Home › NDC Lookup › Ingredients › Capsaicin, Menthol › 83676-0435-00
PURE EASE Joint Muscle lnstant Pain Relief CAPSAICIN, MENTHOL .25 mg/mL; 80 mg/mL Cream, 60 mL — NDC 83676-0435-00 package photo

PURE EASE Joint Muscle lnstant Pain Relief CAPSAICIN, MENTHOL .25 mg/mL; 80 mg/mL Cream, 60 mL

by SERENU, INC. · 60 mL in 1 JAR (83676-435-00)
NDC 83676-0435-00
🏷️ FDA NDC (as labeled) 83676-435-00 billing pads the product 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) 83676-435-00
Product NDC 83676-435
11-digit billing NDC 83676043500
UNII S07O44R1ZM, L7T10EIP3A
UPC 9145550944204
Application # M017
SPL Set ID 42bf129c-5c84-4331-b6d0-78e3be71a985
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-11-27
Route TOPICAL
Dosage form CREAM
Substance CAPSAICIN; MENTHOL
Why two NDCs? The FDA registers this code as 83676-435-00 — 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 → 83676-0435-00. 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

LabelerSERENU, INC.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code83676
First marketedNov 2023
Product typeHuman Otc Drug
Portfolio2 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.

🩺 Clinical

🧪 What is this product?

Pure Ease Joint Muscle Instant Pain Relief is a topical cream marketed as an over-the-counter monograph product. It contains capsaicin and menthol, two ingredients commonly used in topical pain-relief preparations. Capsaicin, derived from chili peppers, and menthol are typically applied to the skin over sore joints and muscles to produce a warming or cooling sensation that may help reduce discomfort. This product is applied directly to the affected area rather than taken by mouth.

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 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical 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 F7LTH1E20Y
    Arginine hydrochloride is an amino acid salt used as a buffer and pH adjuster in medicines. It helps maintain the correct acidity level to keep the drug stable and effective.
  • 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 69VJ1LPN1S
    Cannabis sativa seed oil is a plant-based oil derived from hemp seeds. It's used in medicines as a carrier or emollient to help deliver active ingredients and improve product texture and absorption.
  • UNII 58B69Q84JO
    A plant-derived emulsifier made from olive oil and fatty alcohols. It helps blend oil and water ingredients together and stabilizes the product's texture in creams, lotions, and similar formulations.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 0N8672707O
    A starch derived from corn kernels. It acts as a binder to hold tablet ingredients together, a filler to give the tablet bulk, and a disintegrant to help the tablet break apart in your stomach.
  • UNII P6YC3EG204
    Cyanocobalamin is a synthetic form of vitamin B12. It's used in medicines as a nutritional ingredient and to help maintain the product's stability and potency over time.
  • 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 344821WD61
    Emu oil is a natural fat derived from emu birds, used in some medicines as an emollient and penetration enhancer to help active ingredients absorb through the skin and soften the formulation.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII C5529G5JPQ
    Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
  • 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 258491E1RZ
    A waxy substance made from glycerin and stearic acid, commonly used as an emulsifier to help blend oil and water ingredients together in medicines. It also helps thicken and stabilize the product's texture.
  • UNII 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII BKJ0J3D1BP
    A plant-derived ingredient from sunflower flowers, used as a natural colorant and flavoring agent in medicines. It may help provide color or mild taste to the product.
  • UNII TD1MUT01Q7
    Hemp is a plant-derived ingredient used as a binder or filler in solid dosage forms like tablets and capsules. It helps hold other ingredients together and adds bulk to the medicine.
  • UNII 4PW41QCO2M
    Indian frankincense is a natural resin extracted from trees native to India. It is used in medicines as a binder and thickening agent to help hold ingredients together and improve texture.
  • UNII 0R822556M5
    A stabilized form of vitamin C derived from ascorbic acid and magnesium. It's used as an antioxidant and preservative to prevent ingredient degradation and extend shelf life in medications and supplements.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII LAV5U5022Y
    Methyl salicylate is a naturally derived liquid compound commonly found in wintergreen plants. In medicines, it's used as a flavoring agent and penetrating solvent to help distribute active ingredients evenly throughout topical products.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII AZC253V6FB
    A synthetic polymer used as a binder and disintegrant to help hold tablet ingredients together and allow the tablet to break apart properly when swallowed.
  • UNII 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAllantoin, Aloe Barbadnesis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), L-Arginine-Monohydrochloride, HCL, Amica Montana Flower Extract, Ascorbyl Phosphate (Liposomal Vitamin C), Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cannabis Saliva (Hemp) Seed Oil, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cyanocobalamin (Vitamin B12), Emu Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Ilex Paraquariensis (Verba Mate') Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Phospholipids, Sorbitan Olivate, Stearic Acid, Urea, Xanthan Gum, Zemea (Com) Propanediol, Zingiber Officinalis (Ginger) Extract.

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 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.
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
PURE EASE Joint Muscle lnstant Pain Relief .25 mg/mL; 80 mg/mLthis 83676-0435-00 SERENU, 60 ml — — FDA listed —
PURE EASE Neur Cream Instant Deep Pain Relief .25 mg/mL; 80 mg/mL 83676-0436-00 SERENU, 60 ml — — 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
Nov 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.

🔬 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 CAPSAICIN, MENTHOL — the ingredient across all brands.

Top reported reactions

Fatigue59
Pain57
Diarrhoea47
Fall45
Arthralgia44
Headache43
Pain In Extremity39

Age at onset

Adult24
Elderly41

Reporter sex

582 reports
Male · 21%
Female · 79%

Serious outcomes

Hospitalization135
Death29
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 50 0
Most recent year is provisional (FAERS lags ~3 months).
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
83676-0435-00 You're viewing this 60 mL in 1 JAR (83676-435-00) 2023-11-27 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 83676-435-00, 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: 83676-0435-00, written without dashes as 83676043500. 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 83676-0435-00, the first segment (83676) is the labeler code FDA assigned to SERENU, INC.; the middle segment (0435) 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 SERENU, INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
SERENU, INC. 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 27 words ▾

Uses: For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains. Provides cooling pain relief.

⏱️ Dosage and Administration 31 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.

⚠️ Warnings 93 words ▾

Warning: For external use only Do not use: On damaged or broken skin. When using this product: Keep out of eyes. Rinse with water to remove Do not bandage tightly.

Stop use and ask a doctor if: Rash or irritation develops and lasts. Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Keep out of reach of children.

If swallowed, get medical help, or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

🧪 Active Ingredient 9 words ▾

Active Ingredients Capsaicin 0.025% Menthol 8.00% Purpose Topical Analgesic

🧪 Inactive Ingredients 86 words ▾

Inactive Ingredients: Allantoin, Aloe Barbadnesis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), L-Arginine-Monohydrochloride, HCL, Amica Montana Flower Extract, Ascorbyl Phosphate (Liposomal Vitamin C), Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cannabis Saliva (Hemp) Seed Oil, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cyanocobalamin (Vitamin B12), Emu Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Ilex Paraquariensis (Verba Mate') Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Phospholipids, Sorbitan Olivate, Stearic Acid, Urea, Xanthan Gum, Zemea (Com) Propanediol, Zingiber Officinalis (Ginger) Extract.

🎯 Purpose 3 words ▾

Purpose Topical Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83670-0203-02 · Everlaan 83676-0436-00 · SERENU, →
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.