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Kenkoderm Psoriasis Moisturizing Salicylic Acid 2 g/100g Cream, 295 g

by Nexgel,Inc. · 295 g in 1 JAR (85286-004-01)
NDC 85286-0004-01
🏷️ FDA NDC (as labeled) 85286-004-01 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) 85286-004-01
Product NDC 85286-004
11-digit billing NDC 85286000401
RxCUI 317152
UNII O414PZ4LPZ
UPC 0860004351221
Application # M032
SPL Set ID 31ce20a2-95ae-e424-e063-6394a90af18a
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-02
Route TOPICAL
Dosage form CREAM
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 85286-004-01 — 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 → 85286-0004-01. 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

LabelerNexgel,Inc.
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code85286
First marketedApr 2025
Product typeHuman Otc Drug
Portfolio2 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 5SHP745C61
    A quaternary ammonium compound used as an antistatic agent and conditioning ingredient in solid dosage forms. It reduces static electricity buildup during manufacturing and helps improve the texture and flow of powders and granules in tablets or capsules.
  • 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 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 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 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 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 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • 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 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 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 412ZHA4T4Y
    A plant-derived oil extracted from meadowfoam seeds. It acts as an emollient and skin-conditioning agent, helping soften and smooth the product texture while improving how it spreads on skin.
  • 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 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 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 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 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 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 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 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 R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.
  • 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.

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

The official label also statesWater (Aqua), Urea, Propylene Glycol, Glyceryl Stearate SE, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Limnanthes Alba (Meadowfoam) Seed Oil, Glycerin, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Behentrimonium Methosulfate, Sodium Hyaluronate, Niacinamide, Ceramide NP, Ceramide AP, Ceramide EOP, Tocopherol, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Dimethicone, Carbomer, Xanthan Gum, Phenoxyethanol, Disodium EDTA, Ethylhexylglycerin, Sodium Hydroxide

