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RoyceDerm Rosacea Treatment Cream. Sulphur 1X HPUS(10%) 11.4 g/114g Cream, 114 g — NDC 85424-0009-01 package photo

RoyceDerm Rosacea Treatment Cream. Sulphur 1X HPUS(10%) 11.4 g/114g Cream, 114 g

by RoyceDerm LLC · 114 g in 1 CARTON (85424-009-01)
NDC 85424-0009-01
🏷️ FDA NDC (as labeled) 85424-009-01 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 →

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) 85424-009-01
Product NDC 85424-009
11-digit billing NDC 85424000901
UNII 70FD1KFU70
UPC 0850068161560
Application # M006
SPL Set ID 3df717fc-cf2f-8a9a-e063-6394a90ae4e2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-30
Route TOPICAL
Dosage form CREAM
Substance SULFUR
Why two NDCs? The FDA registers this code as 85424-009-01 — 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 → 85424-0009-01. 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

LabelerRoyceDerm LLC
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code85424
First marketedSep 2025
Product typeHuman Otc Drug
Portfolio31 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?

RoyceDerm Rosacea Treatment Cream is a topical cream containing sulfur as its active ingredient. Sulfur is commonly used in over-the-counter skin products for conditions like rosacea, acne, and other inflammatory skin concerns. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for sulfur-based skin treatments rather than undergoing individual product review. The cream is applied directly to affected skin areas.

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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 5C5403N26O
    Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • UNII KIZ4X2EHYX
    A plant extract from the aloe vera leaf, used in medicines as a moisturizing agent and skin-conditioning ingredient. It helps soften and soothe the product's texture in topical formulations.
  • 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 F2VW3D43YT
    Azelaic acid is a naturally occurring compound that acts as a preservative and antimicrobial agent in medications. It helps prevent bacterial and fungal growth, extending the product's shelf life and stability.
  • UNII DRF395F9AY
    Betaine salicylate is a salt compound combining betaine, an amino acid derivative, with salicylic acid. It may function as a buffer or pH adjuster in formulations to maintain stability and consistency.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • 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 4YS74Q4G4J
    A plant extract from Centella asiatica containing natural compounds called triterpenoids. It's used as an active ingredient in some formulations for its purported skin-supporting properties, though it functions as a botanical additive rather than a structural component of the medicine.
  • 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 8FA93U5T67
    A waxy substance made from plant oils that acts as an emulsifier and thickener. It helps mix oil and water components in the medicine and gives the product a smooth texture.
  • 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 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 I670DAL4SZ
    A preservative that fights bacteria and fungi. It keeps medicines and topical products stable and safe from microbial contamination 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 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • UNII 2865993309
    Ethylhexyl palmitate is an oily chemical made from palm oil and alcohol. It acts as an emollient and skin-conditioning agent in topical medicines, helping the product spread smoothly and keeping skin soft.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • 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 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 YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII 1I96OHX6EK
    A cyclic carbohydrate derived from plant starch that acts as a solubilizer and stabilizer. It helps dissolve poorly water-soluble drugs and protects active ingredients from degradation in the formulation.
  • UNII 918X1OUF1E
    Isohexadecane is a synthetic hydrocarbon oil used as an emollient and solvent in topical medicines. It helps dissolve active ingredients and improves spreadability and absorption through the skin.
  • UNII CQD833204Z
    A natural lipid derived from soybean used to help dissolve, stabilize, and improve absorption of active ingredients in medicines. It acts as an emulsifier and solubilizing agent in liquid or injectable formulations.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • 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 788QAG3W8A
    A synthetic polymer that combines polyethylene glycol, glycidyl ether, and sodium hyaluronate. It acts as a thickener and film-former in topical products, helping maintain texture and improve how the medicine spreads on skin.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII Q7UI015FF9
    A synthetic polymer material used as a thickener and stabilizer in liquid formulations. It helps create the right texture and prevents separation of ingredients in medicines and topical products.
  • UNII 03KCY6P7UT
    A waxy compound derived from cetyl alcohol and phosphoric acid. It acts as an emulsifier to help blend oil and water ingredients, and as a thickener to give the medicine its proper texture and consistency.
  • 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 WN66R7GL93
    A modified form of hyaluronic acid, a naturally occurring substance that holds water. Used as a thickener, lubricant, and moisture-retaining agent in formulations, especially in topical or injectable products.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII 18YWT2KYS8
    This is a recombinant protein receptor used as an active pharmaceutical ingredient rather than a typical inactive excipient. It functions as a therapeutic agent by binding growth factors to modulate cellular responses in disease treatment.
  • 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.

