Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Remedy Antifungal Miconazole Nitrate 2 g/100g Powder, 85 g — NDC 53329-169-79 (Billing 53329-0169-79)
by Medline Industries, LP · 85 g in 1 BOTTLE
This is a package of 85 g of Remedy Antifungal Miconazole Nitrate 2 g/100g Powder from Medline Industries, LP, marketed since Nov 2012 and currently FDA-listed. It is this product's only package size.
NDC 53329-0169-79
🏷️ FDA NDC (as labeled)
53329-169-79
billing pads the product segment with a zero
🗂️ FDA directory synced Oct 8, 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 →
NDC database record
One package, one record: these facts belong to NDC 53329-169-79 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 53329 labeler · 169 product · 79 package
- Package marketed since
- Nov 19, 2012
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 85 g per package
- Barcode (UPC)
- 0080196528564
- 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 ↗
Past resolved recalls for this product (1)
Class II · Oct 4, 2023 · Terminated — CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0091-2024
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
53329-169-79
Product NDC
53329-169
11-digit billing NDC
53329016979
NCPDP billing unit
GM — per gram (weight)
RxCUI
998461
UNII
VW4H1CYW1K
UPC
0080196528564
Application #
M005
SPL Set ID
021b4a31-d7f6-4921-b4b1-cbe832eecd93
Established class (EPC)
Azole Antifungal
Chemical class
Azoles
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2012-11-19
Route
TOPICAL
Dosage form
POWDER
Substance
MICONAZOLE NITRATE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
90154050102910
GPI class
Remedy Phytoplex Antifungal
GCN Seq No
007367
GCN
30410
HICL code
003031
Ingredient (HICL)
Miconazole Nitrate
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q5
Therapeutic class — intermediate (HIC2)
Agents Acting Principally On The Skin
HIC3 code
Q5F
Therapeutic class — specific (HIC3)
Topical Antifungals
AHFS code
84:04.08.08
AHFS class
Azoles (Skin And Mucous Membrane)
FDB label name
REMEDY PHYTOPLEX ANTIFUNGAL 2%
FDB brand name
Remedy Phytoplex Antifungal
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 007367
- GCN: 30410
- GPI-14 (Medi-Span): 90154050102910
- HICL (First Databank): 003031
- AHFS class code: 84:04.08.08
- RxCUI (RxNorm): 998461
Why two NDCs?
The FDA registers this code as 53329-169-79 — 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 → 53329-0169-79. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 8, 2026
Clinical
Label name REMEDY PHYTOPLEX ANTIFUNGAL 2% Ingredient Miconazole Nitrate
📖 What it is MedlinePlus · NLM
Topical miconazole is used to treat tinea corporis(ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection. Not all products should be used to treat all of these conditions. Please read the label for each product to select the one to treat your conditi...
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...
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.
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
💬 Questions about Miconazole Nitrate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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.