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
Anew Bare Acne Clearing Treatment 2% Salicylic Acid 20 mg/mL 10096-2932-01 THE 1 tube — — FDA listed —
Proactiv Plus Retexturizing Toner 20 mg/mL 11410-0051-00 Alchemee, 1 bottle — — FDA listed —
Nas Max Strength Spot Treatment 2 g/100g 26052-0022-01 BURT'S 1 tube — — FDA listed —
CeraVe Developed with Dermatologists Psoriasis Moisturizing 20 mg/g 49967-0701-01 L'Oreal 227 g — — FDA listed —
Asepxia Acne Treatment 20 mg/g 50066-0064-01 Genomma 1 tube — — FDA listed —
Clear Exfoliating Solution Paulas Choice 2 g/100mL 56152-5002-01 Cosmetic 118 ml — — FDA listed —
Spot Acne Treatment Oil Free 0.75oz 2 g/100g 57337-0168-01 Rejoice 21 g — — FDA listed —
Spot Acne Treatment Oil Free 0.75oz 2 g/100g 58503-0204-01 China 21 g — — FDA listed —
Atrix Acne Treatment 20 mg/mL 59088-0446-05 PureTek 59 ml — — FDA listed —
Acne Spot Treatment 2% Bha 2 g/100mL 61328-0404-05 Skinfix, 15 ml — — FDA listed —
DermaClear Serum 20 mg/mL 62742-4069-02 Allure 1 tube — — FDA listed —
Dermaclear Mask 20 mg/g 62742-4074-02 Allure 1 tube — — FDA listed —
Advanced DermaClear Serum 2 g/100g 62742-4280-02 Allure 1 bottle — — FDA listed —
Natureplex Psoriasis 20 mg/g 67234-0073-01 Natureplex, 1 tube — — FDA listed —
Alumier MD Acne Balancing Serum 20 mg/mL 69473-0002-01 Alumier 1 bottle — — FDA listed —
DermaD ATOPIC DERMATITIS Therapeutic 20 mg/g 70794-0101-28 Chen 81 g — — FDA listed —
DermaD JOCK ITCH Therapeutic 20 mg/g 70794-0201-82 Chen 81 g — — FDA listed —
DermaD Psoriasis Therapeutic 20 mg/g 70794-0261-25 Chen 81 g — — FDA listed —
DermaD ANTI-ITCH Therapeutic 20 mg/g 70794-0313-94 Chen 81 g — — FDA listed —
DermaD ANTIFUNGAL Therapeutic 20 mg/g 70794-0708-85 Chen 81 g — — FDA listed —
MILANI ERASE BASE BLEMISH CONTROL PRIMER Salicylic Acid 20 mg/mL 71435-0005-00 New 30 ml — — FDA listed —
Tiege Hanley 20 mg/mL 71714-0003-24 Tiege 24 ml — — FDA listed —
MDacne Customized Acne Treatment Salicylic Acid 20 mg/mL 71804-0533-00 MDAlgorithms 1 tube — — FDA listed —
Soraresal 2 g/100g 73526-0002-02 Summer 1 bottle — — FDA listed —
Kenkoderm Psoriasis Moisturizing 2 g/100g 73632-0004-01 Olympus 295 g — — FDA listed —
ELF Blemish Control Face Primer Clear 2 g/100mL 76354-0210-10 e.l.f. 30 ml — — FDA listed —
ELF Clear Blemish Control Face Primer 2 g/100mL 76354-0624-01 e.l.f. 14 ml — — FDA listed —
Therapeutic Hydrogel 1 g/50g 78863-1090-01 Noon 1 bottle — — FDA listed —
Equate 20 mg/mL 79903-0317-68 Walmart 200 ml — — FDA listed —
VANIBISS BUTT and THIGHS Acne Treatment Cream 20 mg/mL 81890-0192-00 Vanibiss 1 jar — — FDA listed —
SIMPLY VITAL Acne Face Cream 20 mg/mL 82460-0272-00 ALPHA 60 ml — — FDA listed —
Acne Toner Serum 2 g/100mL 82870-0003-01 Dime 60 ml — — FDA listed —
Acne Spot Treatment 2 g/100mL 82870-0006-01 Dime 15 ml — — FDA listed —
Pureskin Seborrheic Dermatitis Psoriasis Cream 2 g/100mL 83887-0007-01 Changsha 100 ml — — Discontinued —
Tula Skincare Breakout Star Lightweight Acne Moisturizer 2 g/100mL 84126-0229-15 The 15 ml — — FDA listed —
Acne Treatment Cream 2 g/100mL 84356-0006-01 Guangzhou 50 ml — — FDA listed —
Perricone MD Acne Relief Maximum Strength Clearing Treatment 2 g/100mL 84448-0301-59 THG 1 bottle — — FDA listed —
Kenkoderm Psoriasis Moisturizing 2 g/100gthis 85286-0004-01 Nexgel,Inc. 295 g — — FDA listed —
Salicylic Acid 2 g/100g 71819-0003-04 D3 113 g — — FDA listed —
Asepxia Charcoal Acne Bar 2 g/100g 50066-0801-01 Genomma 1 applicator — — FDA listed —
Asepxia Neutral Acne Bar 2 g/100g 50066-0802-01 Genomma 1 applicator — — FDA listed —
Asepxia Oil-Free Acne Bar 2 g/100g 50066-0803-01 Genomma 1 applicator — — FDA listed —
Asepxia Scrub Acne Bar 2 g/100g 50066-0804-01 Genomma 1 applicator — — FDA listed —
Asepxia Softening Acne Bar 2 g/100g 50066-0805-01 Genomma 1 applicator — — FDA listed —
Tingl Exfoliating Pads 2 g/100g 83286-0011-01 Drmtlgy, 60 patches — — FDA listed —
Perricone MD Acne Relief Maximum Strength Spot Gel 2 g/100g 84448-0538-14 THG 1 tube — — FDA listed —
Alba Natural Acnedote Astringent 2 g/100g 61995-2753-06 The 177 g — — FDA listed —
PCA SKIN Intensive Clarity Treatment 2 g/100g 68726-0359-02 CP 1 tube — — FDA listed —
Clear Proof Clarifying Cleansing Gel Acne Medication 2 g/100g 51531-1349-01 Mary 28 g — — FDA listed —
Blemish Control Bar 2 g/100g 68726-0439-01 CP 1 jar — — FDA listed —
AL00761 Alba Botanica Acnedote Face and Body Scrub 2 g/100g 61995-3761-09 The 227 g — — FDA listed —
Acne Warrior Body Scrub 2 g/100g 61197-0410-00 Pacifica 170 g — — FDA listed —
Zapzyt Acne Wash Cleanser 2 g/100g 71687-0007-01 Focus 188.5 g — — FDA listed —
Proven Acne Cleanser 2 g/100g 73572-0011-01 Proven 50 g — — FDA listed —
Acne Defense Spot Treatment Merle Norman 2 g/100g 57627-0201-02 Merle 1 tube — — FDA listed —
Clarifying Cleanser 2 g/100g 72957-0011-01 Private 203 g — — FDA listed —
Proven Acne Cleanser 2 g/100g 73572-0010-01 Proven 50 g — — FDA listed —
Tagrid Tinea Versicolor 2 g/100g 85384-0016-01 TAGRID 95.83 g — — FDA listed —
Shaant Hydrating Body Scrub 2 g/100g 83196-0785-12 Codex 1 tube — — FDA listed —
Acne Treatment Maximum Strength 2 g/100g 70631-0358-02 Young 1 tube — — FDA listed —
Shaant Pore Purifying Face Scrub 2 g/100g 83196-0676-12 Codex 1 tube — — FDA listed —
ES Salicylic Wash 2 g/100g 87702-0141-01 Elaine 200 g — — FDA listed —
AL0076001 Alba Botanica Acnedote Deep Pore Wash 2 g/100g 61995-2060-06 The 177 g — — FDA listed —
Orlaskin Salicylic Acid Acne Treatment Pads 2 g/100g 87582-0006-01 Guangzhou 80 patches — — FDA listed —
PCA Skin Acne Control Prebiotic Cleanser 2 g/100g 68726-0607-02 CP 1 bottle — — 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
Apr 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Salicylic Acid (matched by generic name) — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Salicylic Acid. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.2K
Claims incl. refills
43
Beneficiaries
35
Spend / beneficiary
$319.01
Spend / claim
$259.66
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Kenkoderm Psoriasis Moisturizing (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Age at onset

