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Miconazole 7 Miconazole Nitrate 100 mg Suppository, 7 suppositories — NDC 49348-0833-61 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 100 mg Suppository, 7 suppositories — NDC 49348-833-61 (Billing 49348-0833-61)

by Strategic Sourcing Services LLC · 7 SUPPOSITORY in 1 APPLICATOR

This is a package of 7 suppositories of Miconazole 7 Miconazole Nitrate 100 mg Suppository from Strategic Sourcing Services LLC, marketed since Dec 2011 and currently FDA-listed, this package's marketing is listed to end Dec 2026; retail pharmacies pay about $1.13 per suppositorie (NADAC). It is this product's only package size.

NDC 49348-0833-61
🏷️ FDA NDC (as labeled) 49348-833-61 billing pads the product segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 49348-833-61 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
49348 labeler · 833 product · 61 package
Package marketed since
Dec 9, 2011
Package marketing ended
Dec 9, 2026
Sample package
No — commercial package
Billing quantity
7 EA per package
Barcode (UPC)
0010939046338
FDA record last changed
Jul 24, 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) 49348-833-61
Product NDC 49348-833
11-digit billing NDC 49348083361
NCPDP billing unit EA — each (per item)
RxCUI 992780
UNII VW4H1CYW1K
UPC 0010939046338
Application # ANDA073507
SPL Set ID 89132802-beb1-42f4-8da4-39918fc5c4dd
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 2011-12-09
Marketing end 2026-12-09
Route VAGINAL
Dosage form SUPPOSITORY
Substance MICONAZOLE NITRATE

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

GPI-14 55104050105205
GPI class SM Miconazole 7
GCN Seq No 007004
GCN 28390
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 SM MICONAZOLE 7 100 MG VAG SUP
FDB brand name Miconazole 7
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 007004
  • GCN: 28390
  • GPI-14 (Medi-Span): 55104050105205
  • HICL (First Databank): 003031
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 992780
Why two NDCs? The FDA registers this code as 49348-833-61 — 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 → 49348-0833-61. 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 SM MICONAZOLE 7 100 MG VAG SUP Ingredient Miconazole Nitrate
📗 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eaPer package
Retail pharmacies payNADAC · weekly $1.133 $7.93 / 7 suppositories
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 ea) — tap or hover for the price & month
Nov 2021 May 2022 Sep 2022 Apr 2023 $1.172 $1.035
▲ Up 4% over the last 7 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
49348-0833-61 You're viewing this Main listing 7 SUPPOSITORY in 1 APPLICATOR 2011-12-09 Dec 9, 2026 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Miconazole 7 100 mgthis 49348-0833-61 Strategic 7 suppositories $1.133 — 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

🏛️
2011
On the market since
Dec 2011
📍
2026
Currently FDA-listed
15 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.

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 FM8D1RE2VP
    A plant-based oil that has been chemically hardened to stay solid at room temperature. It works as a binder and lubricant to hold tablet ingredients together and help them release properly during digestion.
  • UNII B0S90M0233
    Palm kernel oil is a natural fat extracted from palm seeds. It's used in medicines as a lubricant and binder to help tablets hold together and flow smoothly during manufacturing.

2 inactive ingredients listed in the exact product block matched to this NDC.

The official label also stateshydrogenated vegetable oil

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

LabelerStrategic Sourcing Services LLC
Application holderCOSETTE PHARMACEUTICALS NC LABORATORIES LLC
FDA applicationANDA073507 (ANDA)
Labeler code49348
First marketedDec 2011
Product typeHuman Otc Drug
Portfolio316 products on file

More NDCs from Strategic Sourcing Services LLC labeler code 49348

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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 5 words ▾

Use treats vaginal yeast infections

⏱️ Dosage and Administration 50 words ▾

Directions before using this product read the enclosed consumer information leaflet for complete instructions and information adults and children 12 years of age and over: insert 1 suppository into the vagina at bedtime for 7 nights in a row. Wash applicator after use. children under 12 years: ask a doctor

⚠️ Warnings ~1 min read ▾

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 vaginal yeast infections often (such as once a month or 3 in 6 months). You may have a more serious condition. You could be pregnant or have a medical condition, such as diabetes or a weakened immune system. lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge been exposed to the human immunodeficiency virus (HIV) that causes AIDS Ask a doctor or pharmacist before use if you are taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur When using this product do not use tampons, douches, spermicides or other vaginal products do not use condoms or diaphragms.

They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse (sex) mild increase in vaginal burning, itching or irritation may occur Stop use and ask a doctor if side effects occur. 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 (1-800-222-1222) right away.

🧪 Active Ingredient 11 words ▾

Active ingredient (in each vaginal suppository) Miconazole nitrate, USP 100 mg

🧪 Inactive Ingredients 5 words ▾

Inactive ingredient hydrogenated vegetable oil

🎯 Purpose 3 words ▾

Purpose Vaginal antifungal

📄 Do Not Use 16 words ▾

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

📄 Ask a Doctor Before Use If 79 words ▾

Ask a doctor before use if you have vaginal itching and discomfort for the first time vaginal yeast infections often (such as once a month or 3 in 6 months). You may have a more serious condition. You could be pregnant or have a medical condition, such as diabetes or a weakened immune system. lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge been exposed to the human immunodeficiency virus (HIV) that causes AIDS

📄 Ask a Doctor or Pharmacist Before Use If 25 words ▾

Ask a doctor or pharmacist before use if you are taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur

📄 When Using This Product 52 words ▾

When using this product do not use tampons, douches, spermicides or other vaginal products do not use condoms or diaphragms. They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse (sex) mild increase in vaginal burning, itching or irritation may occur

📄 Stop Use and Ask a Doctor If 40 words ▾

Stop use and ask a doctor if side effects occur. 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 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.

📄 Other Information 37 words ▾

Other information do not purchase if carton is open each suppository is individually wrapped. Do not use if wrapper is missing or damaged. store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature] excursions permitted to 15º-30ºC (59º-86ºF).

📄 Questions or Comments 7 words ▾

Questions? Call 1 -877-753-3935 Monday-Friday 9AM-5PM EST

📄 Package Label / Principal Display Panel 74 words ▾

Principal display panel COMPARETO MONISTAT® 7 ACTIVE INGREDIENT* miconazole 7 Vaginal Suppositories Miconazole Nitrate Vaginal Suppositories, USP 100 mg Vaginal antifungal Cures most vaginal yeast infections 7 VAGINAL SUPPOSITORIES WITH 1 REUSABLE PLASTIC APPLICATOR *This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat® Distributed by McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141 www.sunmarkbrand.com

Package label SUNMARK Vaginal Suppositories Miconazole nitrate, USP 100 mg

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.
← 49348-0802-34 · Strategic 49348-0947-29 · Strategic →
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.