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Nuvira Capsaicin 0.025%, Menthol 10%, Methyl Nicotinate 0.25%, Methyl Salicylate 10% .0025 g/g; .1 g/g; .00025 g/g; .1 g/g Patch, 30 patches — NDC 83295-3313-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nuvira Capsaicin 0.025%, Menthol 10%, Methyl Nicotinate 0.25%, Methyl Salicylate 10% .0025 g/g; .1 g/g; .00025 g/g; .1 g/g Patch, 30 patches — NDC 83295-3313-1 (Billing 83295-3313-01)

by Strand Health Group · 6 POUCH in 1 BOX / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH

This is a package of 30 patches of Nuvira Capsaicin 0.025%, Menthol 10%, Methyl Nicotinate 0.25%, Methyl Salicylate 10% .0025 g/g; .1 g/g; .00025 g/g; .1 g/g Patch from Strand Health Group, marketed since Jun 2023 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 83295-3313-01
🏷️ FDA NDC (as labeled) 83295-3313-1 billing pads the package segment with a zero
This package
Contains30 patches Pack sizes2 compare ↓
Main listing for product 83295-3313 · Also comes in: 5 patches 83295-3313-5
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 83295-3313-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83295 labeler · 3313 product · 1 package
Package marketed since
Jun 29, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
30 EA per package
Barcode (UPC-A, from the NDC)
3 8329533131 9
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83295-3313-1
Product NDC 83295-3313
11-digit billing NDC 83295331301
NCPDP billing unit EA — each (per item)
RxCUI 2640874
UNII 7B1AVU9DJN, LAV5U5022Y, S07O44R1ZM, L7T10EIP3A
Application # M017
SPL Set ID ff448183-03cf-df2d-e053-6394a90a77f0
Established class (EPC) Nicotinic Acid
Chemical class Nicotinic Acids
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-06-29
Route CUTANEOUS
Dosage form PATCH
Substance METHYL NICOTINATE; METHYL SALICYLATE; CAPSAICIN; MENTHOL

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

GCN Seq No 085233
GCN 54657
HICL code 049185
Ingredient (HICL) Capsaic/M.nicot/M.salic/Menth
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L6
Therapeutic class — intermediate (HIC2) Irritants
HIC3 code L6A
Therapeutic class — specific (HIC3) Irritants/Counter-Irritants
AHFS code 84:92.00.00
AHFS class Skin And Mucous Membrane Agents, Misc.
FDB label name NUVIRA 0.025-10-0.25-10% PATCH
FDB brand name Nuvira
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 085233
  • GCN: 54657
  • HICL (First Databank): 049185
  • AHFS class code: 84:92.00.00
  • RxCUI (RxNorm): 2640874
Why two NDCs? The FDA registers this code as 83295-3313-1 — 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 → 83295-3313-01. 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 Capsaicin and similar agents class.

Drug family (ATC) Capsaicin and similar agents, Other local anesthetics
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 NUVIRA 0.025-10-0.25-10% PATCH Ingredient Capsaic/M.nicot/M.salic/Menth
🧪 What is this product?

Nuvira is a topical patch product sold over the counter under FDA's OTC monograph rules. It contains four active ingredients that are commonly used together to produce a warming or cooling sensation on the skin: capsaicin (a compound from peppers), menthol, methyl nicotinate, and methyl salicylate. These ingredients are typically found in products intended for temporary comfort relief when applied to the skin surface.

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 eachPer 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: 5 patches
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
83295-3313-01 You're viewing this Main listing 6 POUCH in 1 BOX / 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH 2023-06-29 — Active
83295-3313-05 83295-3313-5 5 PATCH in 1 POUCH / 8.5 g in 1 PATCH 2023-06-29 — Active

Pack size FAQ

What quantity is in this package?
This package contains 30 patches — 6 pouch in 1 box / 5 patch in 1 pouch / 8.5 g in 1 patch.
How does this package differ from NDC 83295-3313-05?
Both are Nuvira Capsaicin 0.025%, Menthol 10%, Methyl Nicotinate 0.25%, Methyl Salicylate 10% .0025 g/g; .1 g/g; .00025 g/g; .1 g/g Patch — the drug itself is identical. This page's package is the 30 patches one, while NDC 83295-3313-05 is the 5 patches package.
What NDC number is used to bill for this package of Nuvira Capsaicin 0.025%, Menthol 10%, Methyl Nicotinate 0.25%, Methyl Salicylate 10% .0025 g/g; .1 g/g; .00025 g/g; .1 g/g Patch?
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
Nuvira .0025 g/g; .1 g/g; .00025 g/g; .1 g/gthis 83295-3313-01 Strand 30 patches — — 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