Neonate7
Infant1
Child8
Adolescent5
Adult170
Elderly94

Reporter sex

1,853 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Death611
Life-threatening174
Disabling124
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 252 0
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 NDCDescription Marketing startStatus
85286-0004-01 You're viewing this 295 g in 1 JAR (85286-004-01) 2025-04-02 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 85286-004-01, 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: 85286-0004-01, written without dashes as 85286000401. 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 85286-0004-01, the first segment (85286) is the labeler code FDA assigned to Nexgel,Inc.; the middle segment (0004) 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 Nexgel,Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Nexgel,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 24 words ▾

Uses For the relief of skin itching, scaling, redness, flaking and inflammation associated with psoriasis. Helps prevent the recurrence of the symptoms of psoriasis.

⏱️ Dosage and Administration 16 words ▾

Directions Apply to affected areas one to four times daily or as directed by a doctor.

⚠️ Warnings 87 words ▾

Warnings For external use only Ask a doctor before use if you have: a condition that covers a large area of the body an allergy or sensitivity to Salicylic Acid Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient Salicylic Acid 2.0%

🧪 Inactive Ingredients 55 words ▾

Inactive ingredients Water (Aqua), Urea, Propylene Glycol, Glyceryl Stearate SE, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Limnanthes Alba (Meadowfoam) Seed Oil, Glycerin, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Behentrimonium Methosulfate, Sodium Hyaluronate, Niacinamide, Ceramide NP, Ceramide AP, Ceramide EOP, Tocopherol, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Dimethicone, Carbomer, Xanthan Gum, Phenoxyethanol, Disodium EDTA, Ethylhexylglycerin, Sodium Hydroxide

🎯 Purpose 2 words ▾

Purpose Psoriasis

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85286-0003-01 · Nexgel,Inc. 85287-0011-02 · PICTON →
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.