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CLARIFAST One Step Acne Treatment SALICYLIC ACID 5 mg/mL Cream, 81.33 mL — NDC 82908-0358-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CLARIFAST One Step Acne Treatment SALICYLIC ACID 5 mg/mL Cream, 81.33 mL — NDC 82908-358-00 (Billing 82908-0358-00)

by VIREO SYSTEMS, INC. · 81.33 mL in 1 JAR

This is a package of 81.33 mL of CLARIFAST One Step Acne Treatment SALICYLIC ACID 5 mg/mL Cream from VIREO SYSTEMS, INC., marketed since Aug 2022 and currently FDA-listed. It is this product's only package size.

NDC 82908-0358-00
🏷️ FDA NDC (as labeled) 82908-358-00 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 →

NDC database record

One package, one record: these facts belong to NDC 82908-358-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
82908 labeler · 358 product · 00 package
Package marketed since
Aug 8, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0349597001541
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 82908-358-00
Product NDC 82908-358
11-digit billing NDC 82908035800
RxCUI 248684
UNII O414PZ4LPZ
UPC 0349597001541
Application # M006
SPL Set ID b20a0f00-4bf2-4583-b399-7097542fff90
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-08-08
Route TOPICAL
Dosage form CREAM
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 248684
Why two NDCs? The FDA registers this code as 82908-358-00 — 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 → 82908-0358-00. 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

📖 What it is MedlinePlus · NLM

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 ↗
📗 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 →
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
82908-0358-00 You're viewing this Main listing 81.33 mL in 1 JAR 2022-08-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Proactiv Plus Complexion Perfecting Hydrator .5 g/100mL 11410-0023-00 Alchemee, 1 tube — — FDA listed —
Acne Advanced Clarifying Masque 5 mg/mL 15751-3020-02 Eminence 1 tube — — FDA listed —
Yes To Tomatoes Detoxifying Charcoal Sleeping Mask 5 mg/mL 69840-0008-08 Yes 4 ml — — FDA listed —
Neutrogena Skin Clearing Blemish Concealer - Light 10 5 mg/g 69968-0805-01 Kenvue 1 applicator — — FDA listed —
Neutrogena Skin Clearing Blemish Concealer - Fair 05 5 mg/g 69968-0810-01 Kenvue 1 applicator — — FDA listed —
Neutrogena Skin Clearing Blemish Concealer - Buff 09 5 mg/g 69968-0811-01 Kenvue 1 applicator — — FDA listed —
Neutrogena Skin Clearing Blemish Concealer - Medium 15 5 mg/g 69968-0812-01 Kenvue 1 applicator — — FDA listed —
Acne Fighting Foundation Caramel 5 mg/mL 70412-0435-01 Zhejiang 1 bottle — — FDA listed —
b pure Blemish Concealer for Acne Prone Skin Nude 5 mg/g 80684-0108-00 Fourstar 1.4 g — — FDA listed —
b pure Blemish Concealer for Acne Prone Skin Fair 5 mg/g 80684-0109-00 Fourstar 1.4 g — — FDA listed —
CLARIFAST One Step Acne Treatment 5 mg/mLthis 82908-0358-00 VIREO 81.33 ml — — FDA listed —
Vichy Laboratoires Normaderm Daily Gentle Cleanser 5 mg/mL 49967-0232-01 L'Oreal 125 ml — — FDA listed —
Vichy Laboratoires Normaderm Phytoaction Daily Deep Cleansing 5 mg/mL 49967-0307-01 L'Oreal 200 ml — — FDA listed —
enfuselle Acne Clarifying 5 mg/mL 59899-0002-01 Shaklee 1 tube — — FDA listed —
Vichy Laboratoires Normaderm Phytoaction Deep Cleansing 5 mg/mL 69625-0306-01 COSMETIQUE 200 ml — — FDA listed —
Peach and Lily Peaches Slices Acne Oil Acne Free Moisturizer 5 mg/mL 81515-0502-01 Peach 80 ml — — FDA listed —
ClearSynergy 5 mg/mL 71617-0102-01 SRL 150 ml — — FDA listed —
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment 5 mg/mL 49967-0630-01 L'Oreal 200 ml — — FDA listed —
Aveeno Positively Radiant Clear Complexion Daily Moisturizer 5 mg/mL 69968-0928-04 Kenvue 1 bottle — — FDA listed —
Meijer Foaming Cleanser Acne medication 5 mg/mL 41250-0354-01 Meijer 177 ml — — FDA listed —
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment 5 mg/mL 69625-0630-01 COSMETIQUE 200 ml — — FDA listed —
Clean and Clear Essentials Dual Action Moisturizer 5 mg/mL 69968-0803-04 Kenvue 118 ml — — FDA listed —
Neutrogena Oil Free Acne Moisturizer Pink Grapefruit 5 mg/mL 69968-0193-01 Kenvue 14 ml — — FDA listed —
Target Up and Up Moisturizer with Salicylic Acid Acne Treatment 5 mg/mL 82442-0016-13 TARGET 118 ml — — FDA listed —
Cetaphil Gentle Clear Mattifying Acne Moisturizer 5 mg/mL 00299-4117-00 Galderma 1 tube — — FDA listed —
Neutrogena Stubborn Blackheads Daily Serum 5 mg/mL 69968-0703-01 Kenvue 1 tube — — FDA listed —
Dapinaq 5 mg/mL 87110-0002-01 METHODIQ 1 bottle — — FDA listed —
Azelaq 5 mg/mL 87110-0003-01 METHODIQ 1 bottle — — FDA listed —
ageLOC LumiSpa Treatment Cleanser Acne 5 mg/mL 62839-1495-01 NSE 100 ml — — FDA listed —
MDacne Customized Acne Cleanser Hydrating Salicylic Acid 5 mg/mL 71804-0534-00 MDAlgorithms 59 ml — — FDA listed —
Neutrogena Evenly Clear Acne Exfoliant 5 mg/mL 69968-0944-01 Kenvue 1 bottle — — FDA listed —
Aveeno clear complexion daily moisturizer 5 mg/mL 69968-0372-04 Kenvue 1 bottle — — FDA listed —
Aveeno Positively Radiant Clear Complexion Daily Moisturizer 5 mg/mL 69968-0738-04 Kenvue 1 bottle — — FDA listed —
PuraClear Advanced Skincare Acne Moisturizer 5 mg/mL 88016-0017-00 PuraClear 118 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

