Miconazole 7 Miconazole Nitrate 20 mg/g Cream
by QUALITY CHOICE (Chain Drug Marketing Association) · 1 TUBE, WITH APPLICATOR in 1 CARTON (63868-198-45) / 45 g in 1 TUBE, WITH APPLICATOR
NDC 63868-0198-45
🏷️ FDA NDC (as labeled)
63868-198-45
billing pads the product segment with a zero
OTC
Generic
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Miconazole Nitrate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 10, 2024 — Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0315-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
🆔 Identity & classification
FDA NDC (as labeled)
63868-198-45
Product NDC
63868-198
11-digit billing NDC
63868019845
NCPDP billing unit
GM — per gram (weight)
RxCUI
998540
UNII
VW4H1CYW1K
UPC
0635515999107
Application #
ANDA074164
SPL Set ID
68667d2e-d4d0-46e7-9d84-0f23fdac1cf7
Established class (EPC)
Azole Antifungal
Chemical class
Azoles
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2010-07-01
Route
VAGINAL
Dosage form
CREAM
Substance
MICONAZOLE NITRATE
GPI-14
55104050103710
GPI class
QC Miconazole 7
GCN Seq No
007003
GCN
28380
HICL code
003031
Ingredient (HICL)
Miconazole Nitrate
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q4
Therapeutic class — intermediate (HIC2)
Vaginal Preparations
HIC3 code
Q4F
Therapeutic class — specific (HIC3)
Vaginal Antifungals
AHFS code
84:04.08.08
AHFS class
Azoles (Skin And Mucous Membrane)
FDB label name
QC MICONAZOLE-7 CREAM
FDB brand name
Miconazole-7
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 63868-198-45 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63868-0198-45. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.
🏷️ RxNorm drug class
This medicine belongs to the Azole Antifungal class.
Pharmacologic class
Azole Antifungal
Drug family (ATC)
Antiinfectives and antiseptics for local oral treatment, Imidazole derivatives, Imidazole and triazole derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerQUALITY CHOICE (Chain Drug Marketing Association)
Application holderENCUBE ETHICALS PRIVATE LTD
FDA applicationANDA074164 (ANDA)
Labeler code63868
First marketedJul 2010
Product typeHuman Otc Drug
Portfolio91 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
Label name QC MICONAZOLE-7 CREAM Ingredient Miconazole Nitrate
📖 What it is MedlinePlus · NLM
Vaginal miconazole is used to treat vaginal yeast infections in adults and children 12 years of age and older. Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- For a 7-night vaginal cream, you insert one full applicator into your vagina at bedtime for 7 nights in a row. If you have itching or irritation on the outside, squeeze a small amo...
- I bought a miconazole cream for a vaginal yeast infection — how do I use it correctly?
- Yes — topical miconazole creams and powders are specifically made for those conditions. For athlete's foot and ringworm, you'd apply it to clean, dry skin twice a day for 4 weeks....
- Can I use miconazole cream on my skin for athlete's foot or jock itch?
Patient education
Supplement & herbal interactions
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.
💬 Questions about Miconazole Nitrate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII DRG3KJZ1TJ
A plant-derived oil combined with polyethylene glycol to create a solubilizer. It helps dissolve or evenly distribute medicines in liquid formulations and improves how the body absorbs certain active ingredients.
-
UNII 8SKN0B0MIM
Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
-
UNII REK4960K2U
Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
-
UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
-
UNII 3EW5AXE5X5
A synthetic surfactant derived from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and improves how the medicine dissolves and is absorbed in the body.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesbenzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.130 | $5.87 / 45 g |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per g) — tap or hover for the price & month
▲ Up 2% over the last 12 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Good Sense Miconazole 7 2 g/100g 00113-0214-29 | L | 1 tube | $0.122 | — | Availability likely | save 7% |
| good sense miconazole 7 2 g/100g 00113-0825-29 | L. | 1 tube | $0.122 | — | Availability likely | save 7% |
| Miconazole 7 20 mg/g 00904-7734-45 | Major | 1 tube | $0.122 | — | Availability likely | save 7% |
| Good Neighbor Pharmacy Miconazole 7 2 g/100g 24385-0590-29 | Amerisource | 1 tube | $0.122 | — | Availability likely | save 7% |
| Miconazole Nitrate 20 mg/g 51672-2035-06 | Sun | 1 tube | $0.122 | — | Availability likely | save 7% |
