Miconazole Nitrate 20 mg/g Cream
by Sun Pharmaceutical Industries, Inc. · 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-7) / 45 g in 1 TUBE, WITH APPLICATOR
NDC 51672-2035-07
🏷️ FDA NDC (as labeled)
51672-2035-7
billing pads the package segment with a zero
This package
Contains45 g in 1 tube, with applicator
Pack sizes2 compare ↓
Also comes in:
45 g 51672-2035-06
OTC
Generic
On market
Non-controlled
🗂️ Data synced Sep 17, 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)
51672-2035-7
Product NDC
51672-2035
11-digit billing NDC
51672203507
Application #
ANDA074444
SPL Set ID
6b34d0be-4bcd-4dff-b732-7fbd46765019
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
1997-01-13
Route
VAGINAL
Dosage form
CREAM
Substance
MICONAZOLE NITRATE
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
MICONAZOLE 2% VAGINAL CREAM
FDB brand name
Miconazole Nitrate
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 51672-2035-7 — a 5-4-1 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 package segment → 51672-2035-07. 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.
🏭 Manufacturer & labeler
LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMA CANADA INC
FDA applicationANDA074444 (ANDA)
Labeler code51672
First marketedJan 1997
Product typeHuman Otc Drug
Portfolio889 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 MICONAZOLE 2% VAGINAL CREAM Ingredient Miconazole Nitrate
📗 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.
🧪 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 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 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
-
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 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.
4 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesbenzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and 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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| 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. | |
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size:
45 g
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 | — |
| good sense miconazole 7 2 g/100g 00113-0825-29 | L. | 1 tube | $0.122 | — | Availability likely | — |
| Miconazole 7 20 mg/g 00904-7734-45 | Major | 1 tube | $0.122 | — | Availability likely | — |
| Good Neighbor Pharmacy Miconazole 7 2 g/100g 24385-0590-29 | Amerisource | 1 tube | $0.122 | — | Availability likely | — |
| Miconazole 7 20 mg/g 61269-0730-41 | H2-Pharma, | 1 tube | $0.122 | — | Availability likely | — |
| Miconazole 7 20 mg/g 70000-0009-01 | Cardinal | 1 tube | $0.122 | — | Availability likely | — |
| foster and thrive miconazole 2 g/100g 70677-1222-01 | Strategic | 1 tube | $0.122 | — | Availability likely | — |
| foster and thrive miconazole 7 2 g/100g 70677-1225-01 | Strategic | 1 tube | $0.122 | — | Availability likely | — |
| Miconazole 7 20 mg/g 83324-0160-15 | QUALITY | 1 tube | $0.122 | — | Availability likely | — |
| Miconazole 7 20 mg/g 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 Nitrate 20 mg/gthis 51672-2035-07 | Sun | 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
🏛️
1997
On the market since
Jan 1997
📍
2026
Currently FDA-listed
29 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.
💊 Medicaid utilization by pack size
Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 16,647 Rx · 740,081 units · $187,758 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
📊 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 Nitrate — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 18%
Female · 81%
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 | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 51672-2035-06 | 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-6) / 45 g in 1 TUBE, WITH APPLICATOR | $0.1215 / g | $5.47 | 1997-01-13 | Active |
| 51672-2035-07 You're viewing this | 1 TUBE, WITH APPLICATOR in 1 CARTON (51672-2035-7) / 45 g in 1 TUBE, WITH APPLICATOR | — | — | 1997-01-13 | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 51672-2035-07?
NDC 51672-2035-07 is listed by the FDA — 1 tube, with applicator in 1 carton / 45 g in 1 tube, with applicator.
What NDC number is used to bill for this package of Miconazole Nitrate 20 mg/g Cream?
Bill NDC 51672-2035-07 — the 11-digit billing format is 51672203507. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 51672-2035-7, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51672-2035-07, written without dashes as 51672203507. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51672-2035-07, the first segment (51672) is the labeler code FDA assigned to Sun Pharmaceutical Industries, Inc.; the middle segment (2035) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Sun Pharmaceutical Industries, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tube (51672-2035-06). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 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
📦 Storage and Handling
🧪 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 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 (1-800-222-1222) right away.
📦 Storage and Handling ▾
Other information do not purchase if carton is opened do not use if seal over tube opening has been punctured or is not visible store at 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date
🧪 Active Ingredient ▾
Active ingredient Miconazole nitrate USP 2% (100 mg in each applicatorful)
🧪 Inactive Ingredients ▾
Inactive ingredients benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and 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.