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 9, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 53329-0169-79 You're viewing this Main listing | 85 g in 1 BOTTLE | 2012-11-19 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Miconazorb AF 20 mg/g 46122-0789-29 | AmerisourceBergen | 71 g | $0.058 | — | Availability likely | — |
| Miconazole Nitrate 1.42 g/71g 70000-0323-01 | LEADER/ | 71 g | $0.058 | — | Discontinued | — |
| Antifungal Powder 20 mg/g 70000-0679-01 | LEADER/ | 71 g | $0.058 | — | Availability likely | — |
| Desenex 20 mg/g 00316-0225-15 | Crown | 43 g | — | — | Discontinued | — |
| Zeasorb Athletes Foot 20 mg/g 00316-8000-01 | Crown | 71 g | — | — | FDA listed | — |
| Zeasorb Jock Itch 20 mg/g 00316-8001-02 | Crown | 71 g | — | — | FDA listed | — |
| Foot Powder 20 mg/g 00363-7999-01 | Walgreens | 71 g | — | — | FDA listed | — |
| Jock Itch Powder 20 mg/g 00363-9223-01 | Walgreens | 71 g | — | — | FDA listed | — |
| Miconazole Nitrate Antifungal Powder 2 g/100g 10135-0720-85 | Marlex | 85 g | — | — | FDA listed | — |
| Lotrimin AF Jock Itch 20 mg/g 11523-0150-01 | Bayer | 177 g | — | — | FDA listed | — |
| Lotrimin Antifungal 20 mg/g 11523-0919-01 | Bayer | 90 g | — | — | FDA listed | — |
| Micro-Guard (AF) 20 mg/g 11701-0038-16 | Coloplast | 85 g | — | — | FDA listed | — |
| Anti-Fungal Powder 20 mg/g 30142-0947-71 | The | 71 g | — | — | FDA listed | — |
| Miconazole Nitrate 1.42 g/71g 36800-0385-25 | Topco | 71 g | — | — | Discontinued | — |
| Anti-Fungal Powder 20 mg/g 36800-0613-01 | TopCo | 71 g | — | — | FDA listed | — |
| Miconazole Nitrate 2 g/100g 42291-0938-85 | AvKARE | 85 g | — | — | FDA listed | — |
| Anti-Fungal Powder 20 mg/g 51316-0980-01 | CVS | 71 g | — | — | FDA listed | — |
| Remedy Antifungal 2 g/100gthis 53329-0169-79 | Medline | 85 g | — | — | FDA listed | — |
| Miconazole Nitrate 20 mg/g 53943-0976-01 | Discount | 71 g | — | — | FDA listed | — |
| ProCure Antifungal 2 g/100g 55681-0043-03 | Twin | 85 g | — | — | FDA listed | — |
| Anti- Fungal Miconazole Nitrate 1.42 g/71g 56104-0253-01 | Premier | 71 g | — | — | FDA listed | — |
| Anti-fungal Powder Miconazole Nitrate 20 mg/g 56104-0500-00 | Premier | 71 g | — | — | FDA listed | — |
| Medicated Athletes Foot Powder 20 mg/g 56104-0906-01 | Premier | 99 g | — | — | FDA listed | — |
| Mycozyl AP 2 g/85g 59088-0442-07 | PureTek | 85 g | — | — | FDA listed | — |
| Micotrin AP 2 g/85g 59088-0478-07 | PureTek | 85 g | — | — | FDA listed | — |
| 1236-CS Antifungal Powder (Talc Free) 20 mg/g 67777-0313-04 | Dynarex | 24 bottles | — | — | FDA listed | — |
| THERA Antifungal Body 20 mg/g 68599-0207-03 | McKesson | 85 g | — | — | FDA listed | — |
| GeriGentle Miconazole nitrate 2 g/100g 69771-0165-03 | GERI-GENTLE | 85 g | — | — | FDA listed | — |
| Miconazole Nitrate 1.42 g/71g 69842-0490-25 | CVS | 71 g | — | — | FDA listed | — |
| Miconazole Nitrate 1.42 g/71g 72446-0007-71 | Hudson | 71 g | — | — | FDA listed | — |
| Miconazole Nitrate 20 mg/g 72446-0014-01 | Hudson | 71 g | — | — | FDA listed | — |
| DCH Labs Antifungal Jock 2 g/100g 72839-0096-02 | Derma | 71 g | — | — | FDA listed | — |
| Warrior Antifungal Foot 2 g/100g 72839-0961-02 | Derma | 71 g | — | — | FDA listed | — |
| Anti-fungal Powder Miconazole Nitrate 20 mg/g 79481-0621-01 | Meijer | 71 g | — | — | FDA listed | — |
| Antifungal 20 mg/g 80513-0771-03 | Advanced | 85 g | — | — | FDA listed | — |
| Evercare Antifungal Treatment Super Absorbent Powder 20 mg/g 83099-0000-00 | PANEFFORT, | 85 g | — | — | FDA listed | — |
| Dermachange Jock 2 g/100g 83520-0961-02 | Private | 71 g | — | — | FDA listed | — |
| Happy Nuts Jock Itch Powder 2 g/100g 87151-0111-01 | Suit | 71 g | — | — | FDA listed | — |
| Antifungal Powder 2 g/100g 87236-0012-03 | Aldermed | 85 g | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2012
On the market since
Nov 2012
📍
2026
Currently FDA-listed
14 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
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.
