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Dermoplast Pain Relieving BENZOCAINE and LEVOMENTHOL 200 mg/g; 5 mg/g Spray, 78 g — NDC 16864-0680-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dermoplast Pain Relieving BENZOCAINE and LEVOMENTHOL 200 mg/g; 5 mg/g Spray, 78 g — NDC 16864-680-01 (Billing 16864-0680-01)

by Advantice Health, LLC · 78 g in 1 CAN

This is a package of 78 g of Dermoplast Pain Relieving BENZOCAINE and LEVOMENTHOL 200 mg/g; 5 mg/g Spray from Advantice Health, LLC, marketed since Jan 2014 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 16864-0680-01
🏷️ FDA NDC (as labeled) 16864-680-01 billing pads the product segment with a zero
This package
Contains78 g Pack sizes3 compare ↓
Main listing for product 16864-680 · Also comes in: 56 g 16864-680-02 85 g 16864-680-03
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) 16864-680-01
Product NDC 16864-680
11-digit billing NDC 16864068001
NCPDP billing unit GM — per gram (weight)
RxCUI 199864, 763484
UNII U3RSY48JW5, BZ1R15MTK7
Application # M017
SPL Set ID 2347f0b8-d463-422d-8583-65624d9a1a91
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 2014-01-01
Route TOPICAL
Dosage form SPRAY
Substance BENZOCAINE; LEVOMENTHOL

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

GPI-14 90859902453220
GPI class Dermoplast
GCN Seq No 067995
GCN 30671
HICL code 001675
Ingredient (HICL) Benzocaine/Menthol
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 PAIN RELIEVING SPRY
FDB brand name Dermoplast
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 067995
  • GCN: 30671
  • GPI-14 (Medi-Span): 90859902453220
  • HICL (First Databank): 001675
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 199864
Why two NDCs? The FDA registers this code as 16864-680-01 — 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 → 16864-0680-01. 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 Standardized Chemical Allergen class.

Pharmacologic class Standardized Chemical Allergen
Drug family (ATC) Local anesthetics, Anesthetics for topical use, Esters of aminobenzoic acid
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 PAIN RELIEVING SPRY Ingredient Benzocaine/Menthol
📖 About the active ingredient: Benzocaine; Levomenthol MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Benzocaine and menthol topical is used to relieve pain and itching on the skin. Benzocaine and menthol are in a class of medications called topical analgesics. It works by blocking pain signals to the brain from an area of skin.

Read the full MedlinePlus article ↗
🧪 What is this product?

Dermoplast Pain Relieving is a topical spray marketed as an over-the-counter monograph product. It contains benzocaine, a local anesthetic, and levomenthol, a cooling agent derived from mint. These ingredients are typically used together in products meant to temporarily numb and cool minor skin discomfort, such as pain from minor burns, cuts, or insect bites.

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.
Try another pack size: 56 g 85 g
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
16864-0680-01 You're viewing this Main listing 78 g in 1 CAN 2014-01-01 — Active
16864-0680-02 16864-680-02 56 g in 1 CAN 2014-01-01 — Discontinued by firm
16864-0680-03 16864-680-03 85 g in 1 CAN 2014-01-01 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 78 g — 78 g in 1 can.
How does this package differ from NDC 16864-0680-02?
Both are Dermoplast Pain Relieving BENZOCAINE and LEVOMENTHOL 200 mg/g; 5 mg/g Spray — the drug itself is identical. This page's package is the 78 g one, while NDC 16864-0680-02 is the 56 g package.
What NDC number is used to bill for this package of Dermoplast Pain Relieving BENZOCAINE and LEVOMENTHOL 200 mg/g; 5 mg/g Spray?
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
Walgreens Pain Burn Itch Relief 5 mg/g; 200 mg/g 00363-2053-02 Walgreens 78 g — — FDA listed —
Rite Aid Pain Relieving 20 g/100g; .5 g/100g 11822-1343-03 Rite 85 g — — FDA listed —
Dermoplast Pain Relieving 200 mg/g; 5 mg/gthis 16864-0680-01 Advantice 78 g — — FDA listed —
Dermoplast Pain relieving 200 mg/g; 5 mg/g 16864-0690-01 Advantice 78 g — — FDA listed —
Pain, Burn, and Itch Relief 20 g/100g; .5 g/100g 72839-0343-03 Derma 85 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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 0B1U8K2ME0
    A synthetic gas used as a propellant in pressurized aerosol inhalers. It helps deliver the active medication as a fine mist or spray into the lungs or airways.
  • UNII SNN716810P
    A waxy substance derived from lanolin, an oil from sheep's wool, that has been chemically modified. It acts as an emulsifier and thickener to help blend water and oil-based ingredients together and improve texture.
  • 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 6LV4FOR43R
    Butane is a colorless gas derived from petroleum. In medicines, it serves as a propellant in inhalers and aerosol sprays, helping deliver the active drug to the lungs or skin.
  • UNII 4Q43814HXS
    Cetyl acetate is a waxy compound made by combining cetyl alcohol with acetic acid. It works as a binder and thickener in medicines, helping to hold ingredients together and give the product a smooth, creamy texture.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 762O8IWA10
    PEG-8 laurate is a synthetic compound made by combining polyethylene glycol with lauric acid. It acts as an emulsifier and solubilizer in medicines, helping to blend water and oil-based ingredients together and improve how well some drugs dissolve.
  • UNII A7F3N56197
    Polysorbate 85 is a man-made emulsifier and solubilizer derived from sorbitol and oleic acid. It helps keep oils and water mixed together in liquid medicines and allows poorly soluble ingredients to dissolve evenly throughout the formulation.

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

The official label also statesacetylated lanolin alcohol, aloe vera gel (decolorized), butane, cetyl acetate, hydrofluorocarbon 152a, methylparaben, PEG-400 monolaurate, polysorbate 85

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 applicationM017 (OTC MONOGRAPH DRUG)
Labeler code16864
First marketedJan 2014
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
🎯 Indications and Usage 21 words ▾

Uses for temporary relief of pain and itching associated with sunburn insect bites minor cuts scrapes minor burns minor skin irritations

⏱️ Dosage and Administration 70 words ▾

Directions Adults and children 2 years of age and older apply to affected area not more than 3 to 4 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 143 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. 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 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 19 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 11 words ▾

Active ingredients Purpose Benzocaine 20% Topical analgesic Menthol 0.5% Topical analgesic

🧪 Inactive Ingredients 19 words ▾

Inactive ingredients acetylated lanolin alcohol, aloe vera gel (decolorized), butane, cetyl acetate, hydrofluorocarbon 152a, methylparaben, PEG-400 monolaurate, polysorbate 85

🎯 Purpose 11 words ▾

Active ingredients Purpose Benzocaine 20% Topical analgesic Menthol 0.5% Topical analgesic

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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 56 g (16864-0680-02), 85 g (16864-0680-03). 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?
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.
← 16864-0670-01 · Advantice 16864-0690-01 · 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.