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Calm Eczema Therapy Cream Sulphur 12X 12 [hp_X]/mL Cream — NDC 50718-0011-01 package photo

Calm Eczema Therapy Cream Sulphur 12X 12 [hp_X]/mL Cream

by Kamedis · 1 TUBE in 1 CARTON (50718-0011-1) / 150 mL in 1 TUBE
NDC 50718-0011-01
🏷️ FDA NDC (as labeled) 50718-0011-1 billing pads the package 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 50718-0011-1
Product NDC 50718-0011
11-digit billing NDC 50718001101
UNII 70FD1KFU70
SPL Set ID 304d3afc-dc81-4e8b-821c-47c5402ddf45
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-01-01
Route TOPICAL
Dosage form CREAM
Substance SULFUR
Why two NDCs? The FDA registers this code as 50718-0011-1 — 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 → 50718-0011-01. 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.

🏭 Manufacturer & labeler

LabelerKamedis
Labeler code50718
First marketedJan 2018
Product typeHuman Otc Drug
Portfolio6 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?

Calm Eczema Therapy Cream is a topical cream marketed as a homeopathic product containing sulfur in a 12X potency dilution. In homeopathic practice, sulfur is traditionally used for skin conditions. This is an unapproved homeopathic product; homeopathic remedies are marketed based on homeopathic tradition and have not been evaluated by the FDA for safety or effectiveness.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII EU1ETP025C
    A waxy, oily substance derived from plant or animal sources. It acts as a lubricant and glidant to help the medicine powder flow smoothly during manufacturing and tablet formation.
  • UNII SNN716810P
    A waxy substance derived from lanolin, an oil from sheep's wool, that has been chemically modified. It acts as an emulsifier and thickener to help blend water and oil-based ingredients together and improve texture.
  • UNII 5YM66ALY0U
    A plant extract from the bark of ailanthus altissima, commonly known as tree of heaven. It may function as a natural flavoring agent, colorant, or botanical additive in formulations.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 5THT33P7X7
    A waxy, lipid-like substance derived from animal or plant sources. It helps soften and moisturize the skin by acting as an emollient and skin-conditioning agent in topical medicines and creams.
  • UNII F1X8L2B00J
    A naturally derived fatty substance that helps bind and condition the product's texture. It works as an emollient and skin-conditioning agent in topical formulations, helping maintain moisture and smoothness.
  • UNII 4370DF050B
    Ceramide NP is a waxy, lipid-based substance that mimics natural skin oils. It's used in topical formulations as an emollient and skin-conditioning agent to help soften, smooth, and protect the skin barrier.
  • UNII 9M64UO4C25
    A synthetic oily substance used as an emollient and texture enhancer in medicines. It helps soften formulations, improves how the medicine spreads or feels on skin, and can act as a lubricant in tablets or capsules.
  • UNII 09FUA47KNA
    Cetearyl glucoside is a plant-derived surfactant made from vegetable oils and glucose. It helps oils and water mix together in creams and lotions, and can also soften and smooth the skin feel of the product.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 4Q43814HXS
    Cetyl acetate is a waxy compound made by combining cetyl alcohol with acetic acid. It works as a binder and thickener in medicines, helping to hold ingredients together and give the product a smooth, creamy texture.
  • 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 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • UNII V1IA3S3CUS
    A plant extract derived from Cnidium monnieri fruit, commonly used in traditional Asian medicine preparations. In formulations, it may serve as an active botanical ingredient or flavoring agent, though its specific role depends on the product type.
  • UNII 2KAG279R6R
    Dehydroacetic acid is a synthetic preservative that prevents mold, yeast, and bacterial growth in medicines. It extends shelf life by protecting the product from spoilage during storage and use.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • 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 FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII S270N0TRQY
    Hyaluronic acid is a naturally occurring substance found in skin and joints. In medicines, it acts as a moisturizer and thickening agent to improve texture and help the product spread smoothly.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII R17X820ROL
    Magnesium aspartate is magnesium combined with the amino acid aspartate. It is used as a mineral supplement ingredient and may help with tablet binding and nutrient delivery in formulations.
  • 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 T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII GIN46U9Q2Q
    Phytosphingosine is a naturally derived fatty compound that helps stabilize and thicken skincare and cosmetic formulations. It works as an emollient and conditioning agent to improve texture and skin feel in topical products.
  • UNII OC4598NZEQ
    Potassium aspartate is a salt compound that provides potassium and aspartic acid. It serves as a mineral supplement ingredient and electrolyte source in medications and formulations.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII G025DAL7CE
    A plant extract from rhubarb root used as a natural colorant and flavoring agent in medicines. It may also help stimulate bowel movement in laxative formulations.
  • UNII 4NYV2HT01X
    A plant extract from the roots of Sanguisorba officinalis (burnett). Used in formulations as a natural thickener, preservative, or conditioning agent to improve texture and stability.
  • UNII Z711V88R5F
    Sarcosine is a small amino acid naturally found in foods and the body. In medicines, it acts as a buffer and pH regulator to keep the formulation stable and prevent unwanted chemical changes.
  • UNII 7J95K7ID2S
    A plant extract from the roots of Chinese skullcap, used as a natural coloring agent and to add mild flavor to medicines. It may also help preserve the product's stability.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • UNII JW3VT57I11
    A plant-based cleaning agent derived from coconut oil and wheat proteins. It acts as a surfactant and emulsifier to help mix ingredients and improve texture in the formulation.
  • UNII 7243K85WFO
    Sodium lauroyl lactylate is a mild surfactant derived from natural fats and lactic acid. It acts as an emulsifier and solubilizer to help blend oil and water-based ingredients and improve how the body absorbs the active drug.
  • UNII A8005KSX95
    Stearyl acetate is a waxy compound made by combining stearic acid with acetic acid. In medicines, it acts as a binder and lubricant to help hold ingredients together and allow tablets to move smoothly through manufacturing equipment.
  • UNII 274KW0O50M
    Sucrose stearate is a compound made from sugar and stearic acid (a fatty substance). It works as an emulsifier and surfactant to help mix oils and water-based ingredients together in the medicine.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesacetylated lanolin alcohol, Baikal skullcap (Scutellaria baicalensis) root extract, benzyl alcohol, caprylic/capric triglyceride, carbomer, ceramide AP, ceramide EOP, ceramide NP, cetearyl alcohol, cetearyl ethylhexanoate, cetearyl glucoside, cetyl acetate, cetyl alcohol, Chinese rhubarb (Rheum palmatum) root extract, cholesterol, dehydroacetic acid, dimethicone, glycerin, glyceryl stearate, great burnet (Sanguisorba officinalis) root extract, hyaluronic acid, lactic acid, licorice (Glycyrrhiza glabra) root extract, magnesium aspartate, mineral oil, Monnier's snowparsley (Cnidium monnieri) fruit extract, oleyl acetate, PEG-100 stearate, petrolatum, phytosphingosine, potassium aspartate, potassium sorbate, propylene glycol, sarcosine, shea butter (Butyrospermum parkii), sodium cocoyl amino acids, sodium lauroyl lactylate, stearyl acetate, sucrose stearate, tree of heaven (Ailanthus altissima) bark extract, vitamin E (tocopheryl acetate), water, xanthan gum

