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Coca Lief Menthol, Methylsalicylate 1500 mg/100000mg; 12500 mg/100000mg Gel, 100000 mg — NDC 84831-0096-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Coca Lief Menthol, Methylsalicylate 1500 mg/100000mg; 12500 mg/100000mg Gel, 100000 mg — NDC 84831-096-01 (Billing 84831-0096-01)

by INDUSTRIA QUIMICO FARMACEUTICA SIGMA CORP. S.R.L. · 100000 mg in 1 TUBE

This is a package of 100,000 mg of Coca Lief Menthol, Methylsalicylate 1500 mg/100000mg; 12500 mg/100000mg Gel from INDUSTRIA QUIMICO FARMACEUTICA SIGMA CORP. S.R.L., no longer marketed (first marketed Jan 2025), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 84831-0096-01
🏷️ FDA NDC (as labeled) 84831-096-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 84831-096-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84831 labeler · 096 product · 01 package
Package marketed since
Jan 20, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8483109601 3
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84831-096-01
Product NDC 84831-096
11-digit billing NDC 84831009601
UNII LAV5U5022Y, L7T10EIP3A
SPL Set ID 2bedd2d0-b430-1844-e063-6294a90a965f
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2025-01-20
Route TOPICAL
Dosage form GEL
Substance METHYL SALICYLATE; MENTHOL
Why two NDCs? The FDA registers this code as 84831-096-01 — 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 → 84831-0096-01. 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.

Clinical

🧪 What is this product?

Coca Lief Menthol is a topical gel marketed as a homeopathic product containing menthol and methyl salicylate. In homeopathic practice, these ingredients are traditionally used for temporary relief of minor aches and discomfort. This product is not evaluated by the FDA for safety or effectiveness; homeopathic products are marketed based on homeopathic tradition rather than modern clinical evidence.

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.
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
84831-0096-01 You're viewing this Main listing 100000 mg in 1 TUBE 2025-01-20 — Inactivated by FDA

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Coca Lief 1500 mg/100000mg; 12500 mg/100000mgthis 84831-0096-01 INDUSTRIA 100000 mg — — Discontinued —
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
Jan 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.

What it looks like

Color green
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.

  • 21900 mg / 100000 mg UNII 7528N5H79B
    A liquid solvent derived from grain fermentation. In medicines, it dissolves active ingredients, helps preserve the product, and improves how the body absorbs the drug.
  • 1000 mg / 100000 mg UNII 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • 500 mg / 100000 mg UNII D052HE394V
    A plant extract from coca leaves used as a flavoring agent in some pharmaceutical formulations. It may contribute taste or aroma to the medicine.
  • 401 mg / 100000 mg 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.
  • 800 mg / 100000 mg UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • 100 mg / 100000 mg 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.
  • 300 mg / 100000 mg 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.
  • 60999 mg / 100000 mg 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 statesTrolamine, 95% Isopropyl Alcohol, cellulose, Gycerine, Coca-leaf extract.

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

LabelerINDUSTRIA QUIMICO FARMACEUTICA SIGMA CORP. S.R.L.
Labeler code84831
First marketedJan 2025
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.

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 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 4 words ▾

For External Use Only

⏱️ Dosage and Administration 8 words ▾

aPPLY 3 TO 4 TIMES DAILY AS NEEDED

⚠️ Warnings 36 words ▾

If you are pregnant, nursing, or have a medical condition consult a healthcare professional before use. For External Use Only If pregnant or breastfeeding consult a healthcare professional before use. Keep out of reach of children.

🧪 Active Ingredient 16 words ▾

Active Ingredients Menthol ........... 1.5 mg ..... Topical Analgesic Methyl Salicylate 12.5 mg ..... Topical Analgesic

🧪 Inactive Ingredients 10 words ▾

Inactive Ingredients Trolamine, 95% Isopropyl Alcohol, cellulose, Gycerine, Coca-leaf extract.

🎯 Purpose 17 words ▾

Purpose Temporary relief of aches and pains associated with <Arthritis, Carpal Tunnel, Swelling, Sprains, Brusing and Inflamation

📄 Ask a Doctor or Pharmacist Before Use If 16 words ▾

If you are pregnant, nursing, or have a medical condition consult a healthcare professional before use.

📄 Stop Use and Ask a Doctor If 36 words ▾

Stop use and consult a doctor if condition worsens or if sympotoms last for more than 7 days, or if condition clears up but occurs again a few days later, or if you dicsover a rash/irritation.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breastfeeding consult a healthcare professional before use.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 21 words ▾

Store at 66 to 92 degress Farenheit. Do not leave in direct sunlight. aPPLY 3 TO 4 TIMES DAILY AS NEEDED

📄 Package Label / Principal Display Panel 2 words ▾

DISPLAY PANEL

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 MENTHOL, METHYLSALICYLATE — the ingredient across all brands.

Top reported reactions

Nausea5
Oral Candidiasis5
Diarrhoea4
Vomiting4
Dysphagia3
Dyspnoea3
Headache3

Age at onset

Elderly1

Reporter sex

14 reports
Female · 100%

Serious outcomes

Hospitalization7
Disabling3
Death3
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 1 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 Homeopathic listing No longer marketed (per FDA listing data)

About homeopathic listings

COCA LIEF MENTHOL, METHYLSALICYLATE 1500 mg/100000mg; 12500 mg/100000mg GEL is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

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 "Unapproved Homeopathic". 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
INDUSTRIA QUIMICO FARMACEUTICA SIGMA CORP. S.R.L. 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.
← 84830-7210-02 · NewAlley 84834-0542-00 · VITA →
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.