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Dr. Sheffield Psoriasis Medicated Moisturizer 20 mg/g Lotion — NDC 11527-0478-64 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dr. Sheffield Psoriasis Medicated Moisturizer 20 mg/g Lotion — NDC 11527-478-64 (Billing 11527-0478-64)

by Sheffield Pharmaceuticals LLC · 1 TUBE in 1 CARTON / 28 g in 1 TUBE

This is a package of Dr. Sheffield Psoriasis Medicated Moisturizer 20 mg/g Lotion from Sheffield Pharmaceuticals LLC, marketed since Sep 2013 and currently FDA-listed. It is this product's only package size.

NDC 11527-0478-64
🏷️ FDA NDC (as labeled) 11527-478-64 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11527-478-64
Product NDC 11527-478
11-digit billing NDC 11527047864
RxCUI 103568
UNII O414PZ4LPZ
Application # M032
SPL Set ID 03739345-2ed2-4157-89e7-48926721815b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-09-01
Route TOPICAL
Dosage form LOTION
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 103568
Why two NDCs? The FDA registers this code as 11527-478-64 — 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 → 11527-0478-64. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It is used in a facial routine for acne-prone and oil-prone skin. The routine includes a cleanser, serum, toner and emulsion. Salicylic acid helps loosen and shed dead skin cells.
  • Use the cleanser morning and evening, and the serum in the morning after cleansing. Use the toner in the evening on dry skin, and the emulsion at night after cleansing. Avoid your...
  • Mild stinging, burning, itching, dryness and extra peeling can happen. If dryness or peeling bothers you, try using the serum or toner every other day. If it gets excessive, stop a...
  • It is best not to. Using another topical acne medication at the same time makes irritation and dryness more likely. If you get irritated, use only one at a time.
📖 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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
11527-0478-64 You're viewing this Main listing 1 TUBE in 1 CARTON / 28 g in 1 TUBE 2013-09-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
SkinMedica Acne Clarifying Treatment 20 mg/mL 00023-1230-01 Allergan, 1 tube — — FDA listed —
Ultra Clear Treatment 2 g/100mL 10028-0051-01 ULTRACEUTICALS 50 ml — — FDA listed —
Oxygenetix Oxygenating Foundation Acne Control 2 g/100mL 10258-0101-11 COLONIAL 15 ml — — Discontinued —
Dr. Sheffield Psoriasis Medicated Moisturizer 20 mg/gthis 11527-0478-64 Sheffield 1 tube — — FDA listed —
Meijer Oil Free Acne Wash Pink Grapefruit Foaming Scrub 20 mg/mL 41250-0963-15 MEIJER 198.1 ml — — FDA listed —
Daily Meds 20 mg/mL 49825-0100-10 Bioelements, 1 bottle — — FDA listed —
IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment 20 mg/mL 49967-0026-01 L'Oreal 1 bottle — — FDA listed —
Maybelline Dream Pure BB Beauty Balm 20 mg/mL 49967-0957-01 L'Oreal 30 ml — — FDA listed —
Clear Acne Face Moisturizer 28.8 mg/mL 50718-0033-01 Kamedis 1 bottle — — FDA listed —
ageLOC LumiSpa Blemish Serum 20 mg/mL 62839-2539-01 NSE 1 bottle — — FDA listed —
St. Ives Blemish and Blackhead Control Apricot Scrub .02 g/g 64942-1861-01 CONOPCO 22 g — — FDA listed —
Monat Be Clarified Acne-Clearing Moisturizer 20 mg/mL 68577-0107-00 Cosmax 1 bottle — — FDA listed —
Skin Pharmacy Advanced Acne Therapy Overnight Salicylic Acid 20 g/2mL 68634-0057-01 AMCOL 1 tube — — FDA listed —
Skinpharmacy Advanced Acne Therapy Overnight Salicylic Acid 20 mg/mL 69842-0066-01 CVS 1 tube — — FDA listed —
Clean and Clear Advantage Acne Spot Treatment 20 mg/mL 69968-0126-01 Kenvue 1 tube — — FDA listed —
LBRI PURE n NATURAL KlearAway 20 mg/mL 71238-0464-05 L'BRI 5 ml — — FDA listed —
Peace Out Acne Serum 20 mg/mL 71494-0102-30 Peace 1 bottle — — FDA listed —
amazon basics advanced blemish spot treatment Acne medication 20 mg/mL 72288-0386-01 AMAZON.COM 1 tube — — FDA listed —
SA Acne Spot Treatment 20 mg/g 73318-7003-09 Skin 1 bottle — — FDA listed —
Multi-Action Clear - Acne Clearing Treatment 2% Salicylic Acid 2 g/100mL 76147-0301-07 StriVectin 1 tube — — FDA listed —
Byoma Acne Control Body 20 mg/mL 84821-0004-01 Byoma 400 ml — — 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