| Miconazole 7 20 mg/g 61269-0730-41 | H2-Pharma, | 1 tube | $0.122 | — | Availability likely | save 7% |
| Miconazole 7 20 mg/g 70000-0009-01 | Cardinal | 1 tube | $0.122 | — | Availability likely | save 7% |
| foster and thrive miconazole 2 g/100g 70677-1222-01 | Strategic | 1 tube | $0.122 | — | Availability likely | save 7% |
| foster and thrive miconazole 7 2 g/100g 70677-1225-01 | Strategic | 1 tube | $0.122 | — | Availability likely | save 7% |
| Miconazole 7 20 mg/g 83324-0160-15 | QUALITY | 1 tube | $0.122 | — | Availability likely | save 7% |
| Miconazole 7 20 mg/gthis 63868-0198-45 | QUALITY | 1 tube | $0.130 | — | FDA listed | — |
| Miconazole 7 20 mg/g 00363-0730-41 | Walgreens | 1 tube | — | — | FDA listed | — |
| vagisil brand vagistat 2 g/100g 11509-0825-01 | Combe | 1 tube | — | — | FDA listed | — |
| Miconazole 7 20 mg/g 11673-0049-06 | TARGET | 1 tube | — | — | FDA listed | — |
| up and up miconazole 7 2 g/100g 11673-0825-29 | Target | 1 tube | — | — | FDA listed | — |
| Miconazole 7 2 g/100g 21130-0696-29 | Safeway | 1 tube | — | — | FDA listed | — |
| signature care miconazole 7 2 g/100g 21130-0825-29 | Safeway | 1 tube | — | — | FDA listed | — |
| Miconazole 7 2 g/100g 30142-0825-29 | Kroger | 1 tube | — | — | FDA listed | — |
| Topcare Miconazole 7 2 g/100g 36800-0825-29 | Topco | 1 tube | — | — | FDA listed | — |
| miconazole 7 2 g/100g 37808-0825-29 | H | 1 tube | — | — | FDA listed | — |
| Equaline Miconazole 7 2 g/100g 41163-0825-29 | United | 1 tube | — | — | FDA listed | — |
| Miconazole 7 2 g/100g 41250-0825-29 | Meijer | 1 tube | — | — | FDA listed | — |
| Careone miconazole 7 2 g/100g 41520-0825-29 | American | 1 tube | — | — | FDA listed | — |
| miconazole 7 2 g/100g 42507-0769-29 | HyVee | 1 tube | — | — | FDA listed | — |
| Miconazole 7 100 mg/g 49035-0347-07 | EQUATE | 7 tubes | — | — | FDA listed | — |
| Miconazole Nitrate 20 mg/g 50090-4356-00 | A-S | 1 tube | — | — | FDA listed | — |
| Miconazole 7 20 mg/g 55319-0573-15 | Family | 1 tube | — | — | FDA listed | — |
| DG Health Miconazole 2 g/100g 55910-0698-29 | Dolgencorp | 1 tube | — | — | FDA listed | — |
| Miconazole 7 20 mg/g 59726-0988-01 | P | 1 tube | — | — | FDA listed | — |
| Monistat 7 with Reusable Applicator 20 mg/g 63736-0025-15 | Insight | 1 tube | — | — | FDA listed | — |
| Monistat 7 7-Day Disposable Applicators 20 mg/g 63736-0026-15 | Insight | 7 tubes | — | — | FDA listed | — |
| Miconazole 7 20 mg/g 68071-3544-07 | NuCare | 1 tube | — | — | FDA listed | — |
| good sense miconazole 7 2 g/100g 68788-4117-04 | Preferred | 1 tube | — | — | FDA listed | — |
| Miconazole 7 20 mg/g 68788-7917-04 | Preferred | 1 tube | — | — | FDA listed | — |
| Miconazole 7 20 mg/g 68788-8661-04 | Preferred | 1 tube | — | — | FDA listed | — |
| Vagisten-V 7 Day 2 g/100g 69729-0612-05 | OPMX | 1 tube | — | — | FDA listed | — |
| Basic Care Miconazole 7 2 g/100g 72288-0825-29 | Amazon.com | 1 tube | — | — | FDA listed | — |
| Dr. Rainer s Vaginal Cream 2 g/100mL 73736-0115-05 | Plexoris | 1 tube | — | — | FDA listed | — |
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.
⏳ Availability & generic status
🏛️
2010
On the market since
Jul 2010
📍
2026
Currently FDA-listed
16 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Miconazole 3 (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Miconazole 3. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$35.6K
Claims incl. refills
725
Beneficiaries
649
Spend / beneficiary
$54.91
Spend / claim
$49.15
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
🔬 Reported adverse events (FAERS)
Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Miconazole 7 (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 12%
Female · 88%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63868-0198-45 You're viewing this | 1 TUBE, WITH APPLICATOR in 1 CARTON (63868-198-45) / 45 g in 1 TUBE, WITH APPLICATOR | 2010-07-01 | Active |
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
⏱️ Dosage and Administration ▾
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: • applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator 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 to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed. children under 12 years of age: ask a doctor
⚠️ Warnings ▾
Warnings F o r vaginal use only Do not use i f 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.
🧪 Active Ingredient ▾
Active ingredient Miconazole nitrate, USP 2% (100 mg in each applicator)
🧪 Inactive Ingredients ▾
Inactive ingredients benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
🎯 Purpose ▾
Purpose Vaginal antifungal
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published
NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.