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Gel Antiseptico Dermowipe Gel antiseptico a base de alcohol etilico 70 mL/70mL Gel — NDC 58345-103-05 (Billing 58345-0103-05)

by Key Qumica S.A. de C.V. · 4 BOTTLE in 1 BOX / 4000 mL in 1 BOTTLE

This is a package of Gel Antiseptico Dermowipe Gel antiseptico a base de alcohol etilico 70 mL/70mL Gel from Key Qumica S.A. de C.V., marketed since Apr 2024 and currently FDA-listed.

NDC 58345-0103-05
🏷️ FDA NDC (as labeled) 58345-103-05 billing pads the product segment with a zero
This package
Contains4000 mL in 1 bottle Pack sizes8 compare ↓
Product page 58345-0103-01 Also comes in: 2 bottles 58345-103-08 3 bottles 58345-103-04 3 bottles 58345-103-07 6 bottles 58345-103-02 12 bottles 58345-103-01 800 ml 58345-103-03 20000 ml 58345-103-06
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58345-103-05
Product NDC 58345-103
11-digit billing NDC 58345010305
UNII 3K9958V90M
UPC 7503030886277
Application # 505G(a)(3)
SPL Set ID 15620afc-d6ae-0f34-e063-6294a90a8ad2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-05
Route TOPICAL
Dosage form GEL
Substance ALCOHOL
Why two NDCs? The FDA registers this code as 58345-103-05 — 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 → 58345-0103-05. 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

📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Hand sanitizers and wipes help reduce bacteria on your skin, and alcohol pads prepare skin before an injection. A separate injected form is used by heart...
  • Most directions say to cover all surfaces of your hands and rub until dry. Sprays and wipes follow similar steps. Check your product's label, since directions differ a bit between...
  • Children under 6 should use hand sanitizer only with adult supervision to avoid swallowing. Keep all products out of reach of children. If someone swallows it, get medical help or...
  • Stop using it and ask a doctor if you get irritation and redness, or if your condition lasts more than 72 hours. Avoid broken skin and keep it out of your eyes. If it gets in your...
📖 Read our full Alcohol 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.

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.
Try another pack size: 2 bottles 3 bottles 3 bottles 6 bottles 12 bottles 800 ml 20000 ml
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
58345-0103-01 58345-103-01 Main listing 12 BOTTLE, PUMP in 1 BOX / 300 mL in 1 BOTTLE, PUMP 2024-04-05 — Active
58345-0103-02 58345-103-02 6 BOTTLE, PUMP in 1 BOX / 960 mL in 1 BOTTLE, PUMP 2024-04-05 — Active
58345-0103-03 58345-103-03 6 BAG in 1 BOX / 800 mL in 1 BAG 2024-04-05 — Active
58345-0103-04 58345-103-04 3 BOTTLE in 1 BOX / 1000 mL in 1 BOTTLE 2024-04-05 — Active
58345-0103-05 You're viewing this 4 BOTTLE in 1 BOX / 4000 mL in 1 BOTTLE 2024-04-05 — Active
58345-0103-06 58345-103-06 20000 mL in 1 BOTTLE 2024-04-05 — Active
58345-0103-07 58345-103-07 3 BOTTLE, PUMP in 1 BOX / 1000 mL in 1 BOTTLE, PUMP 2024-04-05 — Active
58345-0103-08 58345-103-08 2 BOTTLE, PUMP in 1 BOX / 4000 mL in 1 BOTTLE, PUMP 2024-04-05 — 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 Gel Antiseptico Dermowipe Gel antiseptico a base de alcohol etilico 70 mL/70mL Gel?
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gel Antiseptico Dermowipe 70 mL/70mLthis 58345-0103-05 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.

Availability & generic status

🏛️
2024
On the market since
Apr 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerKey Qumica S.A. de C.V.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code58345
First marketedApr 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 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 28 words ▾

Modo de empleo Uso directo. Aplique el producto en la superficie de sus manos, frote suavemente durante 30 segundos mínimo, y/o hasta que el producto seque por completo.

⏱️ Dosage and Administration 24 words ▾

Contenido de activos Alcohol etílico mín. 70.0 % Humectantes mín. 1.0 % Aditivos mín. 0.5 % Fragancia mín. 0.1 % Agua c.b.p. 100.00 %

⚠️ Warnings 37 words ▾

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. Display Contenido de activos Descripción

🧪 Active Ingredient 6 words ▾

Active ingredient Acohol 70 % v/v

🧪 Inactive Ingredients 12 words ▾

Inactive ingredients Water (aqua), Glycerin, Carbopol, Triethanolamine, Fragance, Glycereth-7 triacetate and Tocopherol.

🎯 Purpose 2 words ▾

Purpose Antiseptic

📋 Description 60 words ▾

Descripción Actúa modificando la presión osmótica de los microorganis- mos haciendo que penetre una gran cantidad de líquido rompiéndose la pared de la membrana celular, de esta manera el producto actúa como germicida reduciendo la contaminación presente en la piel. Efectivo en la reducción en 30 seg. de Staphlylococcus aureus y Escherichia coli. Descripción Consejos de prudencia Palabras de advertencia

📄 Do Not Use 13 words ▾

Do not use Do not use this product in or near the eyes.

📄 Stop Use and Ask a Doctor If 18 words ▾

Stop use if irritation or redness develop. If conditions persist for more than 72 hours, consult a doctor.

📄 Keep Out of Reach of Children 18 words ▾

Keep out of reach of children. If swallowed, seek inmediate medical attention or call a poison control center.

📄 Package Label / Principal Display Panel 13 words ▾

Dermowipe® Gel antiséptico tópico a base de alcohol etílico Indicaciones de peligro Extra

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 7 other package presentations of this same product, including 2 bottles (58345-0103-08), 3 bottles (58345-0103-04), 3 bottles (58345-0103-07). 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.
← 58343-0140-00 · Synthokem 58345-0104-01 · Key →
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.