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Triple Antifungal Miconazole Nitrate 2 g/100g Ointment, 1 tube — NDC 16864-0040-02 package photo

Triple Antifungal Miconazole Nitrate 2 g/100g Ointment, 1 tube

by Advantice Health, LLC · 1 TUBE in 1 CARTON (16864-040-02) / 56.7 g in 1 TUBE
NDC 16864-0040-02
🏷️ FDA NDC (as labeled) 16864-040-02 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
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) 16864-040-02
Product NDC 16864-040
11-digit billing NDC 16864004002
NCPDP billing unit GM — per gram (weight)
RxCUI 998442, 998460
UNII VW4H1CYW1K
Application # M005
SPL Set ID 9a47fb1b-a41f-4c8a-8e43-7332853c308e
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 2021-09-01
Route TOPICAL
Dosage form OINTMENT
Substance MICONAZOLE NITRATE
GPI-14 90154050104210
GPI class Triple Paste AF
GCN Seq No 047965
GCN 13394
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 TRIPLE PASTE AF 2% OINTMENT
FDB brand name Triple Paste Af
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 16864-040-02 — 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 → 16864-0040-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Imidazole derivatives, Imidazole and triazole derivatives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAdvantice Health, LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code16864
First marketedSep 2021
Product typeHuman Otc Drug
Portfolio11 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 TRIPLE PASTE AF 2% OINTMENT 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
  • 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?
📖 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.

💊 What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • 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 7EV65EAW6H
    Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • UNII Z6J799EAJK
    Oat is a cereal grain used in medicines as a filler and binder. It helps give the medication its shape and structure while adding bulk 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 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • 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 B6E5W8RQJ4
    White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.

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

The official label also statesWhite petrolatum, zinc oxide, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, cholesterol.

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 systemPer gPer 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Antifungal Cream 2 g/100g 21922-0095-06 Encube 1 tube $0.080 — Availability likely —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 00536-1375-75 Rugby 1 tube $0.119 — Availability likely —
Critic Aid Clear AF 20 mg/g 11701-0067-14 Coloplast 142 g — — FDA listed —
Green Tetterine 2 g/100g 12258-0241-01 S.S.S. 1 can — — FDA listed —
White Tetterine 2 g/100g 12258-0242-01 S.S.S. 1 tube — — FDA listed —
Triple Antifungal 2 g/100gthis 16864-0040-02 Advantice 1 tube — — FDA listed —
Medline 2 g/100g 53329-0172-10 Medline 71 g — — FDA listed —
Antifungal 2 g/100g 84722-3060-00 VIVE 1 g — — FDA listed —
MacerRx Web 2 g/100g 44577-0205-56 Clinical 1 tube — — FDA listed —
Nedtol Folliculitis Treatment Creams 2 g/100g 84867-0022-01 Jiashen 120 g — — FDA listed —
Miconazole Cream 2 g/100g 87236-0013-04 Aldermed 113 g — — FDA listed —
Lasolex AG 2 g/100g 59088-0207-07 Puretek 85 g — — FDA listed —
Kerova Miconazole Nitrate 2 g/100g 85959-0001-01 Guangzhou 100 g — — FDA listed —
Femmesil Maximum Strength 2 g/100g 24909-0202-28 Aidance 1 bottle — — Discontinued —
BOA VIDA Antifungal 2 g/100g 62654-0147-01 Central 113 g — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 68788-8845-03 Preferred 1 tube — — FDA listed —
MICONAZOLE Nitrate 2% 2 g/100g 71399-0071-01 Akron 1 tube — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 68788-8895-03 Preferred 1 tube — — FDA listed —
Doctor Jiao Antifungal Cream 2 g/100g 87537-0002-02 Jiangxi 1 tube — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 77338-0041-25 ASTONEA 113 g — — FDA listed —
Remedy Antifungal With Olivamine 2 g/100g 53329-0162-04 Medline 113 g — — Discontinued —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 69396-0014-05 Trifecta 15 g — — FDA listed —
FifthPulse Miconazole Nitrate Cream 4oz 2 g/100g 69571-0017-01 Front 113.4 g — — FDA listed —
Antifungal 2 g/100g 67777-0710-02 Dynarex 144 packets — — FDA listed —
MICONAZOLE Nitrate 2 g/100g 68071-3429-03 NuCare 1 tube — — FDA listed —
PiYanPing Antifungal 2 g/100g 69070-0304-01 Zhejiang 1 tube — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 69771-0041-25 GERI-GENTLE 113 g — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 70000-0718-01 Cardinal 1 tube — — FDA listed —
Claravie 2 g/100g 61554-0305-11 Gentell 113 g — — FDA listed —
MOROVANJock Itch Antifungal 2 g/100g 87800-0006-01 HONG 100 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.

⏳ Availability & generic status

🏛️
2021
On the market since
Sep 2021
📍
2026
Currently FDA-listed
5 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.

📊 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
16864-0040-02 You're viewing this 1 TUBE in 1 CARTON (16864-040-02) / 56.7 g in 1 TUBE 2021-09-01 Active

🧭 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 FDA registers it as 16864-040-02, 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: 16864-0040-02, written without dashes as 16864004002. 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 16864-0040-02, the first segment (16864) is the labeler code FDA assigned to Advantice Health, LLC; the middle segment (0040) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Advantice Health, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Advantice Health, LLC 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 29 words ▾

Uses For the treatment of superficial skin infections caused by yeast (Candida albicans) Relieves discomfort, irrit.ation, redness and chafing associated with jock itch Cures most jock itch (tinea cruris)

⏱️ Dosage and Administration 57 words ▾

Directions Clean affected area and dry thoroughly Apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this product Use daily for 2 weeks; If condition persists longer, consult a doctor This product is not effective on the scalp or nails

⚠️ Warnings 64 words ▾

Warnings For external use only When using this product avoid contact with the eyes. Stop use and ask a doctor if irritation occurs there is no improvement within 2 weeks Do not use on children under 2 years of age unless directed by a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 10 words ▾

Other information Store at room temperature 15°– 30°C (59°– 86°F)

🧪 Active Ingredient 5 words ▾

Active ingredient Miconazole nitrate 2%

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients White petrolatum, zinc oxide, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, cholesterol.

🎯 Purpose 2 words ▾

Purpose Antifungal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 16864-0031-01 · Advantice 16864-0041-01 · Advantice →
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.