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Traulevium Pain Relief Gel Arnica Montana, Calendula Officinalis, Hamamelis Virginiana, Echinacea, Echinacea Purpurea, Chamomilla, Symphytum Officinale, Bellis Perennis, Hypericum Perforatum, Millefolium, Aconitum Napellus, Belladonna, Mercurius Solubilis, Hepar Sulphuris Calcareum 3 [hp_X]/100g; .45 g/100g; .45 g/100g; .15 g/100g; .15 g/100g; .15 g/100g; 6 [hp_X]/100g Gel, 454 g — NDC 70857-004-16 (Billing 70857-0004-16)

by Medical Technology Products, Inc. · 454 g in 1 BOTTLE, PUMP

This is a package of 454 g of Traulevium Pain Relief Gel Arnica Montana, Calendula Officinalis, Hamamelis Virginiana, Echinacea, Echinacea Purpurea, Chamomilla, Symphytum Officinale, Bellis Perennis, Hypericum Perforatum, Millefolium, Aconitum Napellus, Belladonna, Mercurius Solubilis, Hepar Sulphuris Calcareum 3 [hp_X]/100g; .45 g/100g; .45 g/100g; .15 g/100g; .15 g/100g; .15 g/100g; 6 [hp_X]/100g Gel from Medical Technology Products, Inc., marketed since Sep 2016 and currently FDA-listed. It is this product's only package size.

NDC 70857-0004-16
🏷️ FDA NDC (as labeled) 70857-004-16 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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) 70857-004-16
Product NDC 70857-004
11-digit billing NDC 70857000416
UNII O80TY208ZW, 18E7415PXQ, T7S323PKJS, 4N9P6CC1DX, QI7G114Y98, G0R4UBI2ZZ +8 more
UPC 0742574246551
SPL Set ID 692daf7a-11e2-4f08-bdcf-1b9ac866d213
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-09-19
Route TOPICAL
Dosage form GEL
Substance ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ECHINACEA, UNSPECIFIED; ECHINACEA PURPUREA; MATRICARIA RECUTITA; COMFREY ROOT; BELLIS PERENNIS; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; A
Why two NDCs? The FDA registers this code as 70857-004-16 — 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 → 70857-0004-16. 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?

Traulevium Pain Relief Gel is a topical homeopathic product containing a blend of plant-derived and mineral ingredients traditionally used in homeopathic practice for minor pain and inflammation. The formula includes arnica, calendula, hamamelis, comfrey, and echinacea, along with other botanical and mineral substances in homeopathic dilutions. Homeopathic products are marketed based on traditional homeopathic principles and have not been evaluated by the FDA for effectiveness or safety.

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
70857-0004-16 You're viewing this Main listing 454 g in 1 BOTTLE, PUMP 2016-09-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Traulevium Pain Relief Gel 3 [hp_X]/100g; .45 g/100g; .45 g/100g; .15 g/100g; .15 g/100g; .15 g/100g; 6 [hp_X]/100gthis 70857-0004-16 Medical 454 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

🏛️
2016
On the market since
Sep 2016
📍
2026
Currently FDA-listed
10 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • 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.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

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

The official label also statesInactive ingredients: Carbopol 980, ethanol, purified water and sodium hydroxide.

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

LabelerMedical Technology Products, Inc.
Labeler code70857
First marketedSep 2016
Product typeHuman Otc Drug
Portfolio4 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

USES Uses** For the temporary relief of: Joint Pain Back Pain Muscular Pain

⏱️ Dosage and Administration 45 words ▾

DIRECTIONS Adults and children 4 years and older Apply generously to affected areas 2 to 3 times daily, or more often if necessary. Massage thoroughly into the skin. If appropriate, mild compression or occlusive bandaging may be applied. Children under 4 Consult your healthcare provider.

⚠️ Warnings 95 words ▾

WARNINGS Warnings For external use only. Do not apply over open wounds or broken skin. If symptoms worsen or persist for more than a week, or if a rash develops, a healthcare provider should be consulted.

In rare cases, allergic skin reactions may develop. Do not use if known sensitivity to Traulevium or any of its ingredients exists. Keep out of reach of children .

If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, consult a healthcare provider before use. Keep out of the reach of children.

🧪 Active Ingredient 139 words ▾

ACTIVE INGREDIENTS Active ingredients (HPUS*) Purpose** Each 100 g of gel contains: Arnica Montana, Radix 3X 1500 mg Reduces joint & back pain Calendula Officinalis MT (N) 450 mg Relieves pain Hamamelis Virginiana MT (N) 450 mg Relieves joint & muscle soreness Echinacea MT (N) 150 mg Relieves pain Echinacea Purpurea MT (N) 150 mg Relieves pain Chamomilla MT (N) 150 mg Soothing pain relief Symphytum Officinale 4X (Final concentration 6X) 100 mg Relieves joint pain Bellis Perennis MT (M) 100 mg Relieves joint & muscle soreness Hypericum Perforatum 6X 90 mg Relieves pain Millefolium MT (N) 90 mg Relieves pain Aconitum Napellus 1X (Final concentration 4X) 50 mg Reduces joint & back pain Belladonna 1X 50 mg Reduces back pain Mercurius Solubilis 6X 40 mg Reduces joint & back pain Hepar Sulphuris Calcareum 6X 25 mg Relieves pain

🧪 Inactive Ingredients 12 words ▾

INACTIVE INGREDIENTS Inactive ingredients: Carbopol 980, ethanol, purified water and sodium hydroxide.

🎯 Purpose 3 words ▾

Pain Relief Gel

📄 Keep Out of Reach of Children 7 words ▾

Keep out of the reach of children.

📄 Other Information 67 words ▾

OTHER INFORMATION Other information Tamper evident : Do not use if protective seal around the pump is broken or missing. Store at room temperature. Protect from light. **These statements have not been reviewed by the Food and Drug Administration. They are supported by traditional homeopathic principles. *The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

📄 Questions or Comments 32 words ▾

QUESTIONS? Questions? Call 1.866.440.7703 or e-mail [email protected] Made in the USA. Manufactured exclusively for Medical Technology Products, Inc. by OHM pharma Inc. Medical Technology Products, Inc. Riviera Beach, FL 33407, USA. www.traulevium.com

📄 Package Label / Principal Display Panel 42 words ▾

NDC 70857-004-16 Traulevium ™ Pain Relief Gel Homeopathic Medicine Compare to Traumeel®. Traumeel is a brand name owned by Biologische Heilmittel Heel GmbH. Traulevium is not associated with the brand owner. Net Wt. 16oz (454 g) 16oz bottle label Pain Relief Gel

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Traulevium Pain Relief Gel Arnica Montana, Calendula Officinalis, Hamamelis Virginiana, Echinacea, Echinacea Purpurea, Chamomilla, Symphytum Officinale, Bellis Perennis, Hypericum Perforatum, Millefolium, Aconitum Napellus, Belladonna, Mercurius Solubilis, Hepar Sulphuris Calcareum 3 [hp_X]/100g; .45 g/100g; .45 g/100g; .15 g/100g; .15 g/100g; .15 g/100g; 6 [hp_X]/100g 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 — 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 "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.
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 Medical Technology Products, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Medical Technology Products, Inc. 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.
← 70857-0003-02 · Medical 70859-0100-01 · NuCare →
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.