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Mata Hongos Undecylenic Acid 2 mg/10mL Spray, 30 mL — NDC 69469-0201-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Mata Hongos Undecylenic Acid 2 mg/10mL Spray, 30 mL — NDC 69469-201-01 (Billing 69469-0201-01)

by Vitamex USA, Corp · 30 mL in 1 BOTTLE, SPRAY

This is a package of 30 mL of Mata Hongos Undecylenic Acid 2 mg/10mL Spray from Vitamex USA, Corp, marketed since Sep 2024 and currently FDA-listed. It is this product's only package size.

NDC 69469-0201-01
🏷️ FDA NDC (as labeled) 69469-201-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ 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 →

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 69469-201-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69469 labeler · 201 product · 01 package
Package marketed since
Sep 9, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6946920101 5
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Undecylenic Acid (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 8, 2026 — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry (Blaine Labs Inc) · FDA recall D-0697-2026
Class II · Apr 8, 2026 — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry (Blaine Labs Inc) · FDA recall D-0694-2026
Class II · Apr 8, 2026 — CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry (Blaine Labs Inc) · FDA recall D-0695-2026
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) 69469-201-01
Product NDC 69469-201
11-digit billing NDC 69469020101
UNII K3D86KJ24N
Application # M005
SPL Set ID 21ca7edb-dde3-5846-e063-6394a90a3cc0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-09
Route TOPICAL
Dosage form SPRAY
Substance UNDECYLENIC ACID
Why two NDCs? The FDA registers this code as 69469-201-01 — 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 → 69469-0201-01. 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.

Clinical

🧪 What is this product?

Mata Hongos Undecylenic Acid 2 mg/10mL Spray is a topical OTC spray product marketed under FDA's OTC monograph rules for antifungal agents. It contains undecylenic acid, a fatty acid commonly used in over-the-counter antifungal products to help reduce fungal growth on skin. This spray form is typically used for topical application to affected areas.

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 mLPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69469-0201-01 You're viewing this Main listing 30 mL in 1 BOTTLE, SPRAY 2024-09-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mata Hongos 2 mg/10mLthis 69469-0201-01 Vitamex 30 ml — — FDA listed —
Hongo Killer 2 mg/10mL 58593-0601-15 Efficient 1 bottle — — 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

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 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.

What it looks like

Color yellow
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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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.

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

The official label also statesInactive Ingredientes: Alcohol, 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.

Manufacturer & labeler

LabelerVitamex USA, Corp
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code69469
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from Vitamex USA, Corp labeler code 69469

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 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 70 words ▾

Directions Directions Wash the affected area and dry throughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor. Pay special attention to spaces between the toes; wear well-fitting ventialted shoes and change shoes and socks at least once daily. This product is not effective on the scalp or nails. Supervise children in the use of this product.

⏱️ Dosage and Administration 70 words ▾

Directions Directions Wash the affected area and dry throughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor. Pay special attention to spaces between the toes; wear well-fitting ventialted shoes and change shoes and socks at least once daily. This product is not effective on the scalp or nails. Supervise children in the use of this product.

⚠️ Warnings 24 words ▾

Warnings For External Use Only Avoid contact with the eyes. Do not use: on children under 2 years of age unless directed by doctor.

🧪 Active Ingredient 9 words ▾

Active Ingredient Active Ingredient: Purpose: Undecylenic Acid 20% Antifungal

🧪 Inactive Ingredients 7 words ▾

Inactive Ingredients Inactive Ingredientes: Alcohol, Purified Water

🎯 Purpose 21 words ▾

Uses: For the treament of athlete's foot. Soothes itching, scailing, cracking, redness, soreness and between the toes or itching, burning feet.

📄 Stop Use and Ask a Doctor If 24 words ▾

Stop use and ask a doctor Stop use and ask a doctor: if irritation occurs or if there is no improvement within 4 weeks.

🤰 If Pregnant or Breast-Feeding 34 words ▾

If pregnant or breastfeeding If pregnant or breastfeeding, ask health professional before use. Keep out or reach of children In case of ingestion, get medical help or contct a Poison Control Center right away.

📄 Keep Out of Reach of Children 36 words ▾

Keep out of reach of children If pregnant or breastfeeding, ask health professional before use. Keep out or reach of children In case of ingestion, get medical help or contct a Poison Control Center right away.

📄 Other Information 29 words ▾

Other Information Other Information Store at controlled room temperature: 15-30°C (59-86°F) Tamper Evident Feature: Do not use cello-band over cap is torn, broken or missing. Close tightly after use.

📄 Package Label / Principal Display Panel 16 words ▾

Mata Hongos Mata Hongos Antifungal spray (Athlete's Foot) Net Cont. 1 Fl. Oz (30mL) Mata Hongos

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Mata Hongos (this brand).

Top reported reactions

Treatment Failure3
Intentional Dose Omission2
Nausea2
Vision Blurred2
Abdominal Discomfort1
Abdominal Pain Upper1
Ankle Fracture1

Age at onset

Adult1
Elderly1

Reporter sex

20 reports
Male · 50%
Female · 50%

Serious outcomes

Death1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 3 0
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 Vitamex USA, Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Vitamex USA, Corp 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.
← 69469-0100-04 · Vitamex 69469-0650-05 · Vitamex →
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.