Home › NDC Lookup › Ingredients › Capsaicin › 83158-0387-02
BRONSON SOOTHE Pain Relief CAPSAICIN .25 mg/mL Cream, 59 mL — NDC 83158-0387-02 package photo

BRONSON SOOTHE Pain Relief CAPSAICIN .25 mg/mL Cream, 59 mL

by BRONSON NUTRITIONALS, LLC · 59 mL in 1 TUBE (83158-387-02)
NDC 83158-0387-02
🏷️ FDA NDC (as labeled) 83158-387-02 billing pads the product segment with a zero
This package
Contains59 mL Pack sizes2 compare ↓
Also comes in: 118 ml 83158-0387-04
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) 83158-387-02
Product NDC 83158-387
11-digit billing NDC 83158038702
RxCUI 198555
UNII S07O44R1ZM
UPC 0716563614041, 0716563614010
Application # M017
SPL Set ID cedf8f43-b9a3-4a06-b3a1-cf82668541f8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-12-26
Route TOPICAL
Dosage form CREAM
Substance CAPSAICIN
Why two NDCs? The FDA registers this code as 83158-387-02 — 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 → 83158-0387-02. 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

LabelerBRONSON NUTRITIONALS, LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code83158
First marketedDec 2022
Product typeHuman Otc Drug
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 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?
📖 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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • 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 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 QN83US2B0N
    Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
  • UNII E4F12ROE70
    A refined mineral oil derived from crude petroleum containing 13 to 14 carbon chains. It acts as a solvent, emollient, and carrier in topical formulations to help dissolve active ingredients and improve product texture and spreadability.
  • 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 FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • UNII H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • 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 ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • 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 046Y1357I6
    Lamium album whole is a plant-derived ingredient used as a natural coloring, flavoring, or traditional botanical component in some formulations. It may help provide color, taste, or texture to the finished medicine.
  • UNII Z95S6G8201
    A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 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.
  • UNII 101I4J0U34
    Witch hazel is a plant extract obtained from the leaves and bark of the North American shrub Hamamelis virginiana. It functions as an astringent and skin-conditioning agent in topical products, helping to tone and prepare the skin.

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

The official label also statesAloe barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica montana Flower Extract, Ascorbyl Palmitate (Vitamin C), C13-14 Isoparaffin, Cetyl Alcohol, Chamomilla recutita (Chamomile) Extract, Diazolidinyl Urea, Emu Oil, Hamamelis virginiana (Witch Hazel) Distillate, Isopropyl Alcohol, Isopropyl Myristate, Lamium album (White Nettle) Extract, Laureth-7, Menthol, Methyl Paraben, Methylsulfonylmethane (MSM), Parfum (Fragrance), PEG-8, Polyacrylamide, Propyl Paraben, Propylene Glycol, Sorbitol, Tocopheryl Acetate (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.

💲 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: 118 ml
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/g 80684-0138-00 FOURSTAR 42.5 g — — FDA listed —
BRONSON SOOTHE Pain Relief .25 mg/mLthis 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

🏛️
2022
On the market since
Dec 2022
📍
2026
Currently FDA-listed
4 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
83158-0387-02 You're viewing this 59 mL in 1 TUBE (83158-387-02) 2022-12-26 Active
83158-0387-04 118 mL in 1 TUBE (83158-387-04) 2022-12-26 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 83158-0387-02?
NDC 83158-0387-02 contains 59 mL — 59 ml in 1 tube.
What is the difference between NDC 83158-0387-02 and NDC 83158-0387-04?
Both are BRONSON SOOTHE Pain Relief CAPSAICIN .25 mg/mL Cream — the drug itself is identical. NDC 83158-0387-02 is the 59 mL package, while NDC 83158-0387-04 is the 118 ml package.
What NDC number is used to bill for this package of BRONSON SOOTHE Pain Relief CAPSAICIN .25 mg/mL Cream?
Bill NDC 83158-0387-02 — the 11-digit billing format is 83158038702. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 83158-387-02, 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: 83158-0387-02, written without dashes as 83158038702. 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 83158-0387-02, the first segment (83158) is the labeler code FDA assigned to BRONSON NUTRITIONALS, LLC; the middle segment (0387) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 BRONSON NUTRITIONALS, 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 118 ml (83158-0387-04). 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?
BRONSON NUTRITIONALS, 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.

📄 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 23 words ▾

USES: For temporary relief of minor aches and pains of the muscles and joints associted with simple backache, arthritis, strains, bruises and sprains.

⏱️ Dosage and Administration 15 words ▾

DIRECTIONS: Apply directly to affected area. Do not use more than four times per day.

⚠️ Warnings 56 words ▾

WARNINGS For external use only. Avoid contact with eyes. Do not apply to open wounds or damaged skin. If symtoms persist for more than seven days, discontinue use and consult physician. Keep out of reach of children. If swallowed, contact physician. Do not bandage tightly . If pregnant or breast feeding, contact physician prior to use.

🧪 Active Ingredient 7 words ▾

ACTIVE INGREDIENT Capsaicin 0.025% PURPOSE External Analgesic

🧪 Inactive Ingredients 64 words ▾

INACTIVE INGREDIENTS: Aloe barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica montana Flower Extract, Ascorbyl Palmitate (Vitamin C), C13-14 Isoparaffin, Cetyl Alcohol, Chamomilla recutita (Chamomile) Extract, Diazolidinyl Urea, Emu Oil, Hamamelis virginiana (Witch Hazel) Distillate, Isopropyl Alcohol, Isopropyl Myristate, Lamium album (White Nettle) Extract, Laureth-7, Menthol, Methyl Paraben, Methylsulfonylmethane (MSM), Parfum (Fragrance), PEG-8, Polyacrylamide, Propyl Paraben, Propylene Glycol, Sorbitol, Tocopheryl Acetate (Vitamin E).

🎯 Purpose 3 words ▾

PURPOSE External Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 83157-3772-09 · Lotte 83162-0001-01 · Xenova →
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.