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DentiCalm Topical Analgesic 2 g/mL Emulsion, 1 applicator — NDC 82765-0002-00 package photo

DentiCalm Topical Analgesic 2 g/mL Emulsion, 1 applicator

by NFUSE LLC · 1 APPLICATOR in 1 PACKAGE (82765-0002-0) / .47 mL in 1 APPLICATOR (82765-0002-1)
NDC 82765-0002-00
🏷️ FDA NDC (as labeled) 82765-0002-0 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 82765-0002-0
Product NDC 82765-0002
11-digit billing NDC 82765000200
RxCUI 1146695
UNII L7T10EIP3A
Application # M017
SPL Set ID 414e6f6f-06bb-b470-e063-6294a90af390
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-01
Route TOPICAL
Dosage form EMULSION
Substance MENTHOL
Why two NDCs? The FDA registers this code as 82765-0002-0 — a 5-4-1 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 package segment → 82765-0002-00. 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.

🏭 Manufacturer & labeler

LabelerNFUSE LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code82765
First marketedFeb 2024
Product typeHuman Otc Drug
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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Menthol is found in a lot of over-the-counter topical products — creams, gels, patches, sprays, and powders. Depending on the product, it's used to temporarily ease minor muscle an...
  • Start with clean, dry skin — free of lotions or creams — before applying the patch. Peel the backing off and press the sticky side firmly to the sore area. Most menthol patches sho...
  • Yes, a mild burning or tingling feeling right after applying a menthol product is common and usually settles down within a few days of regular use. What's not normal is severe burn...
  • Is that burning sensation after I apply it normal?
📖 Read our full Menthol 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.

🧪 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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 55DGS3F5YG
    Arctium lappa root oil is a plant-derived oil extracted from burdock root. It's used in medicines as a natural emollient and conditioning agent to improve texture and skin feel in topical formulations.
  • UNII X7B7P649WQ
    A plant extract from boswellia serrata tree resin, used as a natural filler and binding agent in capsules and tablets to add bulk and help hold the formulation together.
  • UNII UPY805K99W
    A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
  • UNII S546YLW6E6
    Eucalyptus globulus leaf is a plant-derived ingredient that may serve as a flavoring agent or aromatic component in medications. It is commonly used to add taste or scent to oral formulations.
  • UNII 1Q953B4O4F
    Ilex paraguariensis leaf, commonly known as yerba mate, is a plant extract used in medicines as a flavoring agent and to add botanical content. It may also contribute mild preservative properties to the formulation.
  • UNII 02F3473H9O
    A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
  • UNII 4ERD2076EF
    A synthetic liquid made by combining polyethylene glycol with castor oil. It works as a solubilizer and emulsifier to help mix water and oil-based ingredients, keeping the medicine uniform throughout the product.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 8021PR16QO
    Theanine is an amino acid found naturally in tea leaves. In medications, it's typically used as an active ingredient for its potential calming effects, though it may also function as a flavor component or dietary supplement ingredient in some formulations.
  • UNII 9NP0832457
    A natural essential oil from the flowering parts of the mastich thyme plant. It serves as a fragrance and flavoring agent to improve the taste and smell of the medicine.
  • 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.

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

The official label also statesWater, Magnesium Chloride USP, Propanediol, PEG-40 Hydrogenated Castor Oil, L-Theanine, Eucalyptus Globulus Leaf Oil, Aloe Barbadensis Leaf Extract, Ilex Paraguariensis Leaf Extract, Boswellia Serrata Oil, Arctium Lappa Root Extract, Thymus Mastichina Flower Oil, 1,2-Hexanediol, Caprylhydroxamic Acid

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Therapain Plus 2 g/100mL 58418-0827-03 Epic 88.5 ml — — FDA listed —
DentiCalm 2 g/mLthis 82765-0002-00 NFUSE 1 applicator — — 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
Feb 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.

🔬 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 DentiCalm (this brand).

Top reported reactions

Retinal Pigment Epithelial Tear3
Chemical Burn Of Skin1
Myocardial Infarction1

Reporter sex

5 reports
Male · 100%
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
82765-0002-00 You're viewing this 1 APPLICATOR in 1 PACKAGE (82765-0002-0) / .47 mL in 1 APPLICATOR (82765-0002-1) 2024-02-01 Active

🧭 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 FDA registers it as 82765-0002-0, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 82765-0002-00, written without dashes as 82765000200. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 82765-0002-00, the first segment (82765) is the labeler code FDA assigned to NFUSE LLC; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
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 NFUSE LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NFUSE 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.

📄 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
🎯 Indications and Usage 20 words ▾

Usage Temporary relief from minor aches and pains of sore muscles and joints associated with teeth grinding and clenching (bruxism)

⏱️ Dosage and Administration 36 words ▾

Dosage & Admnistration Shake before use. Adults and children 12 years of age and older: apply over affected areas not more than four times daily; massage as necessary. Children under 12 years of age: Consult physician.

⚠️ Warnings 80 words ▾

Warnings For External Use Only When using this product: [bullet] Avoid contact with eyes and mucous membranes [bullet] Do not apply to wounds or broken skin [bullet] Do not bandage [bullet] Do not apply to irritated skin or if excessive skin irritation develops Stop use and ask a doctor if conditions worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

🧪 Active Ingredient 7 words ▾

Active Ingredient Menthol 2% Purpose: Topical Analgesic

🧪 Inactive Ingredients 38 words ▾

Inactive Ingredients Water, Magnesium Chloride USP, Propanediol, PEG-40 Hydrogenated Castor Oil, L-Theanine, Eucalyptus Globulus Leaf Oil, Aloe Barbadensis Leaf Extract, Ilex Paraguariensis Leaf Extract, Boswellia Serrata Oil, Arctium Lappa Root Extract, Thymus Mastichina Flower Oil, 1,2-Hexanediol, Caprylhydroxamic Acid

🎯 Purpose 4 words ▾

Purpose Purpose: Topical Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 82761-0056-60 · Laura 82775-0100-01 · POLPHARMA →
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.