Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Leader Capsaicin Pain Relief Cream .1 g/100g Cream, 1 tube — NDC 70000-0549-1 (Billing 70000-0549-01)
by Cardinal Health 110 dba LEADER · 1 TUBE in 1 BOX / 42.5 g in 1 TUBE
This is a package of 1 tube of Leader Capsaicin Pain Relief Cream .1 g/100g Cream from Cardinal Health 110 dba LEADER, marketed since May 2020 and currently FDA-listed; retail pharmacies pay about $0.2068 per g (NADAC). It is this product's only package size.
NDC 70000-0549-01
🏷️ FDA NDC (as labeled)
70000-0549-1
billing pads the package segment with a zero
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 70000-0549-1 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 70000 labeler · 0549 product · 1 package
- Package marketed since
- May 11, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 7000005491 5
- Medicaid fills, this package
- 2,368 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
70000-0549-1
Product NDC
70000-0549
11-digit billing NDC
70000054901
NCPDP billing unit
GM — per gram (weight)
RxCUI
646333
UNII
S07O44R1ZM
Application #
M017
SPL Set ID
a5620709-0fed-4979-e053-2a95a90ac654
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2020-05-11
Route
TOPICAL
Dosage form
CREAM
Substance
CAPSAICIN
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
90850025003735
GPI class
Capsaicin Pain Relief
GCN Seq No
058057
GCN
23373
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 0.1% CREAM
FDB brand name
Capsaicin
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 058057
- GCN: 23373
- GPI-14 (Medi-Span): 90850025003735
- HICL (First Databank): 002577
- AHFS class code: 84:92.00.00
- RxCUI (RxNorm): 646333
Why two NDCs?
The FDA registers this code as 70000-0549-1 — a 5-4-1 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 package segment → 70000-0549-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Label name CAPSAICIN 0.1% CREAM Ingredient Capsaicin
📗 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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
💬 Questions about Capsaicin?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.207 | $8.79 / 42.5 g |
| Medicaid paysCMS SDUD · 12 mo | $0.3552 | $15.10 / 42.5 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
▲ Up 5% over the last 13 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.
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 70000-0549-01 You're viewing this Main listing | 1 TUBE in 1 BOX / 42.5 g in 1 TUBE | 2020-05-11 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rugby Capsaicin Cream .1 g/100g 00536-1264-56 | Rugby | 1 tube | $0.207 | — | Availability likely | — |
| Capsaicin .1 g/100g 50268-0198-42 | AvPAK | 1 tube | $0.207 | — | Availability likely | — |
| Leader Capsaicin Pain Relief Cream .1 g/100gthis 70000-0549-01 | Cardinal | 1 tube | $0.207 | — | Availability likely | — |
| Walgreens Arthritis Pain Relief Capsaicin Analgesic 1 mg/g 00363-0837-01 | Walgreen | 1 tube | — | — | FDA listed | — |
| Heat Pain Relief .1 g/100g 00363-6263-07 | Walgreen | 1 applicator | — | — | FDA listed | — |
| Earths Care Arthritis .1 g/100g 24286-1559-02 | DLC | 1 tube | — | — | FDA listed | — |
| Capzasin HP Arthritis Pain Relief .001 g/g 41167-7514-02 | Chattem, | 1 tube | — | — | FDA listed | — |
| Capsaicin .001 g/g 50268-0197-56 | AvPAK | 1 tube | — | — | FDA listed | — |
| Capsaicin 0.1 Percent .1 g/100g 50488-1060-06 | Alexso, | 60 g | — | — | FDA listed | — |
| Capsaicin 0.1% Cream 1 mg/g 59088-0242-08 | Puretek | 120 g | — | — | FDA listed | — |
| Cvs Capsaicin .1 g/100g 59779-0381-42 | CVS | 1 tube | — | — | FDA listed | — |
| Capsaicin HP Arthritis Pain Relief .1 g/100g 69375-0006-60 | Nationwide | 1 tube | — | — | FDA listed | — |
| Capsaicin Cream .1 g/100g 69396-0103-02 | Trifecta | 1 tube | — | — | FDA listed | — |
| Capzix .001 g/g 72847-0316-20 | Toprail | 1 tube | — | — | FDA listed | — |
| Capsaicin Cream .1 g/100g 73141-0558-02 | A2A | 1 tube | — | — | FDA listed | — |
| Capsaicin .1 g/100g 76420-0753-42 | Asclemed | 1 tube | — | — | FDA listed | — |
| Toast Screamin Hot .1 g/100g 78983-0102-05 | IDEAZ, | 148 g | — | — | FDA listed | — |
| Capsaicin Cream .1 g/100g 81533-0200-15 | Noble | 1 tube | — | — | FDA listed | — |
| NeroCare Capsaicin Neuropathy Relief Cream .1 g/100g 84066-0108-01 | Guangzhou | 100 g | — | — | FDA listed | — |
| Dr. Luke Capsaicin Cream Extra Strength .1 g/100g 87147-0003-01 | DANOUS | 114 g | — | — | Discontinued | — |
| Easment advanced absorption cream .12 g/120g 87352-0001-01 | Easment | 120 g | — | — | FDA listed | — |
| High Potency Pain Relief .1 g/100g 87773-0001-01 | Xiamen | 114 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
🏛️
2020
On the market since
May 2020
📍
2026
Currently FDA-listed
6 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.
