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tioconazole 1

Tioconazole · Ointment

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
tioconazole 1
Generic name
Tioconazole
Dosage form
Ointment
Route
Vaginal
Marketing category
ANDA · ANDA
Labeler
Meijer Distribution Inc
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
6
Packages
6
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
Tioconazole 6.5 g/100g 198380 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Ointment
Route of administration
Vaginal
Presentations
12

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
075915
Application type
ANDA · Abbreviated New Drug Application
Approval date
November 21, 2001
Sponsor
PERRIGO
Products on application
1
Submissions recorded
5
Products approved under application 075915.
Product Trade name Form Strength Ingredient Status TE Flags
075915-001 TIOCONAZOLE OINTMENT TIOCONAZOLE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 075915.
Type No. Action Status Date Review
Supplement 25 Labeling Approved November 17, 2015 Standard
Supplement 15 Labeling Approved April 30, 2007 —
Supplement 6 Labeling Approved October 10, 2003 —
Supplement 2 Manufacturing (CMC) Approved December 9, 2002 —
Original application 1 Approved November 21, 2001 —

Review documents

  • 0 · Original application · July 22, 2005
  • 0 · Original application · April 16, 2003

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260404). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260404

Indications and Usage

openFDA Drug Labeling

Use • treats vaginal yeast infections

Purpose Vaginal antifungal

Dosage and Administration

openFDA Drug Labeling

Directions • before using this product, read the enclosed brochure and instructions on printed packet for complete directions and information • adults and children 12 years of age and over: • open the printed packet just before use and remove purple cap • insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use. • 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 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 disease (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 after 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 after 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 (in each applicator) Tioconazole 300 mg (6.5%)

Adverse event reports

Source: openFDA FAERS
1,541
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: TIOCONAZOLE. 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
72288-222-54 72288-222 Amazon.com Services LLC 1 POUCH in 1 CARTON (72288-222-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR June 18, 2026
59779-718-26 59779-718 CVS Pharmacy 1 POUCH in 1 CARTON (59779-718-26) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR November 12, 2015
37808-426-54 37808-426 H E B 1 POUCH in 1 CARTON (37808-426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR May 9, 2016
41250-426-54 41250-426 Meijer Distribution Inc 1 POUCH in 1 CARTON (41250-426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR January 9, 2008
21130-781-54 21130-781 Safeway 1 POUCH in 1 CARTON (21130-781-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR May 1, 2026
0363-0426-54 0363-0426 Walgreen Company 1 POUCH in 1 CARTON (0363-0426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR December 19, 2007
72288-222 72288-222 Amazon.com Services LLC — June 18, 2026
59779-718 59779-718 CVS Pharmacy — November 12, 2015
37808-426 37808-426 H E B — May 9, 2016
41250-426 41250-426 Meijer Distribution Inc — January 9, 2008
21130-781 21130-781 Safeway — May 1, 2026
0363-0426 0363-0426 Walgreen Company — December 19, 2007

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.