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PureWellness FUNGAL FUSION Antifungal and Antimicrobial Kit Kit — NDC 87817-0200-01 package photo

PureWellness FUNGAL FUSION Antifungal and Antimicrobial Kit Kit

by PureWellness LLC · 1 KIT in 1 CARTON (87817-200-01) * 1 BOTTLE in 1 KIT (87817-110-01) / 57 g in 1 BOTTLE * 1 BOTTLE, GLASS in 1 KIT (87817-101-01) / 30 mL in 1 BOTTLE, GLASS
NDC 87817-0200-01
🏷️ FDA NDC (as labeled) 87817-200-01 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

🆔 Identity & classification

FDA NDC (as labeled) 87817-200-01
Product NDC 87817-200
11-digit billing NDC 87817020001
RxCUI 313423, 998483
Application # M005
SPL Set ID 25db8c55-0fa9-4795-8e05-4d3a7aaf0148
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-06
Dosage form KIT
Why two NDCs? The FDA registers this code as 87817-200-01 — 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 → 87817-0200-01. 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 Other antifungals for topical use class.

Drug family (ATC) Other antifungals for topical use
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

LabelerPureWellness LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code87817
First marketedJul 2026
Product typeHuman Otc Drug
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

🧪 What is this product?

This is an over-the-counter kit marketed as an antifungal and antimicrobial product under FDA's monograph rules for OTC drugs in this category. The kit contains ingredients typically used to help address fungal and bacterial skin concerns. Because the specific active ingredients in this kit are not listed in the provided data, the exact formulation and intended use cannot be detailed here. Consumers should refer to the product labeling for a complete list of active ingredients and directions for use.

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.

🧪 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.

From the label’s inactive-ingredient sectionInactive Ingredients: Aloe Barbadensis Leaf Juice, Caprylic Capric Triglyceride, Cetyl Alcohol, Clotrimazole, Glyceryl Stearate, Disodium EDTA, Fragrance, Hydroxyethylcellulose, Lavendula Angustifolia (Lavender) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylparaben, PEG-100 Stearate, Polysorbate 60, Propylparaben, Purified Water, Stearic Acid, Tannic Acid, Triethanolamine Inactive Ingredients: Butylparaben, Butylated Hydroxyanisol, Butylated Hydroxytoluene, Carthmus Tinctorius (Safflower) Seed Oil, Ethylparaben, Isobutylparaben, Methylparaben, Origanum Vulgare (Oregano) Leaf Oil, Phenoxyethanol, Propylparaben, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, White Mineral Oil

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 eachPer 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
PureWellness FUNGAL FUSION Antifungal and Antimicrobial Kitthis 87817-0200-01 PureWellness 1 kit — — 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

🏛️
2026
On the market since
Jul 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
87817-0200-01 You're viewing this 1 KIT in 1 CARTON (87817-200-01) * 1 BOTTLE in 1 KIT (87817-110-01) / 57 g in 1 BOTTLE * 1 BOTTLE, GLASS in 1 KIT (87817-101-01) / 30 mL in 1 BOTTLE, GLASS 2026-07-06 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 87817-200-01, 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: 87817-0200-01, written without dashes as 87817020001. 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 87817-0200-01, the first segment (87817) is the labeler code FDA assigned to PureWellness LLC; the middle segment (0200) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 PureWellness LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PureWellness 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 59 words ▾

Uses■ cures most athlete’s foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) ■ relieves itching, cracking, burning and scaling, which accompany these conditions

Uses ■ cures most athlete’s foot (tinea pedis) relieves discomfort, irritation, cracking, scaly skin between the toes, and burning feet ■ clinically proven to prevent most athlete’s foot (tinea pedis) with daily use

⏱️ Dosage and Administration 218 words ▾

Directions ■ wash the affected area with soap and water, dry thoroughly, then apply sparingly over the affected area ■ use twice daily (morning and night) or as directed by a physician ■ for athlete’s foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change socks at least once, daily ■ for athlete’s foot and ringworm, use daily for four (4) weeks ■ for jock itch, use daily for two (2) weeks ■ if condition persists longer, consult a doctor ■ this product is not effective on the scalp or nails

Directions ■ clean the affected area and dry thoroughly ■ apply a thin layer of the product over the 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 ■ to spaces between the 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 ■ if condition persists longer, consult a doctor ■ this product is not effective on the scalp or nails to prevent athlete’s foot: wash the foot ■ thoroughly; apply a thin layer of the product to the feet once or twice daily (morning and night).

⚠️ Warnings 111 words ▾

Warnings - For external use only When using this product ■ avoid contact with the eyes: rinse immediately with cool tap water if contact occurs Stop use and ask a doctor : If irritation occurs or if there is no improvement within four (4) weeks (for athlete’s foot or ringworm), or within two (2) weeks (for jock’s itch)

Warnings - For external use only ■ on children under 2 years of age unless directed by a physician ■ in or near the mouth or eyes Stop use and ask a doctor : ■ If irritation occurs or if there is no improvement within four (4) weeks (for athlete’s foot or ringworm).

🧪 Active Ingredient 13 words ▾

Drug Facts Active Ingredient Miconazole Nitrate 2%

Drug Facts Active Ingredient Tolnaftate 1%........................................Antifungal

🧪 Inactive Ingredients 73 words ▾

Inactive Ingredients: Aloe Barbadensis Leaf Juice, Caprylic Capric Triglyceride, Cetyl Alcohol, Clotrimazole, Glyceryl Stearate, Disodium EDTA, Fragrance, Hydroxyethylcellulose, Lavendula Angustifolia (Lavender) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylparaben, PEG-100 Stearate, Polysorbate 60, Propylparaben, Purified Water, Stearic Acid, Tannic Acid, Triethanolamine

Inactive Ingredients: Butylparaben, Butylated Hydroxyanisol, Butylated Hydroxytoluene, Carthmus Tinctorius (Safflower) Seed Oil, Ethylparaben, Isobutylparaben, Methylparaben, Origanum Vulgare (Oregano) Leaf Oil, Phenoxyethanol, Propylparaben, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, White Mineral Oil

🎯 Purpose 5 words ▾

Purpose .......................Antifungal

Purpose Tolnaftate ..............Antifungal

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 87815-0006-01 · Guangzhou 87820-0150-02 · Sundoesmatter →
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.