good sense miconazole 7 — Cream

Overview

Brand name

good sense miconazole 7

Generic name

Miconazole nitrate

Dosage form

Cream

Route

Vaginal

Marketing category

ANDA · ANDA

Labeler

L Perrigo Company

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

3

Packages

3

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	2 g/100g	992765	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Cream

Route of administration

Vaginal

Presentations

6

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

074760

Application type

ANDA · Abbreviated New Drug Application

Approval date

May 15, 1997

Sponsor

PERRIGO

Products on application

1

Submissions recorded

8

Products approved under application 074760.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
074760-001	MICONAZOLE NITRATE	CREAM		MICONAZOLE NITRATE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 074760.
Type	No.	Action	Status	Date	Review
Supplement	37	Labeling	Approved	August 21, 2017	Standard
Supplement	15	Labeling	Approved	April 14, 2005	—
Supplement	9	Labeling	Approved	August 17, 2004	—
Supplement	5	Labeling	Approved	January 30, 2002	—
Supplement	4	Labeling	Approved	January 30, 2002	—
Supplement	3	Manufacturing (CMC)	Approved	June 8, 1999	—
Supplement	2	Manufacturing (CMC)	Approved	September 25, 1998	—
Original application	1		Approved	May 15, 1997	—

Review documents

0 · Original application · July 22, 2005

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260608). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260608 HUMAN OTC DRUG · 20210127

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 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: • 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 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 (1-800-222-1222).

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, vomiting, or foul-smelling vaginal discharge

Active Ingredient

openFDA Drug Labeling

Active ingredient 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
0113-0214-29	0113-0214	L Perrigo Company	1 TUBE, WITH APPLICATOR in 1 CARTON (0113-0214-29) / 45 g in 1 TUBE, WITH APPLICATOR	July 30, 1999
0113-0825-29	0113-0825	L. Perrigo Company	1 TUBE in 1 CARTON (0113-0825-29) / 45 g in 1 TUBE	February 22, 2000
68788-4117-4	68788-4117	Preferred Pharmaceuticals Inc.	1 TUBE in 1 CARTON (68788-4117-4) / 45 g in 1 TUBE	June 8, 2026
0113-0214	0113-0214	L Perrigo Company	—	July 30, 1999
0113-0825	0113-0825	L. Perrigo Company	—	February 22, 2000
68788-4117	68788-4117	Preferred Pharmaceuticals Inc.	—	June 8, 2026

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 · 10 sections on this page.