Owell Naturals Draw Salve, Arnica, Silicea Arnica Montana HPUS, Silicea HPUS .566 g/56.6g; .566 g/56.6g Salve, 56.6 g — NDC 83570-0468-02 package photo

Owell Naturals Draw Salve, Arnica, Silicea Arnica Montana HPUS, Silicea HPUS .566 g/56.6g; .566 g/56.6g Salve, 56.6 g

by Owell Naturals Brand LLC · 56.6 g in 1 JAR (83570-468-02)
NDC 83570-0468-02
🏷️ FDA NDC (as labeled) 83570-468-02 billing pads the product 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) 83570-468-02
Product NDC 83570-468
11-digit billing NDC 83570046802
UNII OZ0E5Y15PZ, ETJ7Z6XBU4
SPL Set ID 1c9dab31-de1f-911b-e063-6294a90a0391
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-05
Route TOPICAL
Dosage form SALVE
Substance ARNICA MONTANA FLOWER; SILICON DIOXIDE
Why two NDCs? The FDA registers this code as 83570-468-02 — 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 → 83570-0468-02. 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.

🏭 Manufacturer & labeler

LabelerOwell Naturals Brand LLC
Labeler code83570
First marketedJul 2024
Product typeHuman Otc Drug
Portfolio8 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

🧪 What is this product?

Owell Naturals Draw Salve is an unapproved homeopathic product applied to the skin as a salve. It contains arnica montana flower and silicea (silicon dioxide) as listed homeopathic ingredients. In homeopathic practice, arnica is traditionally used for minor skin irritation and bruising, while silicea is traditionally used to support the skin's natural drainage. Homeopathic products are based on traditional use and are not evaluated by the FDA for safety or effectiveness.

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 P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • UNII N20HL7Q941
    Camphor is a waxy, aromatic substance derived from camphor tree wood or made synthetically. In medicines, it typically serves as a preservative, flavoring agent, or mild skin irritant in topical products.
  • UNII D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • UNII DG4F8T839X
    A plant extract from comfrey leaves used as a natural ingredient in formulations. It may serve as a soothing agent or botanical additive in topical or oral preparations.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • UNII 67ZYA5T02K
    Frankincense oil is a natural aromatic extract from tree resin. In medicines, it's used as a fragrance and flavoring agent to improve taste and smell, and may also help preserve the product.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII LAV5U5022Y
    Methyl salicylate is a naturally derived liquid compound commonly found in wintergreen plants. In medicines, it's used as a flavoring agent and penetrating solvent to help distribute active ingredients evenly throughout topical products.
  • UNII 6UYK2W1W1E
    A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII HA5CX6676U
    White pine oil is a natural essential oil extracted from pine needles and wood. It's used in medicines as a flavoring agent and to provide a fresh, piney taste or aroma to the product.
  • UNII 7G1J5DA97F
    White wax is a refined, bleached plant-based or mineral wax that serves as a coating and hardening agent in medicines. It helps control how fast the drug dissolves and improves the product's texture and appearance.

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

The official label also statesInactive Ingredients Beeswax, Boswellia carterii (Frankincense) Oil, Calendula Officinalis (Marigold) Extract, Camphor USP, Eucalyptus Oil, Lavandula angustifolia (Lavender) Oil, Melaleuca alternifolia (Tea Tree) Oil, Methyl Salicylate, Olea Europaea (Olive) Fruit Oil, Pinus sylvestris (Pine) Leaf Oil, Ricinus communis (Castor) Seed Oil, Symphytum Officinale (Comfrey) 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 DailyMedingredient 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 eachPer 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Owell Naturals Draw Salve, Arnica, Silicea .566 g/56.6g; .566 g/56.6gthis 83570-0468-02 Owell 56.6 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

🏛️
2024
On the market since
Jul 2024
📍
2026
Currently FDA-listed
2 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
83570-0468-02 You're viewing this 56.6 g in 1 JAR (83570-468-02) 2024-07-05 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Owell Naturals Draw Salve, Arnica, Silicea Arnica Montana HPUS, Silicea HPUS .566 g/56.6g; .566 g/56.6g SALVE 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.
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 83570-468-02, 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: 83570-0468-02, written without dashes as 83570046802. 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 83570-0468-02, the first segment (83570) is the labeler code FDA assigned to Owell Naturals Brand LLC; the middle segment (0468) 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 Owell Naturals Brand LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Owell Naturals Brand 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 30 words

Uses temporarily relieves minor aches and pains associated with Boils Cysts Splinters Thorns Ingrown Hairs Pain Itch & Irritation Relief Dry Skin Insect Bites Bee Sting Cuts Poison Ivy/Oak Burns

⏱️ Dosage and Administration 27 words

Directions Use only as directed adults and children 12 years of age and older, apply to affected area children under 12 years of age, ask a doctor

⚠️ Warnings 66 words

Allergy Alert: If prone to allergic reaction from aspirin or salicylate, consult your doctor before using. Do Not Use: on wounds or damaged skin with a heating pad on a child under 12 years of age with arthritis-like conditions Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days

🧪 Active Ingredient 5 words

Arnica Montana, HPUS Silicea, HPUS

🧪 Inactive Ingredients 46 words

Inactive Ingredients Beeswax, Boswellia carterii (Frankincense) Oil, Calendula Officinalis (Marigold) Extract, Camphor USP, Eucalyptus Oil, Lavandula angustifolia (Lavender) Oil, Melaleuca alternifolia (Tea Tree) Oil, Methyl Salicylate, Olea Europaea (Olive) Fruit Oil, Pinus sylvestris (Pine) Leaf Oil, Ricinus communis (Castor) Seed Oil, Symphytum Officinale (Comfrey) Leaf Extract

🎯 Purpose 17 words

Arnica Montana HPUS 30C 1 percent Purpose Anti-inflammatory Silicea HPUS 30C 0.10 percent Purpose Minor skin eruptions

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.