🏛️
2023
On the market since
Jun 2023
📍
2026
Currently FDA-listed
3 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 66YXD4DKO9
    A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
  • 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 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 OZ0E5Y15PZ
    A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII DO250MG0W6
    A mineral compound containing aluminum that acts as an antacid and buffering agent. It helps neutralize stomach acid and is used as a pH buffer to stabilize the medicine's formulation.
  • UNII 9H4PO4Z4FT
    A sulfur-containing organic compound used as a solvent and penetration enhancer in medicines. It helps dissolve active ingredients and improve their absorption through skin or mucous membranes.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII R9XLF1R1WM
    Frankincense is a natural resin from the Boswellia tree. It's used in medicines as a binder or thickener to help hold ingredients together and improve the product's consistency and texture.
  • 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 ET5GD00TRP
    A natural oil extracted from lemon peel used as a flavoring agent and fragrance in medicines. It masks bitter tastes and adds pleasant lemon flavor to make medications easier to take.
  • 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 9G2MAD7J6W
    Polyacrylic acid is a synthetic polymer used as a binder and thickening agent in medicines. It helps hold tablet ingredients together and can increase the viscosity of liquid or semi-solid formulations.
  • UNII 05I15JNI2J
    A synthetic polymer that absorbs and holds moisture. Used in tablets and capsules as a super-disintegrant to help the medicine break apart quickly when swallowed, allowing faster drug release.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.

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

The official label also statesAloe Vera Gel, Arnica, Boswellia, Citris Limon (Lemon Oil), Dihydroxyaluminum Aminoacetate, Dimethyl Sulfone (DMSO2), Eucalyptus Oil, Glycerol, Methylparaben, Polyacrylic Acid, Prunis Amygdalus Dulcis (Almond Oil), Pure Water, Sodium Polyacrylate, Sorbitol, Vitamin C, Vitamin E.

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

LabelerStrand Health Group
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code83295
First marketedJun 2023
Product typeHuman Otc Drug
Portfolio6 products on file

More NDCs from Strand Health Group labeler code 83295

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 35 words ▾

Uses For the temporary relief of joint pain, muscle pain, and inflammation associated with: Arthritis Backache Discomfort Cramps Neckache Soreness Sprains Strains This product may take up to 7 days to work for arthritis pain.

⏱️ Dosage and Administration 57 words ▾

Directions Adults and Children 12 Years of Age and Older: Clean and dry the affected area Apply gel pad directly to your skin for up to 12 hours Gel pad can be cut into pieces and used on up to 2 body parts at a time One application per day is recommended Wash hands immediately after use

⚠️ Warnings 195 words ▾

Warnings For External Use Only Topical use only Allergy Alert : NSAIDs may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: Hives Asthma (wheezing) Skin Reddening Blisters Facial Swelling Shock Rash If an allergic reaction occurs, stop use and seek medical attention immediately. Liver Warning : This product contains an NSAID.

Liver damage may occur if you apply (1) more or for a longer time than directed or (2) when using other drugs containing an NSAID. Stomach Bleeding Warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is small, but higher if you: Are age 60 or older Have had stomach ulcers or bleeding problems Take a blood thinning (anticoagulant) or steroid drug Take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen or others) Have 3 or more alcoholic drinks every day while using this product Apply more or for longer than directed Heart Attack and Stroke Warning : NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke.

These can be fatal. The risk is higher if you use more than directed or for longer than directed.

🧪 Active Ingredient 13 words ▾

Active Ingredients Capsaicin 0.025% Menthol 10% Methyl Nicotinate 0.25% Methyl Salicylate 10% (NSAID)

🧪 Inactive Ingredients 36 words ▾

Inactive Ingredients Aloe Vera Gel, Arnica, Boswellia, Citris Limon (Lemon Oil), Dihydroxyaluminum Aminoacetate, Dimethyl Sulfone (DMSO2), Eucalyptus Oil, Glycerol, Methylparaben, Polyacrylic Acid, Prunis Amygdalus Dulcis (Almond Oil), Pure Water, Sodium Polyacrylate, Sorbitol, Vitamin C, Vitamin E.

🎯 Purpose 5 words ▾

Purpose Counterirritant Counterirritant Counterirritant Counterirritant

📄 Do Not Use 40 words ▾

Do Not Use On damaged, irritated, or infected skin With a bandage or heating pad If you are allergic to any ingredients in this product Right before or after heart surgery In the eyes, nose, or mouth Otherwise as directed

📄 When Using This Product 12 words ▾

When Using This Product Avoid contact with the eyes and mucous membranes

📄 Stop Use and Ask a Doctor If 64 words ▾

Stop Use and Ask a Doctor If Any of the Warnings apply to you You are taking a diuretic You are taking any other drugs You have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke Excessive skin irritation develops Condition worsens Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days

🤰 If Pregnant or Breast-Feeding 33 words ▾

If Pregnant or Breast-Feeding Ask a health professional before use. It is especially important not to use NSAIDs at 20 weeks or later in pregnancy, unless directed by a doctor to do so.

📄 Keep Out of Reach of Children 18 words ▾

Keep Out of Reach of Children If ingested seek medical help or contact a Poison Control Center immediately

📄 Questions or Comments 4 words ▾

Questions or Comments? [email protected]

📄 Package Label / Principal Display Panel 5 words ▾

Principal Display Panel box pouch

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Nuvira (this brand).

Top reported reactions

Chemical Burn Of Skin1
Scar1

Reporter sex

1 reports
Female · 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.

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 Strand Health Group. 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 1 other package presentation of this same product, including 5 patches (83295-3313-05). 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?
Strand Health Group 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.
← 83294-0101-18 · CLEURE 83295-4000-01 · Strand →
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.