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

The official label also statesAqua, Propylene Glycol, Cetearyl Alcohol,Niacinamide, lsohexadecane, Ethylhexyl Palmitate, Azelaic Acid, Caprylic/Capric Triglyceride, Hydroxypropyl Cyclodextrin, Dimethicone, Disodium Phosphate, Glyceryl Stearate, Panthenol, Polyacrylate Crosspolymer-6, Ceteareth-25, Potassium Cetyl Phosphate, Allantoin, Cetearyl Glucoside.PEG-100 Stearate, Phenoxyethanol, Methyl Cyclodextrin, 1,2-Hexanediol,Centella Asiatica Extract, Chlorphenesin, Xanthan Gum, Aloe Barbadensis Extract, Camellia Sinensis Leaf Extract, Glycerin, Acacia Senegal Gum,Maltodextrin, Butylene Glycol, Pentylene Glycol, Betaine Salicylate,Sodium Hyaluronate, Sodium Acetylated Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxyacetophenone, Hydrolyzed Sodium Hyaluronate, Phosphatidylcholine, Ethylhexylglycerin,Ceramide NP, Beta-Glucan, Sodium Stearoyl Glutamate

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
RoyceDerm Rosacea Treatment Cream. 11.4 g/114gthis 85424-0009-01 RoyceDerm 114 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

🏛️
2025
On the market since
Sep 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85424-0009-01 You're viewing this 114 g in 1 CARTON (85424-009-01) 2025-09-30 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
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 "Otc Monograph Drug". 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 85424-009-01, 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: 85424-0009-01, written without dashes as 85424000901. 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 85424-0009-01, the first segment (85424) is the labeler code FDA assigned to RoyceDerm LLC; the middle segment (0009) 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 RoyceDerm LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
RoyceDerm 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 19 words ▾

Cleanse and dry skin. Apply a thin layer toaffected areas. Use thrice daily or as directed by a doctor.

⏱️ Dosage and Administration 20 words ▾

Protects and helps relieve red, irritated, or sensitive skin Reduce visible dryness and discomfort Helps improve the lookuneven skin tone

⚠️ Warnings 75 words ▾

For external use only conduct a patch test on a small area of skin, such as in front of the ear or under the jawline. Avoid contact with eyes. lf contact occurs, rinse thoroughly with water. On damaged or wounded skin large areasof skin condition worsens or persists for more than 7 days ask a health professional before In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

🧪 Active Ingredient 3 words ▾

Sulphur 1X HPUS*(10%)

🧪 Inactive Ingredients 74 words ▾

Aqua, Propylene Glycol, Cetearyl Alcohol,Niacinamide, lsohexadecane, Ethylhexyl Palmitate, Azelaic Acid, Caprylic/Capric Triglyceride, Hydroxypropyl Cyclodextrin, Dimethicone, Disodium Phosphate, Glyceryl Stearate, Panthenol, Polyacrylate Crosspolymer-6, Ceteareth-25, Potassium Cetyl Phosphate, Allantoin, Cetearyl Glucoside.PEG-100 Stearate, Phenoxyethanol, Methyl Cyclodextrin, 1,2-Hexanediol,Centella Asiatica Extract, Chlorphenesin, Xanthan Gum, Aloe Barbadensis Extract, Camellia Sinensis Leaf Extract, Glycerin, Acacia Senegal Gum,Maltodextrin, Butylene Glycol, Pentylene Glycol, Betaine Salicylate,Sodium Hyaluronate, Sodium Acetylated Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxyacetophenone, Hydrolyzed Sodium Hyaluronate, Phosphatidylcholine, Ethylhexylglycerin,Ceramide NP, Beta-Glucan, Sodium Stearoyl Glutamate

🎯 Purpose 2 words ▾

Rosacea/acne treatment

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85424-0008-01 · RoyceDerm 85424-0010-01 · RoyceDerm →
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.