NDC 61500-5547-00 — Topricin aesculus hippocastanum, arnica

🆔 Identity & classification

FDA NDC (as labeled) 61500-5547-0

Product NDC 61500-5547

11-digit billing NDC 61500554700

UNII 27YLU75U4W, O80TY208ZW, YHA2XLJ956, VB06AV5US8, 4QQN74LH4O, O9M1UQ4YIO +8 more

UPC 0609863010081

SPL Set ID 321e83de-71e8-20b4-e054-00144ff8d46c

DEA schedule Non-controlled

Marketing category UNAPPROVED HOMEOPATHIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2016-04-01

Route TOPICAL

Dosage form CREAM

Substance PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON

Why two NDCs? The FDA registers this code as 61500-5547-0 — 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 → 61500-5547-00. 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

LabelerTopical BioMedics, Inc.

Labeler code61500

First marketedApr 2016

Product typeHuman Otc Drug

Portfolio2 products on file

🔎 All NDCs from Topical BioMedics, Inc.

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?

Topricin is a topical cream containing multiple ingredients used in homeopathic practice, including plant extracts (arnica, calendula, echinacea, and ruta), minerals (graphite and phosphorus), and venom preparations (from snakes and a lizard species). In homeopathic tradition, these ingredients are prepared in highly diluted form and are typically applied to skin for various localized concerns. This is an unapproved homeopathic product marketed based on homeopathic principles rather than evaluated by the FDA for effectiveness.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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 UPY805K99W
A synthetic compound derived from caprylic acid that works as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
UNII C9H2L21V7U
A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
UNII 59TL3WG5CO
A synthetic polymer made by crosslinking acrylic acid with allyl sucrose. It thickens liquids, forms gels, and helps control how fast the medicine is released in your body.
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 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.
UNII TM2TZD4G4A
A plant-derived oily substance used as an emulsifier and solubilizer in medicines. It helps blend water and oil-based ingredients together and improves how the body absorbs certain active drugs.
UNII 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
UNII FM8D1RE2VP
A plant-based oil that has been chemically hardened to stay solid at room temperature. It works as a binder and lubricant to hold tablet ingredients together and help them release properly during digestion.
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 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 L0Q8IK9E08
A synthetic compound made from stearic acid and polyethylene glycol. It acts as an emulsifier and solubilizer, helping mix oil and water-based ingredients and keeping them blended throughout the medicine's shelf life.
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.

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

The official label also statesCaptex 300 (from coconut fatty acids), Carbopol® Ultrez 10 (from sucrose), Cetyl Alcohol (from coconut oil), Glycerine (vegetable-based), Hydrokote (palm kernel oil with lecithin), Isopropyl Myristate emollient (from palm seeds), Lipomulse (from coconut fatty acids), Purified Water, Sodium hydroxide, Spectrastat G 2 (derived from coconut), Steareth-21 (from stearic acid cocoa butter)

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 system	Per g	Per 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: 21 g 57 g 113 g 227 g 454 g

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Topricin 9 [hp_X]/227g; 6 [hp_X]/227g; 8 [hp_X]/227g; 4 [hp_X]/227g; 6 [hp_X]/227g; 8 [hp_X]/227g; 8 [hp_X]/227gthis 61500-5547-00	Topical	2 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

Apr 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.

🔬 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 Topricin (this brand).

Top reported reactions

Fatigue5

Asthenia4

Balance Disorder4

Disorientation4

Dyspnoea4

Insomnia4

Abdominal Pain3

Reporter sex

Male · 20%

Female · 80%

Serious outcomes

Disabling5

Hospitalization3

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
61500-5547-00 You're viewing this	2 g in 1 PACKET (61500-5547-0)	2016-06-01	Active
61500-5547-01	21 g in 1 TUBE (61500-5547-1)	2016-05-18	Active
61500-5547-02	57 g in 1 TUBE (61500-5547-2)	2016-05-18	Active
61500-5547-04	113 g in 1 JAR (61500-5547-4)	2016-05-18	Active
61500-5547-08	454 g in 1 BOTTLE (61500-5547-8)	2016-05-18	Active
61500-5547-09	227 g in 1 BOTTLE (61500-5547-9)	2016-05-18	Active

You're viewing the smallest of 6 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 61500-5547-00?

NDC 61500-5547-00 contains 2 g — 2 g in 1 packet.

What is the difference between NDC 61500-5547-00 and NDC 61500-5547-01?

Both are Topricin aesculus hippocastanum, arnica montana, belladonna, calendula officinalis, crotalus horridus, echinacea, graphites, heloderma horridum, lachesis mutus, naja tripudians, phosphorus, rhus toxicodendron, ruta graveolens, sulfur 9 [hp_X]/227g; 6 [hp_X]/227g; 8 [hp_X]/227g; 4 [hp_X]/227g; 6 [hp_X]/227g; 8 [hp_X]/227g; 8 [hp_X]/227g Cream — the drug itself is identical. NDC 61500-5547-00 is the 2 g package, while NDC 61500-5547-01 is the 21 g package.