- FDA Orange Book · refreshed Oct 3, 2026
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.
🧪 Avoiding an ingredient? See Capsaicin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerCardinal Health 110 dba LEADER
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedMay 2020
Product typeHuman Otc Drug
Portfolio11 products on file
More NDCs from Cardinal Health 110 dba LEADER labeler code 70000
- Leader General Protection SPF 30 Sunscreen avobenzone, homosalate, octisalate, octocrylene 30 mg/mL; 100 mg/mL; 50 mg/mL; 100 mg/mL Lotion NDC 70000-0536-1
- Gentle Laxative Bisacodyl 5 mg Tablet NDC 70000-0538-1
- Leader Athletes Foot Clotrimazole .01 g/g Cream NDC 70000-0542-1
- Leader Hydrocortisone with Aloe .01 g/g Cream NDC 70000-0543-1
- Leader Anti-Itch Camphor, Menthol .5 g/100g; .5 g/100g Lotion NDC 70000-0546-1
- Leader Bacitracin Zinc 500 [USP'U]/g Ointment NDC 70000-0547-1
- Leader Therapeutic Dandruff Anti-Dandruff, anti-seborrheic dematitis and anti-psoriasis Salicylic Acid 30 mg/mL Shampoo NDC 70000-0550-1
- Diclofenac sodium 10 mg/g Gel NDC 70000-0555-1
- Capsaicin Hot Patches .025 g/100g Patch NDC 70000-0556-1
- Leader PAIN RELIEF PATCHES LIDOCAINE 4 g/100g Patch NDC 70000-0557-1
- Cold and Heat Lidocaine Patch Plus Menthol 4 g/100g; 1 g/100g Patch NDC 70000-0558-1
- Nicotine Mini nicotine polacrilex 4 mg Lozenge NDC 70000-0559-1
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Stop Use and Ask a Doctor If
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses For the temporary relief of minor aches and pains of muscles and joints associated with: Arthritis Simple Backache Strains Sprains Bruises
⏱️ Dosage and Administration ▾
Directions Adults and Children over 18 years: Apply to affected area Massage into the painful area until thoroughly absorbed Repeat as necessary but not more than 3 to 4 times daily WASH HANDS WITH SOAP AND WATER AFTER APPLYING Children 18 years and younger: Ask a doctor
⚠️ Warnings ▾
Warnings For external use only: TEST FIRST ON SMALL AREA OF SKIN. When using this product: Use only as directed Do not apply to wounds, damaged, broken or irritated sin Do not use if you are allergic to capsicum or chili peppers Avoid contact with the eyes or mucous membranes A slight burning sensation may occur upon application, but generally disappears in several days If severe burning occurs, discontinue use Do not expose the treated area to heat or direct sunlight Do not bandage Do not use with heating pad Do not use at the same time as other topical analgesics
📦 Storage and Handling ▾
Other Information Store at room temperature 15°-30°F (59°-86°F)
🧪 Active Ingredient ▾
Active Ingredient Capsaicin 0.1%
🧪 Inactive Ingredients ▾
Inactive Ingredients Aloe barbadensis leaf juice, Ethylparaben, Glycerin, Clyceryl monostearate, Mineral Oil, Octadecyl alcohol, Petrolatum, Purified Water, Sodium lauryl Sulfate
🎯 Purpose ▾
Purpose Topical Analgesic
📄 Stop Use and Ask a Doctor If ▾
Stop Use and Ask Doctor Stop Use and Ask Doctor if: Condition worsens Symptoms persist for more than 7 days or clear up and occur again within a few days Redness is present irritation develops
🤰 If Pregnant or Breast-Feeding ▾
If Pregnant or Breast Feeding Ask a doctor before use
📄 Keep Out of Reach of Children ▾
Keep Out of the Reach of Children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
📄 Questions or Comments ▾
Questions 1 (800) 200- 6313 Distributed by Cardinal Health Dublin, Ohio 43017 This product is not manufactured or distrubuted by Chattem Inc. owner of registered trademark Capzasin HP, 2020 Cardinal Health Leader and Logos are trademarks of Cardinal Health. All other marks are the property of their respective owners www.myleader.com Made in China
📄 Package Label / Principal Display Panel ▾
LEADER CAPSAICIN CREAM
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 ↗
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 this package alone, 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 – Q1 2026 · 5 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
2.4K
Units reimbursed last 4 qtrs
109.3K
Gross reimbursed last 4 qtrs
$38.8K
Avg / prescription
$16.40
Avg / unit
$0.3552
Latest quarter Q1 2026
594Rx
Medicaid pays / g
$0.3552
gross reimbursed
vs
NADAC / g
$0.2068
acquisition cost
=
Spread
+$0.1484
+72% 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 · 1,696 Rx Managed care · 672 Rx
State Medicaid map
Units reimbursed · per 100k residents
27.0328
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.
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 — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 41%
Female · 59%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
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.