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Perricone MD Acne Relief Calming Treatment and Hydrator Salicylic Acid .5 g/100mL Cream — NDC 84448-0540-21 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Perricone MD Acne Relief Calming Treatment and Hydrator Salicylic Acid .5 g/100mL Cream — NDC 84448-540-21 (Billing 84448-0540-21)

by THG Beauty USA LLC · 1 TUBE in 1 CARTON / 21 mL in 1 TUBE

This is a package of Perricone MD Acne Relief Calming Treatment and Hydrator Salicylic Acid .5 g/100mL Cream from THG Beauty USA LLC, marketed since Sep 2024 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 84448-0540-21
🏷️ FDA NDC (as labeled) 84448-540-21 billing pads the product segment with a zero
This package
Contains21 mL in 1 tube Pack sizes2 compare ↓
Main listing for product 84448-540 · Also comes in: 59 mL 84448-540-59
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 →

NDC database record

One package, one record: these facts belong to NDC 84448-540-21 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84448 labeler · 540 product · 21 package
Package marketed since
Sep 12, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0604079161961
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84448-540-21
Product NDC 84448-540
11-digit billing NDC 84448054021
UNII O414PZ4LPZ
UPC 0604079161961
Application # M006
SPL Set ID 21eafafe-18ea-08d3-e063-6294a90abb85
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-09-12
Route TOPICAL
Dosage form CREAM
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 84448-540-21 — 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 → 84448-0540-21. 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.

Clinical

🧪 What is this product?

This is a topical cream containing salicylic acid, marketed as an over-the-counter monograph product under FDA regulation. Salicylic acid is commonly used in skin-care products to help exfoliate the outer layer of skin and is typically included in treatments intended for acne-prone or oily complexions. The product is applied directly to the skin and is formulated to combine acne-relief action with moisturizing properties.

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.
Try another pack size: 59 mL
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
84448-0540-21 You're viewing this Main listing 1 TUBE in 1 CARTON / 21 mL in 1 TUBE 2024-09-12 — Active
84448-0540-59 84448-540-59 1 BOTTLE, DROPPER in 1 CARTON / 59 mL in 1 BOTTLE, DROPPER 2024-09-12 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 tube in 1 carton / 21 ml in 1 tube.
What NDC number is used to bill for this package of Perricone MD Acne Relief Calming Treatment and Hydrator Salicylic Acid .5 g/100mL Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Creamy Foam Cleanser .5 g/100mL 82870-0002-01 Dime 120 ml — — FDA listed —
Perricone MD Acne Relief Retinol Treatment and Moisturizer .5 g/100mL 84448-0537-21 THG 1 tube — — FDA listed —
Proactiv Blackhead Dissolving .5 g/100mL 11410-0024-05 Alchemee, 1 tube — — FDA listed —
Perricone MD Acne Relief Calming Treatment and Hydrator Salicylic Acid Acne Treatment .5 g/100mLthis 84448-0540-21 THG 1 tube — — FDA listed —
Gentle Acne Serum .5 g/100mL 83286-0016-01 Drmtlgy, 59 ml — — FDA listed —
Ultra Clear Foaming Cleanser .5 g/100mL 10028-0050-01 ULTRACEUTICALS 150 ml — — FDA listed —
Clear Smart Charcoal Blackhead Scrub .5 g/100mL 68828-0001-01 Distribuidora 1 tube — — FDA listed —
Proactiv Plus Complexion Perfecting Hydrator .5 g/100mL 11410-0023-00 Alchemee, 1 tube — — FDA listed —
Scrub So Clean Acne-Fighting Super Scrub .5 g/100mL 70626-0107-11 ASPIRE 100 ml — — FDA listed —
Purifying Clay Mask .5 g/100mL 56152-5012-01 Cosmetic 88 ml — — FDA listed —
Clear Smart Clear Pore Hydrator .5 g/100mL 68828-0701-01 Distribuidora 50 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

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII GC844VRD7E
    A synthetic fatty acid ester derived from plant oils and lactic acid. It acts as an emulsifier and solvent to help mix oil and water-based ingredients and improve how the medicine dissolves or spreads in the body.
  • UNII E4F12ROE70
    A refined mineral oil derived from crude petroleum containing 13 to 14 carbon chains. It acts as a solvent, emollient, and carrier in topical formulations to help dissolve active ingredients and improve product texture and spreadability.
  • UNII 29VT07BGDA
    Citrulline is an amino acid compound used as a buffer and pH adjuster in medications. It helps maintain the proper acidity level of the formulation for stability and 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 H895X08VNQ
    A silicone-based polymer that forms small, hard particles. It acts as a glidant and anti-caking agent to improve powder flow and prevent clumping in tablets and capsules.
  • 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 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII Z95S6G8201
    A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
  • 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 9FPL31B58Q
    A synthetic polymer made by linking acrylamide chains together. It acts as a thickener and absorbent in formulations, helping control texture and stability of gels, creams, or liquid medicines.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII AB6MNQ6J6L
    Succinic acid is an organic acid derived from natural sources or chemical synthesis. In medications, it functions as a buffer to help maintain the proper pH level and may also serve as a preservative or flavor enhancer in formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesWater/Aqua/Eau, SD Alcohol 40-B, Glycerin, C12-15 Alkyl Lactate, PVP, Dimethicone, Polysorbate 20, Citrulline, Squalane, Lactic Acid, Succinic Acid, Polyacrylamide, Dimethicone/Vinyl Dimethicone Crosspolymer, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate

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

LabelerTHG Beauty USA LLC
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code84448
First marketedSep 2024
Product typeHuman Otc Drug
Portfolio18 products on file

More NDCs from THG Beauty USA LLC labeler code 84448

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 6 words ▾

■ For the treatment of acne

⏱️ Dosage and Administration 129 words ▾

Directions ■ Shake well. Apply a thin, even layer to skin in the morning. For best results, use after cleansing with ACNE RELIEF Gentle & Soothing Cleanser. ■ Clean the skin thoroughly before applying this product. ■ Cover the entire affected area with a thin layer one to three times daily. ■ Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. ■ If bothersome dryness or peeling occurs, reduce application to once a day or every other day. ■ Sensitivity Test for a New User Apply product sparingly to one or two small affected areas during the first 3 days.

If no discomfort occurs, follow the directions sta

⚠️ Warnings 4 words ▾

For external use only

🧪 Active Ingredient 3 words ▾

Salicylic Acid 0.5%

🧪 Inactive Ingredients 30 words ▾

Water/Aqua/Eau, SD Alcohol 40-B, Glycerin, C12-15 Alkyl Lactate, PVP, Dimethicone, Polysorbate 20, Citrulline, Squalane, Lactic Acid, Succinic Acid, Polyacrylamide, Dimethicone/Vinyl Dimethicone Crosspolymer, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate

🎯 Purpose 2 words ▾

Acne Treatment

📄 When Using This Product 37 words ▾

When Using This Product skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. ■ If irritation occurs, only use one topical acne medication at a time

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Questions or Comments 1 words ▾

1-888-823-7837

📄 Package Label / Principal Display Panel 7 words ▾

59mL 90 Day Regimen 30 Day Regimen

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

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.

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 THG Beauty USA LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (84448-0540-59). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
THG Beauty USA 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.
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.