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Thera Plus Pain Relief Arthritis and Muscle CAPSAICIN .25 mg/g Cream, 42.5 g

by FOURSTAR GROUP USA, INC. · 42.5 g in 1 TUBE (80684-138-00)
NDC 80684-0138-00
🏷️ FDA NDC (as labeled) 80684-138-00 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) 80684-138-00
Product NDC 80684-138
11-digit billing NDC 80684013800
RxCUI 198555
UNII S07O44R1ZM
UPC 0049696700436
Application # M017
SPL Set ID dcff0a2d-7190-4b0c-abde-ba009b8ef005
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-28
Route TOPICAL
Dosage form CREAM
Substance CAPSAICIN
Why two NDCs? The FDA registers this code as 80684-138-00 — 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 → 80684-0138-00. 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.

🏷️ 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.

🏭 Manufacturer & labeler

LabelerFOURSTAR GROUP USA, INC.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code80684
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio147 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

📗 Our plain-language guide HelloPharmacist
  • Yes, completely normal — and it actually means the medicine is working. Capsaicin activates the same pain-sensing receptors in your skin that respond to heat and spicy food. That b...
  • Why does capsaicin burn when I put it on? Is that normal?
  • For most OTC creams and ointments, you can apply up to 3 to 4 times a day. For OTC patches, apply to clean, dry skin and remove after no more than 8 hours — again, up to 3 to 4 tim...
  • How often should I apply capsaicin cream or use the patch?
📖 Read our full Capsaicin guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Capsaicin (prescription drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Capsaicin (prescription drug) (3 interactions) — ranked by severity →
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 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 14255EXE39
    Ethylparaben is a preservative, a chemical that stops bacteria and mold from growing in the medicine. It keeps the product safe and effective throughout its shelf life.
  • 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • 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 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.

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

The official label also statescetostearyl alcohol,ethylparaben,glycerin,glyceryl monostearate,mineral oil,peregal O,petrolatum,purified water,stearic 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 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
Capsaicin .25 mg/g 00536-2525-25 Rugby 1 tube $0.080 — Availability likely —
Capsaicin External Analgesic .25 mg/g 50268-0195-60 AvPAK 1 tube $0.080 — Availability likely —
Sheffield Arthritis and Muscle Pain Relief .25 mg/g 11527-0089-54 Sheffield 1 tube — — FDA listed —
Capsaicin .025 g/100g 50488-1025-01 Alexso, 1 tube — — FDA listed —
CareALL Arthritis and Muscle .025 g/g 51824-0094-15 New 42.5 g — — FDA listed —
Capsaicin 0.025% Cream .025 mg/g 59088-0220-08 Puretek 120 g — — FDA listed —
DermacinRx Penetral Cream .25 mg/mL 59088-0310-08 PureTek 118 ml — — FDA listed —
Penetrex(r) Arthritis Pain Relief .025 g/100g 62742-4216-02 Allure 1 tube — — FDA listed —
Rugby Capsaicin External Analgesic .25 mg/g 63187-0660-60 Proficient 1 tube — — FDA listed —
Capsaicin External Analgesic .25 mg/g 68071-3430-02 NuCare 1 tube — — FDA listed —
Capsaicin .025 g/100g 69420-6025-01 SA3, 120 g — — FDA listed —
Melt Pain Away .025 g/100g 72683-0003-01 Proximity 200 g — — FDA listed —
Drs Pharmacy PAIN RELIEF MUSCLE ARITHRITIS .025 g/100g 80489-0099-01 OL 1 tube — — FDA listed —
Thera Plus Pain Relief Arthritis and Muscle .25 mg/gthis 80684-0138-00 FOURSTAR 42.5 g — — FDA listed —
BRONSON SOOTHE Pain Relief .25 mg/mL 83158-0387-02 BRONSON 59 ml — — FDA listed —
BIOSAVIA External Analgesic Pain Relief .25 mg/g 84680-0529-00 BIOSAVIA 117.5 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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80684-0138-00 You're viewing this 42.5 g in 1 TUBE (80684-138-00) 2025-02-28 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 — Not published for this NDC No photo available yet for this listing.
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 80684-138-00, 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: 80684-0138-00, written without dashes as 80684013800. 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 80684-0138-00, the first segment (80684) is the labeler code FDA assigned to FOURSTAR GROUP USA, INC.; the middle segment (0138) 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 FOURSTAR GROUP USA, INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
FOURSTAR GROUP USA, 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 22 words ▾

Uses for the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis atrains sprains bruises

⏱️ Dosage and Administration 55 words ▾

Directions Adults and children 18 years of age and older:apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application For best results,apply 3 to 4 times daily Children under 18 years of age: ask a doctor

⚠️ Warnings 107 words ▾

Warnings For external use only. Do not use on wounds or damaged skin with a heating pad on a child under 18 years of age with an arthritis-like condition When using this product avoid contact with eyes and mucous membranes do not bandage tightly Ask a doctor before use if you have pregnant breast feeding Stop use and ask a doctor if excessive skin irritation occurs condition worsens or symptoms persist for more than 7 days symptoms clear up and then 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 (1-800-222-1222).

🧪 Active Ingredient 7 words ▾

Active ingredients Capsaicin 0.025% Purpose Topical analgesic

🧪 Inactive Ingredients 9 words ▾

Inactive ingredients cetostearyl alcohol,ethylparaben,glycerin,glyceryl monostearate,mineral oil,peregal O,petrolatum,purified water,stearic acid

🎯 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 ↗
← 80684-0137-00 · Fourstar 80684-0139-00 · FOURSTAR →
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.