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Sheffield Arthritis and Muscle Pain Relief CAPSICUM OLEORESIN .25 mg/g Cream — NDC 11527-089-54 (Billing 11527-0089-54)

by Sheffield Pharmaceuticals LLC · 1 TUBE in 1 CARTON / 43 g in 1 TUBE

This is a package of Sheffield Arthritis and Muscle Pain Relief CAPSICUM OLEORESIN .25 mg/g Cream from Sheffield Pharmaceuticals LLC, marketed since Apr 2010 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 11527-0089-54
🏷️ FDA NDC (as labeled) 11527-089-54 billing pads the product segment with a zero
This package
Contains43 g in 1 tube Pack sizes2 compare ↓
Main listing for product 11527-089 · Also comes in: 60 g 11527-089-60
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) 11527-089-54
Product NDC 11527-089
11-digit billing NDC 11527008954
RxCUI 198555
UNII UW86K581WY
Application # M017
SPL Set ID 80a1bc65-2986-491f-a062-307d28b08ccb
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-04-14
Route TOPICAL
Dosage form CREAM
Substance CAPSICUM OLEORESIN
Quick answers
  • RxCUI (RxNorm): 198555
Why two NDCs? The FDA registers this code as 11527-089-54 — 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 → 11527-0089-54. 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

📖 What it is MedlinePlus · NLM

Topical capsaicin is used to relieve minor pain in muscles and joints caused by arthritis, backaches, muscle strains, bruises, cramps, and sprains. Capsaicin is a substance that is found in chili peppers. It works by affecting nerve cells in the skin that are associated with pain, which results in decreased activity of these nerve cells and a reduced sense of pain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It gives temporary relief of minor aches and pains in muscles and joints. That includes pain from simple backache, arthritis, strains, bruises and sprains.
  • Clean and dry the area, then put the patch on intact skin right after taking it out of the pouch. Adults can use up to 3 patches a day, one at a time, and each should come off with...
  • You may notice a burning feeling, and warm water, sweat or heat can make it stronger. Avoid use within an hour before or after a shower, bath, sauna or hard exercise. Never use it...
  • Keep it off your face, eyes, other mucous membranes, and any wounds or irritated, broken, sunburned or chapped skin. If it gets in your eyes, rinse continually with cool water and...
📖 Read our full Capsaicin Topical 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.

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.
Try another pack size: 60 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
11527-0089-54 You're viewing this Main listing 1 TUBE in 1 CARTON / 43 g in 1 TUBE 2010-04-14 — Active
11527-0089-60 11527-089-60 1 TUBE in 1 CARTON / 60 g in 1 TUBE 2020-12-22 — Discontinued by firm

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 43 g in 1 tube.
What NDC number is used to bill for this package of Sheffield Arthritis and Muscle Pain Relief CAPSICUM OLEORESIN .25 mg/g Cream?
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
Capsaicin .25 mg/g 00536-2525-25 Rugby 1 tube $0.082 — Availability likely —
Capsaicin External Analgesic .25 mg/g 50268-0195-60 AvPAK 1 tube $0.082 — Availability likely —
Sheffield Arthritis and Muscle Pain Relief .25 mg/gthis 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/g 80684-0138-00 FOURSTAR 42.5 g — — FDA listed —
BRONSON SOOTHE Pain Relief .25 mg/mL 83158-0387-02 BRONSON 59 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

🏛️
2010
On the market since
Apr 2010
📍
2026
Currently FDA-listed
16 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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 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 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII I9O0E3H2ZE
    Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • 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 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.

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

The official label also statesBenzyl Alcohol, Cetyl Alcohol, Glyceryl Sterate, Isopropyl Myristate, Paraffin, PEG-100 Stearate, Petrolatum, Purified Water, Sorbitol

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

LabelerSheffield Pharmaceuticals LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code11527
First marketedApr 2010
Product typeHuman Otc Drug
Portfolio29 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

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

⏱️ Dosage and Administration 18 words ▾

Other Information Store at controlled room temperature 20°- 25°C (68° - 77°F) Close the cap tightly after use

⚠️ Warnings 173 words ▾

Warnings For external use only Avoid contact with the eyes and mucous membranes If condition 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. Do not apply to wounds or damaged skin. Do not bandage tightly.

Do not use with a heating pad or on wounds, damaged, broken (open) or irritated skin. Discontinue use if excessive irritation of skin develops. If pregnant or breast feeding, ask a health professional before use.

A temporary burning sensation may occur upon application, but generally disappears in a few days Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately Directions Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Unless treating hands, wash thoroughly with soap and water immediately after use.

🧪 Active Ingredient 5 words ▾

Active Ingredient Capsicum Oleoresin 0.025%

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients Benzyl Alcohol, Cetyl Alcohol, Glyceryl Sterate, Isopropyl Myristate, Paraffin, PEG-100 Stearate, Petrolatum, Purified Water , Sorbitol

🎯 Purpose 3 words ▾

Purpose <Topical analgesic>

📄 Keep Out of Reach of Children 23 words ▾

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

📄 Package Label / Principal Display Panel 67 words ▾

Principal Display Panel – 60 g Carton Label Sheffield NDC 11527-089-60 Made in the USA ARTHRITIS & MUSCLE PAIN RELIEF CREAM Topical Analgesic NET WT. 60g (2.11oz) Principal Display Panel – 60g Carton Label

Principal Display Panel – 60g Tube Label Sheffield NDC 11527-089-60 Made in the USA ARTHRITIS & MUSCLE PAIN RELIEF CREAM Topical Analgesic NET WT. 60g (2.11oz) Principal Display Panel – 60g Tube Label

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 Sheffield Arthritis and Muscle Pain Relief (this brand).

Top reported reactions

Immune Thrombocytopenia9
Weight Increased9
Withdrawal Syndrome5
Dizziness4
Treatment Failure4
Fatigue3
Acute Kidney Injury2

Age at onset

Adult2

Reporter sex

23 reports
Male · 14%
Female · 86%

Serious outcomes

Hospitalization3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6 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.

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 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 Sheffield Pharmaceuticals 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 1 other package presentation of this same product, including 1 tube (11527-0089-60). 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?
Sheffield Pharmaceuticals 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.
← 11527-0080-60 · Sheffield 11527-0140-55 · Sheffield →
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.