- FDA Orange Book · refreshed Oct 3, 2026
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 9E8X80D2L0
A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
-
UNII BK1IU07GKF
A steroid compound naturally found in skin and other tissues. It serves as a precursor ingredient that helps stabilize the formulation and may support the product's intended chemical stability.
-
UNII 49VG1X560X
A blue-green algae used as a natural colorant and nutritional ingredient in some formulations. It adds color to the medicine and may serve as a filler or binder to give the product structure and form.
-
UNII U73D397055
A blend of plant-derived fats and oils that act as a liquid carrier and solvent in medicines. It helps dissolve active ingredients and improve how the body absorbs them from capsules or liquid formulations.
-
UNII K48IKT5321
A plant extract from clove buds used as a flavoring agent and natural fragrance in medications. It adds taste and aroma to improve how the medicine smells and tastes.
-
UNII 8470G57WFM
Corn oil is a vegetable oil extracted from corn kernels. It's used in medicines as a solvent to dissolve active ingredients and help the body absorb them, and sometimes as a lubricant in capsules.
-
UNII 1Z74184RGV
Egg phospholipids are naturally derived fats from eggs that help mix oil and water-based ingredients together. They work as emulsifiers in medicines, keeping the formula stable and uniform.
-
UNII 9A87HC7ROD
A synthetic compound used as a plasticizer and conditioning agent in tablet coatings and film formulations. It helps make coatings flexible and improves how they cling to the tablet surface.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII CA2Y0FE3FX
A salt derived from licorice root extract, used as a flavoring agent and sweetener. It may also help soothe and protect mucous membranes in throat lozenges and cough products.
-
UNII W2ZU1RY8B0
A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
-
UNII Y6O7T4G8P9
Hydrated silica is a fine powder form of silicon dioxide with absorbed water. It works as an anti-caking agent and absorbent in medicines, helping powders stay free-flowing and preventing clumping.
-
UNII 0RE8K4LNJS
Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
-
UNII 3GW44CIE3Y
A synthetic fragrance compound used to add pleasant scent to medicines. It helps mask unpleasant tastes or odors in oral products and may improve patient acceptance of the medication.
-
UNII OJ245FE5EU
Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
-
UNII R44IWB3RN5
Soy protein is a plant-based protein derived from soybeans. It's used in medicines as a binder to hold tablet ingredients together and sometimes as a filler to add bulk and texture to the formulation.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
-
UNII Q74T35078H
Vanilla is a flavoring ingredient extracted from vanilla orchid beans. It's added to medicines to improve taste and make them more pleasant to take, especially for children or patients who need liquid formulations.
-
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.
-
UNII 3NY3SM6B8U
A microorganism used as a natural source of B vitamins and proteins. In medications, yeast serves as a nutrient supplement and may help with tablet binding or act as a filler to give the product proper form and stability.
