Home › NDC Lookup › Ingredients › Miconazole Nitrate › 63868-0198-45
Miconazole 7 Miconazole Nitrate 20 mg/g Cream — NDC 63868-0198-45 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Miconazole 7 Miconazole Nitrate 20 mg/g Cream — NDC 63868-198-45 (Billing 63868-0198-45)

by QUALITY CHOICE (Chain Drug Marketing Association) · 1 TUBE, WITH APPLICATOR in 1 CARTON / 45 g in 1 TUBE, WITH APPLICATOR

This is a package of Miconazole 7 Miconazole Nitrate 20 mg/g Cream from QUALITY CHOICE (Chain Drug Marketing Association), marketed since Jul 2010 and currently FDA-listed; retail pharmacies pay about $0.1304 per g (NADAC). It is this product's only package size.

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 ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 63868-198-45 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63868 labeler · 198 product · 45 package
Package marketed since
Jul 1, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0635515999107
FDA record last changed
Oct 8, 2026
⚠️
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

Regulatory identifiers FDA, NLM and CMS codes for this package

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

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

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
Quick answers
  • GSN (GCN sequence number): 007003
  • GCN: 28380
  • GPI-14 (Medi-Span): 55104050103710
  • HICL (First Databank): 003031
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 998540
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.

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
  • It treats fungal and yeast infections. Depending on the product, that means vaginal yeast infections, athlete's foot, jock itch, ringworm, or thrush in the mouth and throat (Oravig...
  • Apply it to your upper gum in the morning after brushing, with dry hands. Hold it in place for 30 seconds. Don't crush, chew or swallow it. Use it once a day for 14 days.
  • Most are mild, like diarrhea, nausea, headache, upper belly pain or a change in taste. Vaginal products may cause mild burning or itching at first. Stop and get help for hives, tro...
  • Tell me if you take warfarin. Miconazole can boost its blood-thinning effect, so watch for bleeding or bruising. With Oravig, oral diabetes medicines, phenytoin and ergot alkaloids...
📖 Read our full Miconazole guide →
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.

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 systemPer gPer 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
Dec 2021 Mar 2022 Jul 2022 Nov 2022 $0.136 $0.116
▲ 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63868-0198-45 You're viewing this Main listing 1 TUBE, WITH APPLICATOR in 1 CARTON / 45 g in 1 TUBE, WITH APPLICATOR 2010-07-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Miconazole 7 2 g/100g 00113-0214-29 L 1 tube $0.119 — Availability likely save 9%
good sense miconazole 7 2 g/100g 00113-0825-29 L. 1 tube $0.119 — Availability likely save 9%
Miconazole 7 20 mg/g 00904-7734-45 Major 1 tube $0.119 — Availability likely save 9%
Good Neighbor Pharmacy Miconazole 7 2 g/100g 24385-0590-29 Amerisource 1 tube $0.119 — Availability likely save 9%
Miconazole Nitrate 20 mg/g 51672-2035-06 Sun 1 tube $0.119 — Availability likely save 9%
Miconazole 7 20 mg/g 61269-0730-41 H2-Pharma, 1 tube $0.119 — Availability likely save 9%
Miconazole 7 20 mg/g 70000-0009-01 Cardinal 1 tube $0.119 — Availability likely save 9%
foster and thrive miconazole 2 g/100g 70677-1222-01 Strategic 1 tube $0.119 — Availability likely save 9%
foster and thrive miconazole 7 2 g/100g 70677-1225-01 Strategic 1 tube $0.119 — Availability likely save 9%
Miconazole 7 20 mg/g 83324-0160-15 QUALITY 1 tube $0.119 — Availability likely save 9%
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.

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.

🧪 Avoiding an ingredient? See Miconazole inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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.

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.

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 16 words ▾

Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

⏱️ Dosage and Administration 102 words ▾

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 ~1 min read ▾

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 11 words ▾

Active ingredient Miconazole nitrate, USP 2% (100 mg in each applicator)

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

🎯 Purpose 3 words ▾

Purpose Vaginal antifungal

📄 Do Not Use 17 words ▾

Do not use i f you have never had a vaginal yeast infection diagnosed by a doctor

📄 Ask a Doctor Before Use If 83 words ▾

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 23 words ▾

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 59 words ▾

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 37 words ▾

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 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Questions or Comments 6 words ▾

Questions? Call 1-800-935-2362 Monday–Friday 9AM-5PM EST

📄 Package Label / Principal Display Panel 92 words ▾

Principal display panel *Compare to the active ingredient in MONISTAT® 7 Vaginal Cream Miconazole 7 Miconazole Nitrate Vaginal Cream USP, 2% Vaginal Antifungal (Miconazole Nitrate 100 mg per applicator) Cures Most Vaginal Yeast Infections and Relieves Associated External Itching and Irritation OZ NET WT (g) Tube Vaginal Cream with Reusable Applicator *This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®. Distributed by CDMA, Inc. Novi, MI 48375 www.qualitychoice.com

Package label QUALITY CHOICE Vaginal Antifungal Cream Miconazole nitrate USP, 2% (100 mg in each applicator)

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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

Vulvovaginal Burning Sensation665
Condition Aggravated261
Vulvovaginal Pain238
Vulvovaginal Pruritus207
Vulvovaginal Discomfort175
Vaginal Haemorrhage95
Vulvovaginal Swelling79

Age at onset

Neonate1
Infant3
Child3
Adolescent2
Adult109
Elderly64

Reporter sex

2,552 reports
Male · 12%
Female · 88%
Unknown · 0%

Serious outcomes

Hospitalization311
Death88
Life-threatening54
Disabling24
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 223 155
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.
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.