Capsaicin .25 mg/g Cream
by Rugby Laboratories · 1 TUBE in 1 CARTON (0536-2525-25) / 60 g in 1 TUBE
NDC 00536-2525-25
🏷️ FDA NDC (as labeled)
0536-2525-25
billing pads the labeler 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 →
🆔 Identity & classification
FDA NDC (as labeled)
0536-2525-25
Product NDC
0536-2525
11-digit billing NDC
00536252525
NCPDP billing unit
GM — per gram (weight)
RxCUI
198555
UNII
S07O44R1ZM
Application #
M017
SPL Set ID
c5915c84-84a2-46f6-9f97-0d9873e9944a
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2012-03-01
Route
TOPICAL
Dosage form
CREAM
Substance
CAPSAICIN
GPI-14
90850025003710
GPI class
Capsaicin
GCN Seq No
006017
GCN
33560
HICL code
002577
Ingredient (HICL)
Capsaicin
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
CAPSAICIN 0.025% CREAM
FDB brand name
Capsaicin
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0536-2525-25 — a 4-4-2 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 labeler segment → 00536-2525-25. 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
LabelerRugby Laboratories
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedMar 2012
Product typeHuman Otc Drug
Portfolio149 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
Label name CAPSAICIN 0.025% CREAM Ingredient Capsaicin
📖 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
- 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Capsaicin (prescription drug) — tap one for details:
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.
💬 Questions about Capsaicin?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
🧪 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 71DD5V995L
A synthetic polymer derived from acrylic acid, crosslinked to form a gel-like substance. It thickens formulations, improves texture, and helps distribute active ingredients evenly in topical products like creams and gels.
-
UNII 4Q43814HXS
Cetyl acetate is a waxy compound made by combining cetyl alcohol with acetic acid. It works as a binder and thickener in medicines, helping to hold ingredients together and give the product a smooth, creamy texture.
-
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 0057334FAB
A synthetic compound derived from glucose that combines water-repelling and water-attracting properties. It works as an emulsifier to help blend oil and water-based ingredients, and may also function as a thickener in creams and lotions.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
-
UNII 4OH5W9UM87
A synthetic emulsifier and surfactant derived from stearic acid. It helps oils and water mix together in liquid medicines and creams, and improves how the product spreads and feels on the skin.
-
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 2KR89I4H1Y
Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
-
UNII 9O3K93S3TK
Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
-
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.
11 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesacrylates/C10-30 alkyl acrylate crosspolymer, cetyl acetate, methylparaben, PPG-20 methyl glucose ether distearate, propylene glycol, propylparaben, stearate-100, stearic acid, stearyl alcohol, triethanolamine, water
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 system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.080 | $4.82 / 60 g |
| Medicaid paysCMS SDUD · 12 mo | $0.2431 | $14.59 / 60 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per g) — tap or hover for the price & month
▼ Down 9% over the last 24 months.
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Capsaicin .25 mg/gthis 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/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 | — |
| 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
🏛️
2012
On the market since
Mar 2012
📍
2026
Currently FDA-listed
14 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.
🗺️ Medicaid utilization & spend
📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00536-2525-25, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
25.6K
Units reimbursed last 4 qtrs
1.7M
Gross reimbursed last 4 qtrs
$418.1K
Avg / prescription
$16.36
Avg / unit
$0.2431
Latest quarter Q4 2025
5.3KRx
Medicaid pays / g
$0.2431
gross reimbursed
vs
NADAC / g
$0.0803
acquisition cost
=
Spread
+$0.1628
+203% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
Fee-for-service · 6,673 Rx Managed care · 18,884 Rx
State Medicaid map
Units reimbursed · per 100k residents
12.23,513
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00536-2525-25 You're viewing this | 1 TUBE in 1 CARTON (0536-2525-25) / 60 g in 1 TUBE | 2012-03-01 | Active |
📄 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses temporarily relieves minor aches and pains of muscles and joints due to: simple backache arthritis strains sprains
⏱️ Dosage and Administration ▾
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: ask a doctor
⚠️ Warnings ▾
Warnings For external use only Read all warnings and directions before use. Test first on small area of skin. Do not use on wounds or damaged skin if you are allergic to capsicum or chili peppers When using this product you may experience a burning sensation.
The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days. avoid contact with the eyes, lips, nose and mucous membranes do not tightly wrap or bandage the treated area do not apply heat to the treated area immediately before or after use Stop use and ask a doctor if condition worsens or does not improve after regular use severe burning persists or blistering occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
📦 Storage and Handling ▾
Other information store at room temperature 15° - 30°C (59° - 86°F)
🧪 Active Ingredient ▾
Active ingredient Capsaicin 0.025%
🧪 Inactive Ingredients ▾
Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, cetyl acetate, methylparaben, PPG-20 methyl glucose ether distearate, propylene glycol, propylparaben, stearate-100, stearic acid, stearyl alcohol, triethanolamine, water
🎯 Purpose ▾
Purpose External analgesic
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.