1 TUBE, WITH APPLICATOR in 1 CARTON (0363-0730-41) / 45 g in 1 TUBE, WITH APPLICATOR | December 1, 2000 |
| 69842-988 | 69842-988 | CVS Pharmacy | — | January 13, 1997 |
| 70000-0009 | 70000-0009 | Cardinal Health (Leader) 70000 | — | July 1, 2019 |
| 49035-347 | 49035-347 | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | — | May 1, 2020 |
| 55319-573 | 55319-573 | Family Dollar (FAMILY WELLNESS) | — | July 1, 2023 |
| 37808-825 | 37808-825 | H E B | — | January 9, 2006 |
| 61269-730 | 61269-730 | H2-Pharma, LLC | — | April 12, 2021 |
| 42507-769 | 42507-769 | HyVee Inc | — | April 20, 2026 |
| 30142-825 | 30142-825 | Kroger Company | — | July 15, 2002 |
| 0904-7734 | 0904-7734 | Major Pharmaceuticals | — | April 21, 2009 |
| 41250-825 | 41250-825 | Meijer Distribution Inc | — | February 4, 2000 |
| 68071-3544 | 68071-3544 | NuCare Pharmaceuticals,Inc. | — | March 15, 2021 |
| 59726-988 | 59726-988 | P & L Development, LLC | — | May 28, 2021 |
| 68788-7917 | 68788-7917 | Preferred Pharmaceuticals Inc. | — | May 27, 2021 |
| 68788-8661 | 68788-8661 | Preferred Pharmaceuticals Inc. | — | April 21, 2009 |
| 63868-198 | 63868-198 | QUALITY CHOICE (Chain Drug Marketing Association) | — | July 1, 2010 |
| 83324-160 | 83324-160 | QUALITY CHOICE (Chain Drug Marketing Association) | — | July 31, 2024 |
| 21130-696 | 21130-696 | Safeway | — | March 6, 2026 |
| 11673-049 | 11673-049 | TARGET Corporation | — | January 13, 1997 |
| 0363-0730 | 0363-0730 | Walgreens | — | December 1, 2000 |
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 |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.