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Miconazole 3

Miconazole nitrate · Kit

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.

Overview

Brand name
Miconazole 3
Generic name
Miconazole nitrate
Dosage form
Kit
Route
—
Marketing category
ANDA · ANDA
Labeler
Rite Aid Corporation
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
10
Packages
10
Data completeness
82% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
—
Presentations
20

Regulatory status

Source: Drugs@FDANDC Directory
Application number
075329
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 20, 1999
Sponsor
L PERRIGO CO
Products on application
1
Submissions recorded
8
Products approved under application 075329.
Product Trade name Form Strength Ingredient Status TE Flags
075329-001 MICONAZOLE NITRATE COMBINATION PACK CREAM, SUPPOSITORY MICONAZOLE NITRATE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 075329.
Type No. Action Status Date Review
Supplement 50 Labeling Approved May 29, 2024 Standard
Supplement 44 Labeling Approved May 29, 2024 Standard
Supplement 40 Labeling Approved August 21, 2017 Standard
Supplement 15 Labeling Approved April 8, 2005 —
Supplement 9 Labeling Approved May 20, 2003 —
Supplement 2 Labeling Approved January 29, 2002 —
Supplement 1 Labeling Approved January 29, 2002 —
Original application 1 Approved April 20, 1999 —

Review documents

  • 0 · Original application · June 9, 2004
  • 0 · Original application · December 18, 2001
  • 0 · Original application · April 20, 1999

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260721). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260721 HUMAN OTC DRUG · 20231108

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 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: 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 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 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 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 (200 mg in each vaginal insert) Miconazole nitrate 2% (external cream)

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
59779-839-00 59779-839 CVS Pharmacy 1 KIT in 1 CARTON (59779-839-00) * 1 APPLICATOR in 1 POUCH / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON / 9 g in 1 TUBE February 28, 2014
51316-689-00 51316-689 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 1 KIT in 1 CARTON (51316-689-00) * 3 BLISTER PACK in 1 KIT (0113-6650-00) / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT (0113-8123-00) / 9 g in 1 TUBE April 17, 2024
37808-242-00 37808-242 H E B 1 KIT in 1 CARTON (37808-242-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE March 14, 2006
30142-081-00 30142-081 Kroger Company 1 KIT in 1 CARTON (30142-081-00) * 3 BLISTER PACK in 1 KIT (0113-6650-00) / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 CARTON (0113-8123-00) / 9 g in 1 TUBE February 23, 2000
41250-081-00 41250-081 Meijer Distribution Inc 1 KIT in 1 CARTON (41250-081-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE February 4, 2000
41250-982-00 41250-982 Meijer Distribution Inc 1 KIT in 1 CARTON (41250-982-00) * 1 APPLICATOR in 1 POUCH / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON / 9 g in 1 TUBE October 12, 2016
11822-0209-0 11822-0209 Rite Aid Corporation 1 KIT in 1 CARTON (11822-0209-0) * 3 BLISTER PACK in 1 KIT (0113-6650-00) / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT (0113-8123-00) / 9 g in 1 TUBE November 9, 2023
11822-0800-0 11822-0800 Rite Aid Corporation 1 KIT in 1 CARTON (11822-0800-0) * 1 APPLICATOR in 1 POUCH / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON / 9 g in 1 TUBE February 12, 2014
21130-759-00 21130-759 Safeway 1 KIT in 1 CARTON (21130-759-00) * 3 BLISTER PACK in 1 KIT (0113-6650-00) / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT (0113-8123-00) / 9 g in 1 TUBE May 9, 2025
0363-5203-01 0363-5203 WALGREEN COMPANY 1 KIT in 1 PACKAGE, COMBINATION (0363-5203-01) * 1 APPLICATOR in 1 PACKAGE / 1 SUPPOSITORY in 1 APPLICATOR * 9 g in 1 TUBE April 18, 2016
59779-839 59779-839 CVS Pharmacy — February 28, 2014
51316-689 51316-689 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED — April 17, 2024
37808-242 37808-242 H E B — March 14, 2006
30142-081 30142-081 Kroger Company — February 23, 2000
41250-081 41250-081 Meijer Distribution Inc — February 4, 2000
41250-982 41250-982 Meijer Distribution Inc — October 12, 2016
11822-0209 11822-0209 Rite Aid Corporation — November 9, 2023
11822-0800 11822-0800 Rite Aid Corporation — February 12, 2014
21130-759 21130-759 Safeway — May 9, 2025
0363-5203 0363-5203 WALGREEN COMPANY — April 18, 2016

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

Generated September 25, 2026 · 8 sections on this page.