20 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesAphanizomenon Flos-Aquae (Algae) Extract, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglycerides, 7-Dehydrocholesterol, Dipotassium Glycyrrhizate, Ethylene Brassylate, Eugenia Caryophyllus (Clove) Flower Extract, Fragrance, Glycerin, Hydrolyzed Soy Protein, Phospholipids, Silica, Sodium Benzoate, Tocopheryl Acetate, Water, Yeast Ferment Extract, Zea Mays (Corn) Oil, Zea Mays (Corn) Starch
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.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
LabelerMedline Industries, LP
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code53329
First marketedNov 2012
Product typeHuman Otc Drug
Portfolio120 products on file
More NDCs from Medline Industries, LP labeler code 53329
- Medline menthol, white petrolatum, zinc oxide 206 mg/g; 4.4 mg/g; 530 mg/g Paste NDC 53329-156-14
- Remedy Nutrashield Dimethicone 1 g/100mL Lotion NDC 53329-157-02
- Medline dimethicone 125 mg/mL Cream NDC 53329-159-04
- Remedy Antifungal With Olivamine Miconazole Nitrate 2 g/100g Cream NDC 53329-162-04
- Medline white petrolatum, zinc oxide 71.5 g/100g; 1 g/100g Ointment NDC 53329-163-10
- REMEDY Calazime Skin Protectant calamine, menthol, white petrolatum, zinc oxide .5 g/100g; .2 g/100g; 19.5 g/100g; 69 g/100g Paste NDC 53329-165-02
- Medline miconazol nitrate 2 g/100g Ointment NDC 53329-172-10
- Medline zinc oxide, petrolatum 20 g/100g; 78 g/100g Cream NDC 53329-176-14
- Cleanse Benzalkonium Chloride 0.13% .13 g/100mL Solution NDC 53329-177-04
- ReadyBath Luxe Benzalkonium Chloride .12 g/100g Cloth NDC 53329-180-76
- ReadyBath Luxe Benzalkonium Chloride .12 g/100g Cloth NDC 53329-181-76
- ReadyBath Select Benzalkonium Chloride .12 g/100g Cloth NDC 53329-182-76
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 openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 When Using This Product
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
⏱️ Dosage and Administration ▾
Directions Clean the affected area and dry thoroughly Apply a thin layer of powder over affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this product For athlete's foot, pay special attention between spaces in toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily For athlete's foot and ringworm, use daily for 4 weeks For jock itch, use daily for 2 weeks If condition persists longer, consult a doctor This product is not effective on the scalp or nails.
⚠️ Warnings ▾
Warnings For external use only Do not use on children under 2 years of age unless directed by a doctor on scalp or nails When using this product avoid contact with the eyes Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks when used for the treatment of athlete's foot or ringworm there is no improvement within 2 weeks when used for the treatment of jock itch Keep out of reach of children If swallowed, get medical help or contact a Poison Control center right away.
📦 Storage and Handling ▾
Other Information protect from freezing. Avoid excessive heat. do not use if package is damaged keep dry
🧪 Active Ingredient ▾
Active ingredient Miconazole nitrate 2.0% w/w
🧪 Inactive Ingredients ▾
Inactive ingredients Aphanizomenon Flos-Aquae (Algae) Extract, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglycerides, 7-Dehydrocholesterol, Dipotassium Glycyrrhizate, Ethylene Brassylate, Eugenia Caryophyllus (Clove) Flower Extract, Fragrance, Glycerin, Hydrolyzed Soy Protein, Phospholipids, Silica, Sodium Benzoate, Tocopheryl Acetate, Water, Yeast Ferment Extract, Zea Mays (Corn) Oil, Zea Mays (Corn) Starch
🎯 Purpose ▾
Purpose Antifungal
📄 Do Not Use ▾
Do not use on children under 2 years of age unless directed by a doctor on scalp or nails
📄 When Using This Product ▾
When using this product avoid contact with the eyes
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks when used for the treatment of athlete's foot or ringworm there is no improvement within 2 weeks when used for the treatment of jock itch
📄 Keep Out of Reach of Children ▾
Keep out of reach of children If swallowed, get medical help or contact a Poison Control center right away.
📄 Package Label / Principal Display Panel ▾
Package Label Package Label
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 ↗
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 Remedy Antifungal (this brand).
Top reported reactions
Reporter sex
Male · 24%
Female · 76%
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.
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
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Medline Industries, LP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Medline Industries, LP 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.
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.