Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Solucion Antiseptica Dermoxine Solucion antiseptica topica a base de alcohol etilico .97 g/100mL; 70 mL/100mL Liquid — NDC 58345-106-04 (Billing 58345-0106-04)
by Key Qumica S.A. de C.V. · 4 BOTTLE in 1 BOX / 4000 mL in 1 BOTTLE
This is a package of Solucion Antiseptica Dermoxine Solucion antiseptica topica a base de alcohol etilico .97 g/100mL; 70 mL/100mL Liquid from Key Qumica S.A. de C.V., marketed since Sep 2024 and currently FDA-listed.
NDC 58345-0106-04
🏷️ FDA NDC (as labeled)
58345-106-04
billing pads the product segment with a zero
This package
Contains4000 mL in 1 bottle
Pack sizes4 compare ↓
Product page 58345-0106-01
Also comes in:
3 bottles 58345-106-02
3 bottles 58345-106-03
12 bottles 58345-106-01
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
58345-106-04
Product NDC
58345-106
11-digit billing NDC
58345010604
UNII
MOR84MUD8E, 3K9958V90M
Application #
505G(a)(3)
SPL Set ID
226b154a-8e16-365a-e063-6394a90ae163
Physiologic effect
Decreased Cell Wall Integrity
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2024-09-18
Route
TOPICAL
Dosage form
LIQUID
Substance
CHLORHEXIDINE GLUCONATE; ALCOHOL
Why two NDCs?
The FDA registers this code as 58345-106-04 — 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 → 58345-0106-04. 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 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
🧪 What is this product?
Solucion Antiseptica Dermoxine is a topical liquid antiseptic intended for application to the skin. It contains alcohol and chlorhexidine gluconate, both of which are commonly used as antimicrobial agents in topical antiseptic products. This is an over-the-counter monograph drug, meaning it is marketed under established FDA guidelines for antiseptic products rather than as an individually approved application.
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 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about Solucion antiseptica topica a base de alcohol etilico?
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 mL | 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 3, 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 |
|---|---|---|---|---|
| 58345-0106-01 58345-106-01 Main listing | 12 BOTTLE, PUMP in 1 BOX / 500 mL in 1 BOTTLE, PUMP | 2024-09-18 | — | Active |
| 58345-0106-02 58345-106-02 | 3 BOTTLE in 1 BOX / 1000 mL in 1 BOTTLE | 2024-09-18 | — | Active |
| 58345-0106-03 58345-106-03 | 3 BOTTLE, PUMP in 1 BOX / 1000 mL in 1 BOTTLE, PUMP | 2024-09-18 | — | Active |
| 58345-0106-04 You're viewing this | 4 BOTTLE in 1 BOX / 4000 mL in 1 BOTTLE | 2024-09-18 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 4 bottle in 1 box / 4000 ml in 1 bottle.
What NDC number is used to bill for this package of Solucion Antiseptica Dermoxine Solucion antiseptica topica a base de alcohol etilico .97 g/100mL; 70 mL/100mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Solucion Antiseptica Dermoxine .97 g/100mL; 70 mL/100mLthis 58345-0106-04 | Key | 4 bottles | — | — | 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 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
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.
- FDA Orange Book · refreshed Sep 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII H4N855PNZ1
Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
-
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 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.
3 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesWater (aqua), moisturizers.
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 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 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
LabelerKey Qumica S.A. de C.V.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code58345
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio4 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.
- FDA openFDA NDC Directory · synced Oct 1, 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📋 Description
📄 Do Not Use
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Modo de empleo Directo. Después de un adecuado lavado de manos, aplique el producto sobre las mismas, frote suavemente durante 30 segundos mínimo abarcando toda la superficie (dorso, palmas y antebrazos) hasta que seque por completo. PARA MAYOR INFORMACIÓN CONSULTE LA FICHA TÉCNICA.
⏱️ Dosage and Administration ▾
Contenido de activos Alcohol Etílico, min 70.0 % v/v Gluconato de Clorhexidina 1.0 % Emolientes, min 0.5 % Agua c.b.p. 100 %
⚠️ Warnings ▾
Palabras de advertencia Atención
Indicaciones de peligro H226 - Líquido y vapores inflamables. H302 - Nocivo en caso de ingestión. H320 - Provoca irritación ocular. H335 - Puede irritar las vías respiratorias.
🧪 Active Ingredient ▾
Active ingredients Alcohol 70 % v/v Gluconato de Clorhexidina 1 %
🧪 Inactive Ingredients ▾
Inactive ingredients Water (aqua), moisturizers.
🎯 Purpose ▾
Purpose Antiseptic
📋 Description ▾
Descripción Antiséptico líquido para manos y piel, base Alcohol Etílico y Gluconato de Clorhexidina al 1 % de amplio espectro germicida. El mecanismo de acción de los activos presentes actúan de la siguiente forma: el alcohol modifica la presión osmótica de los microorganismos haciendo que entre una gran cantidad de líquido al interior de la célula, rompiendo la pared celular de los microorganismos. La Clorhexidina rompe la membrana citoplasmática haciendo que salgan los contenidos celulares de los mismos y por ende, mueran.
De esta manera se garantiza la reducción de la contaminación presente en la piel, sensacion de suciedad o grasa en las manos.
📄 Do Not Use ▾
Do not use Do not use this product in or near the eyes.
📄 Stop Use and Ask a Doctor If ▾
Stop use if irritation or redness develop. If contidions persist for more than 72 hours, consult a doctor.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, seek inmediate medical attention or call a poison center.
📄 Package Label / Principal Display Panel ▾
Dermoxine® Solución Antiséptica tópica a base de alcohol etílico Display 3 Display 4 Display 2 Display
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 ↗
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 Key Qumica S.A. de C.V.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 3 bottles (58345-0106-02), 3 bottles (58345-0106-03), 12 bottles (58345-0106-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Key Qumica S.A. de C.V. 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.