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RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment cream Salicylic Acid 3% 3 g/100g Cream, 100 g

by RoyceDerm LLC · 100 g in 1 CARTON (85424-014-01)
NDC 85424-0014-01
🏷️ FDA NDC (as labeled) 85424-014-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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) 85424-014-01
Product NDC 85424-014
11-digit billing NDC 85424001401
RxCUI 416910
UNII O414PZ4LPZ
Application # M032
SPL Set ID 496e178b-e29b-071e-e063-6394a90aa018
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-02-18
Route TOPICAL
Dosage form CREAM
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 85424-014-01 — 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 → 85424-0014-01. 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.

🏷️ RxNorm drug class

This medicine belongs to the Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerRoyceDerm LLC
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code85424
First marketedFeb 2026
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

📗 Our plain-language guide HelloPharmacist
  • It's designed to treat acne. Salicylic acid helps by loosening and removing dead skin cells that clog pores — the buildup that leads to breakouts. The multi-step system on this lab...
  • What is this salicylic acid product actually supposed to do for my skin?
  • Some mild tingling, stinging, and peeling is actually expected — that's the salicylic acid doing its job by clearing away dead skin cells. But if the burning or peeling feels exces...
  • My skin feels like it's burning and peeling. Is that normal?
📖 Read our full Salicylic Acid Topical guide →

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 72Q967Y48V
    Artemisia vulgaris oil is a plant-derived essential oil from mugwort. It functions as a flavoring agent and fragrance component in medicines, providing taste or aroma to the formulation.
  • UNII 04W97Z676Y
    A plant-derived natural substance from Bassia scoparia fruit used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping in the tablet or capsule.
  • UNII JK0MS9P8YL
    Cnidium monnieri fruit oil is a plant-derived oil extracted from the fruit of Cnidium monnieri (Chinese motherwort). In medicines, it serves as a fragrance component, skin conditioning agent, or delivery vehicle to improve product stability and absorption.
  • UNII LA97176ILS
    A plant-derived ingredient from the root bark of Dictamnus dasycarpus. It may function as a natural extract or traditional ingredient to support formulation stability or consistency in herbal preparations.
  • UNII PBG27B754G
    Phellodendron amurense bark is a plant-derived ingredient from the cork tree. It functions as a natural preservative and antimicrobial agent to help maintain product stability and prevent microbial growth.
  • UNII H51N91QNEB
    A plant extract from the smilax glabra vine used in traditional medicine preparations. It may function as a natural flavoring agent, botanical extract, or ingredient to support the product's intended formulation characteristics.
  • UNII IYR6K8KQ5K
    A plant extract from sophora flavescens root used as a natural colorant and flavoring agent in medicines. It may also help preserve the product and provide texture.
  • 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.

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

The official label also statesWater (Aqua), Artemisia Vulgaris Extract, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit Extract, Kochia ScopariaFruit Extract, Dictamnus Dasycarpus Root Bark Extract, Smilax Glabra Root Extract, Phellodendron Amurense Bark 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 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
TriDerma Psoriasis Control Face and Body Cream 3 g/100g 10738-0062-20 Genuine 1 tube — — FDA listed —
Gold Bond Psoriasis Relief Medicated Multi-Symptom 3 g/100g 41167-0413-02 Chattem, 113 g — — FDA listed —
Nizoral Psoriasis Relief 3 g/100g 55505-0224-33 Kramer 1 jar — — FDA listed —
Gold Bond Psoriasis Relief Medicated Multi-Symptom 3 g/100g 84714-0413-02 Gold 113 g — — FDA listed —
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment cream 3 g/100gthis 85424-0014-01 RoyceDerm 100 g — — FDA listed —
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment cream 3 g/100g 85424-0017-01 RoyceDerm 100 g — — FDA listed —
RoyceDerm Psoriasis Scalp .Shampoo. 3 g/100g 85424-0030-01 RoyceDerm 250 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

🏛️
2026
On the market since
Feb 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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 RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment cream (this brand).

Top reported reactions

Erythema1
Middle Insomnia1
Skin Discolouration1
Thermal Burn1

Reporter sex

1 reports
Male · 100%
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 NDCDescription Marketing startStatus
85424-0014-01 You're viewing this 100 g in 1 CARTON (85424-014-01) 2026-02-18 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 — 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 "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 85424-014-01, 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: 85424-0014-01, written without dashes as 85424001401. 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 85424-0014-01, the first segment (85424) is the labeler code FDA assigned to RoyceDerm LLC; the middle segment (0014) 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 21 words ▾

Adults and children 12 years and older: Apply to affected areasone to four times daily or as directed by a doctor.

⏱️ Dosage and Administration 26 words ▾

Controls the symptom of seborrheic dermatitis & psoriasis Helps prevent recurrence of skin & scalp itching, irritation, redness, flaking, scaling, associated with psoriasis & seborrheic dematitis

⚠️ Warnings 65 words ▾

For external use only. Ask a doctor before use you havea condition that covers a large area of the body. When usingthis product avoid contact with eyes. If contact occurs, rinse theeyes thoroughly with water. Stop and ask a doctor if conditionworsens or does not improve after regular use of this productas directed. If swallowed, getmedical help or contact a Poison Control Center right away.

🧪 Active Ingredient 3 words ▾

Salicylic Acid 3%

🧪 Inactive Ingredients 29 words ▾

Water (Aqua), Artemisia Vulgaris Extract, Sophora Flavescens Root Extract, Cnidium Monnieri Fruit Extract, Kochia ScopariaFruit Extract, Dictamnus Dasycarpus Root Bark Extract, Smilax Glabra Root Extract, Phellodendron Amurense Bark Extract

🎯 Purpose 3 words ▾

Anti-Seborrheic Dermatitis, Anti-Psoriasis

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85424-0013-01 · RoyceDerm 85424-0015-01 · 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.