ORAVIG (miconazole) buccal tablets are applied topically to the gum once daily and release miconazole as the buccal tablet gradually dissolves [see Clinical Pharmacology (12.3)] . Miconazole is an imidazole antifungal agent and is described chemically as 1-[(2RS)-2-[(2,4-dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole with an empirical formula of C 18 H 14 Cl 4 N 2 O and a molecular weight of 416.13. The structural formula is shown in Figure 1. Figure 1: Structural Formula of Miconazole Miconazole drug substance is a white to almost white powder. ORAVIG contains 50 mg of miconazole base, USP and the following inactive ingredients: hypromellose, USP; milk protein concentrate; corn starch, NF; lactose monohydrate, NF; sodium lauryl sulfate, NF; magnesium stearate, NF; and talc, USP. oravig 01

Can you take miconazole with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run miconazole against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is miconazole sold under?

We track 10 miconazole-containing products in the U.S.: Monistat, Monistat 3, Monistat 3 Combination Pack, Monistat 3 Combination Pack (Prefilled), Monistat 7, Monistat 7 Combination Pack, Monistat 5 and Monistat Dual- Pak, and 2 more. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does miconazole come in?

Across the brands we track, miconazole is currently marketed as injectable, kit, suppository, topical, tampon and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic miconazole?

We do not currently list a generic-labelled miconazole product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Has miconazole been recalled?

The FDA's Enforcement database lists 2 recall records whose product description mentions miconazole. The most recent: DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.… (Aug 27, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

Miconazole: uses, dosing, side effects & brands

Miconazole is a medicine sold in the U.S. under 10 brand and generic names, for aspergillosis, cutaneous candidiasis and vulvovaginal candidiasis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesHow we research

Key facts

Treats: Aspergillosis, Cutaneous Candidiasis and Vulvovaginal Candidiasis
Available as: Injectable · Kit · Suppository · Topical · Tampon · Tablet
Sold as: 10 products — Monistat, Monistat 3 and Monistat 3 Combination Pack, and others
Prescription?: Both Rx and OTC forms
Generic available?: Not in our catalog
Typical price: about $0 for a 30-count supply

How miconazole is dosed

From the FDA label for Oravig (application NDA022404). Other miconazole products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Application of one ORAVIG 50 mg buccal tablet to the gum region once daily for 14 consecutive days (2.1) . Instruct patients not to crush, chew, or swallow tablets (2.2) . 2.1 Basic Dosing Information The recommended dosing schedule for ORAVIG is the application of one 50 mg buccal tablet to the upper gum region (canine fossa) once daily for 14 consecutive days. 2.2 Administration Instructions ORAVIG should be applied in the morning, after brushing the teeth. The tablet should be applied with dry hands. The rounded side surface of the tablet should be placed against the upper gum just above the incisor tooth (canine fossa) and held in place with slight pressure over the upper lip for 30 seconds to ensure adhesion. The tablet is round on one side for comfort, but either side of the tablet can be applied to the gum. Once applied, ORAVIG stays in position and gradually dissolves. [ See Clinical Pharmacology (12.3) ] Subsequent applications of ORAVIG should be made to alternate sides of the mouth. Before applying the next tablet, the patient should clear away any remaining tablet material. In addition, ORAVIG should not be crushed, chewed or swallowed. Food and drink can be taken normally when ORAVIG is in place but chewing gum should be avoided. If ORAVIG does not adhere or falls off within the first 6 hours, the same tablet should be repositioned immediately. If the tablet still…

Miconazole side effects

The following serious adverse drug reactions are discussed in detail in other sections of labeling: Hypersensitivity reactions [see Warnings and Precautions (5.1)] Most common adverse reactions (≥2%) are: diarrhea, headache, nausea, dysgeusia, upper abdominal pain, and vomiting (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Galt Pharmaceuticals, LLC Marietta, GA 30067 at 1-833-757-0904 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The overall safety of ORAVIG was assessed in 480 adult subjects: 315 HIV-infected subjects, 147 subjects with head and neck cancer, and 18 healthy subjects. HIV Infected Patients Two trials were conducted in immunocompromised HIV-infected patients: one randomized, double-blind, double-dummy, active-controlled design (N = 290 ORAVIG, 287 control) and one non-comparative trial (N = 25). In the randomized, double blind trial (Study 1), 290 HIV infected subjects used ORAVIG once daily for 14 days, and 287 subjects used 10 mg clotrimazole troches five times daily for 14 days. Adverse reactions occurring in ≥ 2% of patients in either treatment are…

Every miconazole product we track (10)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Miconazole products
#	Drug	Rating	Type	Form	Generic?	Typical price
1	Monistat	72/100	Prescription	Injectable	Generic	$0	View →
2	Monistat 3	70/100	Over-the-counter	Kit	—	—

Combination products containing miconazole

A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.

Vusion

Miconazole recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

Frequently asked questions

What is miconazole?: ORAVIG (miconazole) buccal tablets are applied topically to the gum once daily and release miconazole as the buccal tablet gradually dissolves [see Clinical Pharmacology (12.3)] . Miconazole is an imidazole antifungal agent and is described chemically as 1-[(2RS)-2-[(2,4-dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole with an empirical formula of C 18 H 14 Cl 4 N 2 O and a molecular weight of 416.13. The structural formula is shown in Figure 1. Figure 1: Structural Formula of Miconazole Miconazole drug substance is a white to almost white powder. ORAVIG contains 50 mg of miconazole base, USP and the following inactive ingredients: hypromellose, USP; milk protein concentrate; corn starch, NF; lactose monohydrate, NF; sodium lauryl sulfate, NF; magnesium stearate, NF; and talc, USP. oravig 01
Can you take miconazole with other medicines?: It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run miconazole against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is miconazole sold under?: We track 10 miconazole-containing products in the U.S.: Monistat, Monistat 3, Monistat 3 Combination Pack, Monistat 3 Combination Pack (Prefilled), Monistat 7, Monistat 7 Combination Pack, Monistat 5 and Monistat Dual- Pak, and 2 more. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does miconazole come in?: Across the brands we track, miconazole is currently marketed as injectable, kit, suppository, topical, tampon and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic miconazole?: We do not currently list a generic-labelled miconazole product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.