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Miconazole 7

Miconazole Nitrate · Cream

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Miconazole 7
Generic name
Miconazole Nitrate
Dosage form
Cream
Route
Vaginal
Marketing category
ANDA · ANDA
Labeler
H2-Pharma, LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
4
NDC product codes
19
Packages
20
Data completeness
82% 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 100 mg/g 992765 View
Miconazole Nitrate 2 g/100g 992765 View
Miconazole Nitrate 20 mg/100g 992765 View
Miconazole Nitrate 20 mg/g 992765 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Cream
Route of administration
Vaginal
Presentations
39

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@FDANDC Directory
Application number
074164
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 29, 1996
Sponsor
ENCUBE
Products on application
1
Submissions recorded
14
Products approved under application 074164.
Product Trade name Form Strength Ingredient Status TE Flags
074164-001 MICONAZOLE 7 CREAM MICONAZOLE NITRATE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 074164.
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 Labeling

Reproduced 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.

HUMAN OTC DRUG · 20260820 HUMAN OTC DRUG · 20260708 HUMAN OTC DRUG · 20260708 HUMAN OTC DRUG · 20260526

Indications and Usage

openFDA Drug Labeling

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

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 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 i f 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 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 ingredients Miconazole nitrate, USP 2% (100 mg in each applicator)

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
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

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.