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Dermoplast First Aid BENZETHONIUM CHLORIDE and BENZOCAINE 2 mg/g; 200 mg/g Spray, 78 g — NDC 16864-0670-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dermoplast First Aid BENZETHONIUM CHLORIDE and BENZOCAINE 2 mg/g; 200 mg/g Spray, 78 g — NDC 16864-670-01 (Billing 16864-0670-01)

by Advantice Health, LLC · 78 g in 1 CAN

This is a package of 78 g of Dermoplast First Aid BENZETHONIUM CHLORIDE and BENZOCAINE 2 mg/g; 200 mg/g Spray from Advantice Health, LLC, marketed since Jan 2010 and currently FDA-listed. It is this product's only package size.

NDC 16864-0670-01
🏷️ FDA NDC (as labeled) 16864-670-01 billing pads the product segment with a zero
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

Past resolved recalls for this product (1)
Class III · Feb 2, 2023 · Terminated — Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing. (Advantice Health, Llc) · FDA recall D-0329-2023

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 16864-670-01
Product NDC 16864-670
11-digit billing NDC 16864067001
NCPDP billing unit GM — per gram (weight)
RxCUI 1049108, 1101914
UNII PH41D05744, U3RSY48JW5
Application # M003
SPL Set ID ec93011d-7069-4021-8dd2-3d51eb6026e1
Established class (EPC) Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-01-01
Route TOPICAL
Dosage form SPRAY
Substance BENZETHONIUM CHLORIDE; BENZOCAINE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 058845
GCN 24366
HICL code 000338
Ingredient (HICL) Benzocaine/Benzethon Cl
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 Q5H
Therapeutic class — specific (HIC3) Topical Local Anesthetics
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name DERMOPLAST FIRST AID SPRAY
FDB brand name Dermoplast
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 058845
  • GCN: 24366
  • HICL (First Databank): 000338
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 1049108
Why two NDCs? The FDA registers this code as 16864-670-01 — 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 → 16864-0670-01. 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 Antiseptics class.

Drug family (ATC) Antiseptics, Quaternary ammonium compounds
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.

Clinical

Label name DERMOPLAST FIRST AID SPRAY Ingredient Benzocaine/Benzethon Cl
🧪 What is this product?

Dermoplast First Aid is a topical spray containing benzocaine and benzethonium chloride. Benzocaine is a local anesthetic typically used to numb minor pain and discomfort on the skin surface, while benzethonium chloride functions as an antimicrobial agent commonly used to help reduce bacteria. This product is marketed as an over-the-counter monograph drug, meaning it follows established FDA guidelines for its category rather than being individually reviewed for approval.

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 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
16864-0670-01 You're viewing this Main listing 78 g in 1 CAN 2010-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dermoplast First Aid 2 mg/g; 200 mg/gthis 16864-0670-01 Advantice 78 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

🏛️
2010
On the market since
Jan 2010
📍
2026
Currently FDA-listed
16 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.

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

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • 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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII NMQ347994Z
    Cyclomethicone is a silicone-based fluid that acts as a lubricant and solvent in medicines. It helps products flow smoothly, reduces friction between particles, and aids in even distribution of active ingredients.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII BXR49TP611
    Isobutane is a liquefied gas used as a propellant in aerosol inhalers and sprays. It helps push the medicine out of the container so you can breathe or spray it as directed.

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

The official label also statesaloe vera gel (decolorized), cyclomethicone, dipropylene glycol, isobutane, SD alcohol 40-B (73% v/v), tocopheryl acetate (vitamin E acetate)

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

LabelerAdvantice Health, LLC
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code16864
First marketedJan 2010
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.

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

Uses first aid for the temporary relief of pain and itching and to help prevent infection in minor cuts, scrapes and burns

⏱️ Dosage and Administration 74 words ▾

Directions clean the affected area Adults and children 2 years of age and older apply a small amount to affected area 1 to 3 times daily Children under 2 years of age consult a doctor to use this product, hold the can 6 to 12 inches away from the affected area. Direct spray nozzle towards skin and press button to activate spray. to apply to face, spray in palm of hand and gently apply

⚠️ Warnings 171 words ▾

Warnings For external use only Flammable do not use near heat, flame, or fire or while smoking Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. Do not use in the eyes over large areas of the body When using this product avoid contact with eyes. Do not spray in the face or mouth. use only as directed intentional misuse by deliberately concentrating or inhaling the contents can be harmful or fatal do not puncture or incinerate.

Contents under pressure. Do not store at temperatures above 120°F. Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days itching, rash or irritation develops Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 20 words ▾

Other information avoid contact with leather, fabric and upholstery to prevent possible staining or discoloration store at 20-25°C (68-77° F)

🧪 Active Ingredient 13 words ▾

Active ingredients Purposes Benzethonium chloride 0.2% First aid antiseptic Benzocaine 20% Topical analgesic

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients aloe vera gel (decolorized), cyclomethicone, dipropylene glycol, isobutane, SD alcohol 40-B (73% v/v), tocopheryl acetate (vitamin E acetate)

🎯 Purpose 13 words ▾

Active ingredients Purposes Benzethonium chloride 0.2% First aid antiseptic Benzocaine 20% Topical analgesic

📄 Do Not Use 12 words ▾

Do not use in the eyes over large areas of the body

📄 Ask a Doctor Before Use If 16 words ▾

Ask a doctor before use if you have deep or puncture wounds animal bites serious burns

📄 When Using This Product 49 words ▾

When using this product avoid contact with eyes. Do not spray in the face or mouth. use only as directed intentional misuse by deliberately concentrating or inhaling the contents can be harmful or fatal do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

📄 Stop Use and Ask a Doctor If 32 words ▾

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days itching, rash or irritation develops

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 9 words ▾

Questions? 1-800-345-0032 Mon - Fri 8AM- 5PM EST Dermoplast.com

📄 Package Label / Principal Display Panel 61 words ▾

PRINCIPAL DISPLAY PANEL - 78 g Can Label Dermoplast ® Antiseptic & Pain Relieving Spray HOSPITAL STRENGTH FIRST AID ANTIBACTERIAL SPRAY KILLS 99% OF GERMS To Prevent Infection For Minor Cuts, Scrapes & Burns Disinfects Burns & Wounds Provides Fast Pain Relief Soothing Aloe & Vitamin E NET WT. 2.75 oz (78 g) PRINCIPAL DISPLAY PANEL - 78 g Can Label

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 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.
← 16864-0660-01 · Advantice 16864-0680-01 · 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.