What NDC number is used to bill for this package of Topricin aesculus hippocastanum, arnica montana, belladonna, calendula officinalis, crotalus horridus, echinacea, graphites, heloderma horridum, lachesis mutus, naja tripudians, phosphorus, rhus toxicodendron, ruta graveolens, sulfur 9 [hp_X]/227g; 6 [hp_X]/227g; 8 [hp_X]/227g; 4 [hp_X]/227g; 6 [hp_X]/227g; 8 [hp_X]/227g; 8 [hp_X]/227g Cream?

Bill NDC 61500-5547-00 — the 11-digit billing format is 61500554700. 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 Homeopathic listing

About homeopathic listings

Topricin aesculus hippocastanum, arnica montana, belladonna, calendula officinalis, crotalus horridus, echinacea, graphites, heloderma horridum, lachesis mutus, naja tripudians, phosphorus, rhus toxicodendron, ruta graveolens, sulfur 9 [hp_X]/227g; 6 [hp_X]/227g; 8 [hp_X]/227g; 4 [hp_X]/227g; 6 [hp_X]/227g; 8 [hp_X]/227g; 8 [hp_X]/227g CREAM 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 61500-5547-0, 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: 61500-5547-00, written without dashes as 61500554700. 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 61500-5547-00, the first segment (61500) is the labeler code FDA assigned to Topical BioMedics, Inc.; the middle segment (5547) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 Topical BioMedics, Inc.. 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 5 other package presentations of this same product, including 21 g (61500-5547-01), 57 g (61500-5547-02), 113 g (61500-5547-04). 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?

Topical BioMedics, 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.

📄 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 213 words ▾

Uses Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with: Joint pain in the toes, feet and ankles Heel pain/soreness (heel spurs) Bunions pain/soreness (big toe) Nerve pain (burning pain in feet) Gout (pain in big toe) Relieves arch pain, soft tissue pain, and ball of the foot Relieves nerve pain between toes Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis Tired aching feet, Tarsal Tunnel Syndrome Purpose Relieves pain of the Achilles tendon, swelling of the feet after walking Aids in treating injuries & bruising to muscles and joints Aids in treating night leg cramps, restless leg and muscle spasms Aids in rapid healing & treating dry skin on feet Relief of impact injuries & sudden pain in feet & ankles Relieves skin conditions Relief of swelling & burning pain o the feet & toes Relieves sudden sharp pain in the feet & ankle Relieves nerve injury pain Relief of coldness and cramping of the feet Relief of pain for sprains and joint pain of the feet, heel and post-surgical pain Relief of pain, soreness and bruising of the feet, ankle and shin Relieves itching, cracking of the skin and joint pain in toes and feet

⏱️ Dosage and Administration 50 words ▾

Directions Generously apply 3-4 times daily or more often if needed, 3 inches on and around affected area. Massage in until absorbed, re-apply before bedtime and in the morning. Use before and after sports work outs and competitions. Apply immediately for acute trauma injuries (sprain, strain, bruise, and impact injuries).

⚠️ Warnings 104 words ▾

Warnings For external use only. Do not apply in eyes. Ask doctor or pharmacist before using if you are taking prescription medication.

Ask a doctor before using if you are pregnant or nursing. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Use only as directed. See doctor if pain persists for more than 3 days or worsens, new symptoms occur, redness or swelling are present because these could be signs of a more serious condition. Before considering any self help regimen always consult your doctor, especially if you are taking a prescription medication.

🧪 Active Ingredient 39 words ▾

Active Ingredients Aesculus hippocastanum 6X Arnica montana 6X Belladona 6X Calendula officinalis 4X Crotalus horridus 8X Echinacea 4X Graphites 6X Heloderma horridum 8X Lachesis mutus 8X Naja tripudians 8X Phosphorus 9X Rhus toxicodendron 8X Ruta graveolens 6X Sulfur 8X

🧪 Inactive Ingredients 53 words ▾

Inactive Ingredients Captex 300 (from coconut fatty acids), Carbopol® Ultrez 10 (from sucrose), Cetyl Alcohol (from coconut oil), Glycerine (vegetable-based), Hydrokote (palm kernel oil with lecithin), Isopropyl Myristate emollient (from palm seeds), Lipomulse (from coconut fatty acids), Purified Water, Sodium hydroxide, Spectrastat G 2 (derived from coconut), Steareth-21 (from stearic acid cocoa butter)

🎯 Purpose 130 words ▾

Purpose Relieves pain of the Achilles tendon, swelling of the feet after walking Aids in treating injuries & bruising to muscles and joints Aids in treating night leg cramps, restless leg and muscle spasms Aids in rapid healing & treating dry skin on feet Relief of impact injuries & sudden pain in feet & ankles Relieves skin conditions Relief of swelling & burning pain o the feet & toes Relieves sudden sharp pain in the feet & ankle Relieves nerve injury pain Relief of coldness and cramping of the feet Relief of pain for sprains and joint pain of the feet, heel and post-surgical pain Relief of pain, soreness and bruising of the feet, ankle and shin Relieves itching, cracking of the skin and joint pain in toes and feet

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

🔗 Related NDC lookups

🧪 All Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur NDCsSame ingredient 🏭 All Topical labeler NDCsLabeler code 61500