Home › NDC Lookup › Ingredients › Salicylic Acid 2% › 85424-0028-01
RoyceDerm Seborrheic Scalp .spray. Salicylic Acid 2% 2.4 g/120g Spray, 120 g — NDC 85424-0028-01 package photo

RoyceDerm Seborrheic Scalp .spray. Salicylic Acid 2% 2.4 g/120g Spray, 120 g

by RoyceDerm LLC · 120 g in 1 CARTON (85424-028-01)
NDC 85424-0028-01
🏷️ FDA NDC (as labeled) 85424-028-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 6, 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) 85424-028-01
Product NDC 85424-028
11-digit billing NDC 85424002801
RxCUI 1048903
UNII O414PZ4LPZ
Application # M032
SPL Set ID 55246263-7345-ba65-e063-6294a90ab163
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-07-17
Route TOPICAL
Dosage form SPRAY
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 85424-028-01 — 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 → 85424-0028-01. 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 marketedJul 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

📖 About the active ingredient: Salicylic Acid MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or b...

Read the full MedlinePlus article ↗
🧪 What is this product?

RoyceDerm Seborrheic Scalp is a topical spray containing salicylic acid 2%, marketed as an over-the-counter monograph drug. Salicylic acid is commonly used in scalp care products to help soften and loosen buildup on the skin. This spray format delivers the ingredient directly to the scalp area for typical use in seborrheic conditions affecting the head.

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 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 RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII 3UVP41R77R
    Avena sativa kernel oil is a natural oil extracted from oat seeds. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII 6SO6U10H04
    Biotin is a B-vitamin used as a nutritional supplement in some medications. It may also serve as a colorant or marker in formulations.
  • 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 3G6A5W338E
    Caffeine is a natural stimulant compound commonly extracted from coffee beans and tea leaves. In medicines, it serves as an active booster in pain relievers and cold products to enhance alertness and improve the effectiveness of other ingredients.
  • UNII C4TH45M3K8
    A plant-derived liquid extracted from centella asiatica leaves, used as a solvent and humectant to dissolve other ingredients and help retain moisture in topical formulations.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 00IF91KFKQ
    A natural extract from saffron crocus flowers. Used in medicines as a coloring agent to give products a golden-yellow hue and sometimes to add subtle flavor or aroma to the formulation.
  • UNII 7E6SK9QDT8
    Cyclodextrins are ring-shaped sugar molecules derived from starch. They're used in medicines as solubilizers to help poorly dissolving drugs dissolve better, and sometimes as binders or stabilizers.
  • UNII 95K9FHM51V
    A synthetic antimicrobial preservative used in small amounts to prevent bacterial and fungal growth in liquid medicines and topical products, helping extend shelf life.
  • UNII CA2Y0FE3FX
    A salt derived from licorice root extract, used as a flavoring agent and sweetener. It may also help soothe and protect mucous membranes in throat lozenges and cough products.
  • UNII 6559FC0U1B
    A plant extract from the gentiana macrophylla root used in traditional medicine formulations. It typically serves as a flavoring agent or botanical ingredient to add taste and traditional properties to the medicine.
  • UNII 06T1X86LXT
    A plant-derived ingredient from Gentiana scabra (Asian gentian), used as a natural flavoring and bitter agent to enhance taste or mask unpleasant flavors in medicines.
  • 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 8FP93ED6H2
    Witch hazel is a plant extract made from the leaves and twigs of the witch hazel shrub. In medicines, it works as a soothing and astringent ingredient that helps reduce inflammation and tighten skin.
  • 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 KJM5A6A3YL
    A chemical compound that acts as a preservative and antimicrobial agent in medicines. It helps prevent bacterial and fungal growth, extending the product's shelf life and maintaining stability.
  • UNII ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • 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 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 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • UNII 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 8ZQ0AYU1TT
    Pullulan is a natural polysaccharide, a type of carbohydrate made from yeast. It acts as a binder and film-former to hold tablet ingredients together and create protective coatings on capsules.
  • UNII 8LGU7VM393
    Rosemary leaf oil is a natural aromatic oil extracted from rosemary plants. It's used in medicines as a flavoring agent and preservative to help protect the product from spoilage.
  • UNII W00MO9Z07L
    A plant extract from Swertia bimaculata used as a natural flavoring or bitter agent in medicines. It may help mask taste or contribute to the formulation's overall flavor profile.
  • UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its 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.

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

The official label also statesWater, Propanediol, Tromethamine,Butylene Glycol, PEG-40 Hydrogenated Castor Oil, Dipotassium Glycyrrhizate, Panthenol, Aloe Barbadensis Extract, Decyloxazolidi-none, Melaleuca Alternifolia (TeaTree) Leaf Oil, Laurylpyridinium Chloride, Glycerin, 1,2-Hexanediol,Crocus Sativus Flower Extract,Swertia Bimaculata Extract, Avena Sativa (Oat) Kernel Extract, Pullulan,Hydroxyacetophenone, Gentiana Scabra Extract, Gentiana Macrophyl-la Extract, Allantoin, Lavandula Angustifolia (Lavender) Oil, Citric Acid, Cyclodextrin, Niacinamide,Caffeine, Centella Asiatica Extract,Biotin, Hamamelis Virginiana (WitchHazel) Extract, Rosmarinus Officinalis (Rosemary) 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 mLPer 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 Seborrheic Scalp .spray. 2.4 g/120gthis 85424-0028-01 RoyceDerm 120 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
Jul 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85424-0028-01 You're viewing this 120 g in 1 CARTON (85424-028-01) 2026-07-17 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 85424-028-01, 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: 85424-0028-01, written without dashes as 85424002801. 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 85424-0028-01, the first segment (85424) is the labeler code FDA assigned to RoyceDerm LLC; the middle segment (0028) 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 36 words ▾

Adults and children 12 years & older: apply to affected areas one to four times daily or as directed by a doctor. spray directly onto the affected scalp area. massage gently if needed. do not rinse.

⏱️ Dosage and Administration 21 words ▾

controls the symptom of seborrheic dermatitis. helps prevent recurrence of skin and scalp itching,irritation, redness, flaking, scaling associated with seborrheic dermatitis

⚠️ Warnings 64 words ▾

For external use only. if you have a condition that covers a large area of the body. avoid contact with the eye. If contact occurs, rinse the eyes thoroughly with water. Stop and ask a doctor if condition worsens or does not improve after regular use of this product as directed. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 3 words ▾

Salicylic Acid 2.0%

🧪 Inactive Ingredients 61 words ▾

Water, Propanediol, Tromethamine,Butylene Glycol, PEG-40 Hydrogenated Castor Oil, Dipotassium Glycyrrhizate, Panthenol, Aloe Barbadensis Extract, Decyloxazolidi-none, Melaleuca Alternifolia (TeaTree) Leaf Oil, Laurylpyridinium Chloride, Glycerin, 1,2-Hexanediol,Crocus Sativus Flower Extract,Swertia Bimaculata Extract, Avena Sativa (Oat) Kernel Extract, Pullulan,Hydroxyacetophenone, Gentiana Scabra Extract, Gentiana Macrophyl-la Extract, Allantoin, Lavandula Angustifolia (Lavender) Oil, Citric Acid, Cyclodextrin, Niacinamide,Caffeine, Centella Asiatica Extract,Biotin, Hamamelis Virginiana (WitchHazel) Extract, Rosmarinus Officinalis (Rosemary) Extract.

🎯 Purpose 3 words ▾

Anti-Seborrheic Dermatitis, Antidandruff

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85424-0027-01 · RoyceDerm 85424-0029-01 · 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.