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foster and thrive 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
foster and thrive miconazole 3
Generic name
Miconazole nitrate
Dosage form
Kit
Route
—
Marketing category
ANDA · ANDA
Labeler
Strategic Sourcing Services LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
2
Packages
2
Data completeness
76% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
—
Presentations
4

Regulatory status

Source: Drugs@FDANDC Directory
Application number
076357
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 30, 2004
Sponsor
PERRIGO
Products on application
1
Submissions recorded
3
Products approved under application 076357.
Product Trade name Form Strength Ingredient Status TE Flags
076357-001 MICONAZOLE 3 COMBINATION PACK CREAM MICONAZOLE NITRATE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 076357.
Type No. Action Status Date Review
Supplement 30 Labeling Approved August 21, 2017 Standard
Supplement 5 Labeling Approved April 12, 2005 —
Original application 1 Approved March 30, 2004 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251216). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251216 HUMAN OTC DRUG · 20250812

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 3 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 ingredient Miconazole nitrate (200 mg in each suppository) 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
70677-1223-1 70677-1223 Strategic Sourcing Services LLC 1 KIT in 1 CARTON (70677-1223-1) * 1 APPLICATOR in 1 POUCH (0113-7198-00) / 5 g in 1 APPLICATOR * 1 TUBE in 1 CARTON (0113-8123-00) / 9 g in 1 TUBE October 23, 2023
70677-1226-1 70677-1226 Strategic Sourcing Services LLC 1 KIT in 1 CARTON (70677-1226-1) * 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 October 19, 2023
70677-1223 70677-1223 Strategic Sourcing Services LLC — October 19, 2023
70677-1226 70677-1226 Strategic Sourcing Services LLC — October 19, 2023

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 · 7 sections on this page.