Monistat 7 — Cream

Overview

Brand name

Monistat 7 with Reusable Applicator

Generic name

Miconazole Nitrate

Dosage form

Cream

Route

Vaginal

Marketing category

NDA · NDA

Labeler

Insight Pharmaceuticals LLC

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	20 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@FDA NDC Directory

Application number

017450

Application type

NDA · New Drug Application

Approval date

January 30, 1974

Sponsor

MEDTECH PRODUCTS

Products on application

1

Submissions recorded

54

Products approved under application 017450.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
017450-002	MONISTAT 7	CREAM		MICONAZOLE NITRATE	Over-the-counter	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes 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

Most recent submissions on application 017450.
Type	No.	Action	Status	Date	Review
Supplement	75	Manufacturing (CMC)	Approved	July 22, 2020	N/A
Supplement	73	Labeling	Approved	January 28, 2020	Standard
Supplement	68	Manufacturing (CMC)	Approved	August 10, 2015	Priority
Supplement	67	Manufacturing (CMC)	Approved	March 10, 2014	Priority
Supplement	66	Manufacturing (CMC)	Approved	February 27, 2014	Priority
Supplement	64	Manufacturing (CMC)	Approved	August 13, 2013	Priority
Supplement	63	Manufacturing (CMC)	Approved	July 10, 2013	Priority
Supplement	62	Manufacturing (CMC)	Approved	January 29, 2013	Priority
Supplement	56	Manufacturing (CMC)	Approved	November 5, 2009	N/A
Supplement	55	Manufacturing (CMC)	Approved	August 21, 2008	Priority
Supplement	51	Manufacturing (CMC)	Approved	October 28, 2002	Priority
Supplement	52	Manufacturing (CMC)	Approved	August 7, 2002	Priority
Supplement	50	Manufacturing (CMC)	Approved	April 10, 2002	Priority
Supplement	49	Manufacturing (CMC)	Approved	May 16, 2001	Priority
Supplement	47	Manufacturing (CMC)	Approved	October 4, 1999	Priority
Supplement	46	Manufacturing (CMC)	Approved	February 4, 1999	Priority
Supplement	45	Manufacturing (CMC)	Approved	February 3, 1999	Priority
Supplement	44	Manufacturing (CMC)	Approved	March 17, 1998	Priority
Supplement	43	Manufacturing (CMC)	Approved	March 21, 1997	Priority
Supplement	42	Manufacturing (CMC)	Approved	March 6, 1995	Priority
Supplement	40	Labeling	Approved	February 9, 1995	Standard
Supplement	41	Manufacturing (CMC)	Approved	September 3, 1993	Priority
Supplement	38	Efficacy	Approved	April 26, 1993	—
Supplement	39	Labeling	Approved	October 8, 1992	Standard
Supplement	37	Labeling	Approved	June 3, 1992	—
Supplement	35	Efficacy	Approved	February 15, 1991	—
Supplement	34	Manufacturing (CMC)	Approved	March 9, 1990	Priority
Supplement	32	Manufacturing (CMC)	Approved	August 26, 1986	Priority
Supplement	31	Manufacturing (CMC)	Approved	July 22, 1986	Priority
Supplement	30	Manufacturing (CMC)	Approved	July 22, 1986	Priority
Supplement	29	Manufacturing (CMC)	Approved	July 5, 1985	Priority
Supplement	28	Manufacturing (CMC)	Approved	June 27, 1985	Priority
Supplement	27	Manufacturing (CMC)	Approved	June 12, 1984	Priority
Supplement	26	Manufacturing (CMC)	Approved	May 29, 1984	Priority
Supplement	25	Manufacturing (CMC)	Approved	June 2, 1983	Priority
Supplement	24	Labeling	Approved	September 17, 1982	—
Supplement	20	Labeling	Approved	September 17, 1982	—
Supplement	22	Labeling	Approved	September 15, 1982	—
Supplement	23	Manufacturing (CMC)	Approved	May 13, 1982	Priority
Supplement	21	Manufacturing (CMC)	Approved	April 19, 1982	Priority
Supplement	16	Manufacturing (CMC)	Approved	April 3, 1980	Priority
Supplement	12	Manufacturing (CMC)	Approved	September 13, 1979	Priority
Supplement	15	Manufacturing (CMC)	Approved	June 29, 1979	Priority
Supplement	14	Manufacturing (CMC)	Approved	June 14, 1979	Priority
Supplement	13	Manufacturing (CMC)	Approved	June 14, 1979	Priority
Supplement	10	Manufacturing (CMC)	Approved	March 23, 1979	Priority
Supplement	11	Labeling	Approved	September 12, 1978	—
Supplement	9	Manufacturing (CMC)	Approved	April 25, 1978	Priority
Supplement	7	Manufacturing (CMC)	Approved	December 22, 1977	Priority
Supplement	6	Manufacturing (CMC)	Approved	August 2, 1977	Priority
Supplement	5	Manufacturing (CMC)	Approved	August 2, 1977	Priority
Supplement	3	Manufacturing (CMC)	Approved	July 28, 1977	Priority
Supplement	2	Manufacturing (CMC)	Approved	April 21, 1976	Priority
Original application	1	Type 1 - New Molecular Entity	Approved	January 30, 1974	Standard

Review documents

0 · Supplement · March 17, 2022
0 · Supplement · March 4, 2022
0 · Supplement · January 29, 2020
0 · Supplement · January 29, 2020
0 · Supplement · October 23, 2017
0 · Supplement · August 22, 2017
0 · Supplement · August 22, 2008
0 · Supplement · August 7, 2002
0 · Supplement · August 7, 2002

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251027). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251027 HUMAN OTC DRUG · 20241112

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purpose Miconazole nitrate 2% ...........................................................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: ○ applicator s : 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 Labeling

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.

Do Not Use

openFDA Drug Labeling

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

openFDA Drug Labeling

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, committing, or foul-smelling vaginal discharge.

Active Ingredient

openFDA Drug Labeling

Active ingredients Miconazole nitrate 2%

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
63736-025-15	63736-025	Insight Pharmaceuticals LLC	1 TUBE, WITH APPLICATOR in 1 CARTON (63736-025-15) / 45 g in 1 TUBE, WITH APPLICATOR	April 26, 1993
63736-026-15	63736-026	Insight Pharmaceuticals LLC	7 TUBE, WITH APPLICATOR in 1 CARTON (63736-026-15) / 45 g in 1 TUBE, WITH APPLICATOR	April 26, 1993
63736-025	63736-025	Insight Pharmaceuticals LLC	—	April 26, 1993
63736-026	63736-026	Insight Pharmaceuticals LLC	—	April 26, 1993

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.