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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Calm Eczema Therapy Cream 12 [hp_X]/mLthis 50718-0011-01 Kamedis 1 tube — — 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

🏛️
2018
On the market since
Jan 2018
📍
2026
Currently FDA-listed
8 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
50718-0011-01 You're viewing this 1 TUBE in 1 CARTON (50718-0011-1) / 150 mL in 1 TUBE 2018-01-01 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

Calm Eczema Therapy Cream Sulphur 12X 12 [hp_X]/mL 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 50718-0011-1, 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: 50718-0011-01, written without dashes as 50718001101. 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 50718-0011-01, the first segment (50718) is the labeler code FDA assigned to Kamedis; the middle segment (0011) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Kamedis. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Kamedis 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 16 words ▾

Uses • temporarily protects and helps relieve minor skin irritation and itching due to: rashes eczema

⏱️ Dosage and Administration 33 words ▾

Directions adults and children 6 months of age and older • apply twice daily or as needed • massage cream into skin until fully absorbed for babies under 6 months, consult a doctor

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 27 words ▾

Active ingredient Sulphur 12X HPUS* * The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

🧪 Inactive Ingredients 126 words ▾

Inactive ingredients acetylated lanolin alcohol, Baikal skullcap ( Scutellaria baicalensis ) root extract, benzyl alcohol, caprylic/capric triglyceride, carbomer, ceramide AP, ceramide EOP, ceramide NP, cetearyl alcohol, cetearyl ethylhexanoate, cetearyl glucoside, cetyl acetate, cetyl alcohol, Chinese rhubarb ( Rheum palmatum ) root extract, cholesterol, dehydroacetic acid, dimethicone, glycerin, glyceryl stearate, great burnet ( Sanguisorba officinalis ) root extract, hyaluronic acid, lactic acid, licorice ( Glycyrrhiza glabra ) root extract, magnesium aspartate, mineral oil, Monnier's snowparsley ( Cnidium monnieri ) fruit extract, oleyl acetate, PEG-100 stearate, petrolatum, phytosphingosine, potassium aspartate, potassium sorbate, propylene glycol, sarcosine, shea butter ( Butyrospermum parkii ), sodium cocoyl amino acids, sodium lauroyl lactylate, stearyl acetate, sucrose stearate, tree of heaven ( Ailanthus altissima ) bark extract, vitamin E (tocopheryl acetate), water, xanthan gum

🎯 Purpose 3 words ▾

Purpose Skin Treatment

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50711-0014-01 · Strem 50718-0012-01 · Kamedis →
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.