On this page
Monistat 3 Combination Pack
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 |
|---|---|---|---|---|---|---|---|
| 020670-002 | MONISTAT 3 COMBINATION PACK | CREAM, SUPPOSITORY | MICONAZOLE NITRATE | Over-the-counter | — | RLD RS |
Therapeutic equivalence
Source: Orange BookCodes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 41 | Labeling | Approved | November 17, 2023 | Standard |
| Supplement | 36 | Manufacturing (CMC) | Approved | July 22, 2020 | N/A |
| Supplement | 35 | Labeling | Approved | January 28, 2020 | Standard |
| Supplement | 29 | Manufacturing (CMC) | Approved | January 21, 2016 | Standard |
| Supplement | 28 | Manufacturing (CMC) | Approved | November 20, 2015 | Standard |
| Supplement | 24 | Manufacturing (CMC) | Approved | February 11, 2014 | Standard |
| Supplement | 22 | Manufacturing (CMC) | Approved | July 10, 2013 | Standard |
| Supplement | 21 | Manufacturing (CMC) | Approved | February 6, 2013 | Standard |
| Supplement | 14 | Manufacturing (CMC) | Approved | March 16, 2007 | N/A |
| Supplement | 11 | Labeling | Approved | January 9, 2003 | Standard |
| Supplement | 10 | Manufacturing (CMC) | Approved | October 28, 2002 | Standard |
| Supplement | 9 | Manufacturing (CMC) | Approved | April 10, 2002 | Standard |
| Supplement | 7 | Manufacturing (CMC) | Approved | January 20, 2000 | Standard |
| Supplement | 5 | Manufacturing (CMC) | Approved | October 4, 1999 | Standard |
| Supplement | 4 | Manufacturing (CMC) | Approved | March 26, 1999 | Standard |
| Supplement | 3 | Manufacturing (CMC) | Approved | March 17, 1998 | Standard |
| Supplement | 2 | Manufacturing (CMC) | Approved | March 21, 1997 | Standard |
| Supplement | 1 | Manufacturing (CMC) | Approved | August 15, 1996 | Standard |
| Original application | 1 | Type 8 - Partial Rx to OTC Switch | Approved | April 16, 1996 | Standard |
Review documents
- 0 · Supplement · November 24, 2023
- 0 · Supplement · November 20, 2023
- 0 · Supplement · March 17, 2022
- 0 · Supplement · March 4, 2022
- 0 · Supplement · January 29, 2020
- 0 · Supplement · January 29, 2020
- 0 · Supplement · July 2, 2014
- 0 · Supplement · November 9, 2012
- 0 · Supplement · March 23, 2007
- 0 · Supplement · March 23, 2007
- 0 · Supplement · January 9, 2003
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260420). 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 a disposable applicator, place the insert into the vagina at bedtime for three nights in a row. Throw applicator away after use. ▪ 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 p harmacist 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, v omiting, 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.
Do Not Use
openFDA Drug LabelingDo 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
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, v omiting, or foul-smelling vaginal discharge
Active Ingredient
openFDA Drug LabelingA ctive i ngredient s Miconazole nitrate (200 mg in each vaginal insert) Miconazole nitrate 2% (external cream)
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 63736-010-01 | 63736-010 | Insight Pharmaceuticals LLC | 1 KIT in 1 PACKAGE, COMBINATION (63736-010-01) * 5 g in 1 APPLICATOR * 9 g in 1 TUBE | December 10, 2009 |
| 63736-019-03 | 63736-019 | Insight Pharmaceuticals LLC | 1 KIT in 1 PACKAGE, COMBINATION (63736-019-03) * 3 SUPPOSITORY in 1 KIT * 9 g in 1 TUBE | April 16, 1996 |
| 63736-010 | 63736-010 | Insight Pharmaceuticals LLC | — | December 10, 2009 |
| 63736-019 | 63736-019 | Insight Pharmaceuticals LLC | — | April 16, 1996 |
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 · 8 sections on this page.