🏛️
2013
On the market since
Sep 2013
📍
2026
Currently FDA-listed
13 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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 32MP823R8S
    A plant-derived ingredient from mugwort root, used in traditional herbal formulations. It may function as a flavoring agent, botanical extract, or natural additive in the medicine.
  • 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 5077EL0C60
    A plant extract from camellia leaves used in formulations as an antioxidant and skin-conditioning agent. It helps protect the product and its active ingredients from degradation.
  • UNII Z135WT9208
    Carbomer is a synthetic polymer that forms a thick, gel-like consistency. It's used in medicines as a thickener and stabilizer to improve texture and keep ingredients evenly mixed throughout the product.
  • 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 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 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 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII WH8T92A065
    A fatty acid derivative made by combining stearic acid with glycerin and citric acid. It acts as an emulsifier to help mix oil and water-based ingredients, and also serves as a thickener in the medicine formulation.
  • 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 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 6UYK2W1W1E
    A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
  • 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 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 CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII G025DAL7CE
    A plant extract from rhubarb root used as a natural colorant and flavoring agent in medicines. It may also help stimulate bowel movement in laxative formulations.
  • UNII JWB78P295A
    A plant extract from damask rose flowers used as a natural fragrance, flavoring agent, or coloring component in medicines. It adds pleasant aroma or taste to the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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 C32PQ86DH4
    Zinc PCA is a zinc salt of pyroglutamic acid, a naturally occurring amino acid derivative. It's used in medications as a skin-conditioning agent and to help maintain product stability and texture in topical formulations.

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

The official label also statesPurifed Water, Caprylic/Capric Triglyceride, Mineral Oil, Cetyl Alcohol, Butylene Glycol, Stearic Acid, Sodium Citrate, Glyceral Stearate, Triethanolamine, PEG-100 Sterate, Polysorbate 60, Phenoxyethanol, Carbomer, Zinc PCA, Panthenol, Camellia Oleifera leaf extract, Algea Extract, Artemisia Vulgaris Extract, Dipotassium Glycyrrhizate, Disodium EDTA, Rheum Palmatum Extract, Rosa Damascena Extract, Citric Acid, Methylparaben, Propylparaben, Dimethicone, Extra Virign Olea Europaea(Olive) Fruit oil

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.

Manufacturer & labeler

LabelerSheffield Pharmaceuticals LLC
FDA applicationM032 (OTC MONOGRAPH DRUG)
Labeler code11527
First marketedSep 2013
Product typeHuman Otc Drug
Portfolio29 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.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 16 words ▾

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

⏱️ Dosage and Administration 14 words ▾

Other information store at a controlled room temperature 68°-77°F ( 20°- 25°C) Questions? 1-800-222-1087

⚠️ Warnings 50 words ▾

Warnings For external use only Ask A doctor before use if condition covers a large area of the body. When using this product avoid contact with eyes. if contact occurs, rinse throughly with water. Stop use and ask a doctor if condition worsens or does not improve after regular use.

🧪 Active Ingredient 5 words ▾

Active Ingredient Salicylic Acid -2%

🧪 Inactive Ingredients 61 words ▾

Inactive ingredients Purifed Water, Caprylic/Capric Triglyceride, Mineral Oil, Cetyl Alcohol, Butylene Glycol, Stearic Acid, Sodium Citrate, Glyceral Stearate, Triethanolamine, PEG-100 Sterate, Polysorbate 60 , Phenoxyethanol, Carbomer, Zinc PCA, Panthenol, Camellia Oleifera leaf extract , Algea Extract, Artemisia Vulgaris Extract, Dipotassium Glycyrrhizate, Disodium EDTA, Rheum Palmatum Extract, Rosa Damascena Extract, Citric Acid, Methylparaben, Propylparaben, Dimethicone, Extra Virign Olea Europaea( Olive) Fruit oil

🎯 Purpose 5 words ▾

Purposes Psoriasis and seborrheic dermatitis

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Dr. Sheffield Psoriasis Medicated Moisturizer (this brand).

Top reported reactions

Application Site Pruritus1
Skin Discolouration1

Reporter sex

2 reports
Female · 100%
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 1 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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Sheffield Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sheffield Pharmaceuticals 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.
← 11527-0420-45 · Sheffield 11527-0704-42 · Sheffield →
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.