🏛️
2022
On the market since
Aug 2022
📍
2026
Currently FDA-listed
4 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.

🧪 Avoiding an ingredient? See Salicylic Acid Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 26I94X9A1K
    Bellis perennis flower is an extract from the common daisy plant. It's used in medicines as a natural flavoring agent and may help improve the taste or aroma of 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 Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII CI71S98N1Z
    A mineral salt containing potassium and phosphate, used as a buffer to help maintain the medicine's pH level and stability during storage.
  • 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 8PI54V663Y
    Oatmeal is ground oat grain used as a natural filler and texture agent in medicines. It absorbs moisture, adds bulk to the formulation, and may help create a soothing base in topical products.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 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 SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

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

The official label also statesAlpha-GEE®, Aloe Barbadensis Leaf Extract, Amezol®, Bellis Perennis Flower Extract, Cetyl Alcohol, Coconut Oil, Colloidal Oatmeal,  Denatured  Alcohol, Glyceryl Monostearate, Hamamelis Virginiana Extract 3X, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Polyethylene Glycol 400, Polyethylene Glycol 3350, Potassium Phosphate Dibasic, Propylene Glycol, Sulfur 1X, Zinc Oxide.

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

LabelerVIREO SYSTEMS, INC.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code82908
First marketedAug 2022
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.

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 51 words ▾

Uses: • For the treatment of acne. • Helps clear acne blemishes, pimples, and blackheads. • Penetrates pores to reduce the number of acne blemishes, pimples and blackheads. • Helps prevent new acne blemishes, pimples, and blackheads from forming. • Helps prevent the development of new acne blemishes, pimples and blackheads.

⏱️ Dosage and Administration 51 words ▾

Directions: • Apply to affected area and rub in lightly, one to two times daily (before bedtime or anytime during the day as desired). Allow 30 minutes to dry • If drying of the skin occurs, reduce application to once a day, every other day, or as directed by a doctor.

⚠️ Warnings 70 words ▾

Warnings: for external use only. When using this product: Skin irritation and dryness is 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. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

🧪 Active Ingredient 9 words ▾

Active ingredient Salicylic Acid 0.5 % Purpose Acne Treatment

🧪 Inactive Ingredients 47 words ▾

Inactive ingredients: Alpha-GEE®, Aloe Barbadensis Leaf Extract, Amezol®, Bellis Perennis Flower Extract, Cetyl Alcohol, Coconut Oil, Colloidal Oatmeal, Denatured Alcohol, Glyceryl Monostearate, Hamamelis Virginiana Extract 3X, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Polyethylene Glycol 400, Polyethylene Glycol 3350, Potassium Phosphate Dibasic, Propylene Glycol, Sulfur 1X, Zinc Oxide.

🎯 Purpose 3 words ▾

Purpose Acne Treatment

📄 When Using This Product 36 words ▾

When using this product: Skin irritation and dryness is 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.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 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.

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Label2

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 VIREO SYSTEMS, INC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
VIREO SYSTEMS, 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.
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.