HomeNDC LookupIngredientsSalicylic Acid › 49967-0068-03
SkinCeuticals Silymarin CF Acne Treatment Salicylic Acid 5 mg/mL Solution — NDC 49967-0068-03 package photo

SkinCeuticals Silymarin CF Acne Treatment Salicylic Acid 5 mg/mL Solution

by L'Oreal USA Products Inc · 1 BOTTLE in 1 CARTON (49967-068-03) / 15 mL in 1 BOTTLE
NDC 49967-0068-03
🏷️ FDA NDC (as labeled) 49967-068-03 billing pads the product segment with a zero
This package
Contains15 mL in 1 bottle Pack sizes4 compare ↓
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 →

🆔 Identity & classification

FDA NDC (as labeled) 49967-068-03
Product NDC 49967-068
11-digit billing NDC 49967006803
RxCUI 199308
UNII O414PZ4LPZ
UPC 3606000522435
Application # M006
SPL Set ID aa439d77-7ba5-4699-8e8b-3bba35f5094d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-12-31
Route TOPICAL
Dosage form SOLUTION
Substance SALICYLIC ACID
Why two NDCs? The FDA registers this code as 49967-068-03 — 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 → 49967-0068-03. 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

LabelerL'Oreal USA Products Inc
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code49967
First marketedDec 2020
Product typeHuman Otc Drug
Portfolio197 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

📖 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'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 →
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 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 PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII E107L85C40
    Dipropylene glycol is a clear liquid made from propylene glycol. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII AVM951ZWST
    Ferulic acid is a naturally occurring plant compound used as an antioxidant in medications. It helps prevent ingredient breakdown and maintain product stability during storage.
  • UNII N72LMW566G
    A synthetic cleansing agent derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oil and water-based ingredients in liquid medicines, acting as an emulsifier and solubilizer.
  • UNII U946SH95EE
    Milk thistle is a plant extract used in some supplements and herbal formulations. It may act as an active botanical ingredient rather than a traditional inactive excipient, though it can also serve as a filler or binder in tablet or capsule preparations.
  • 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 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 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.

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

The official label also stateswater, alcohol denat., ascorbic acid, propylene glycol, dipropylene glycol, laureth-23, silybum marianum fruit extract, sodium citrate, ferulic acid

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 DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 mL 55 mL 10 vials
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
Cetaphil Gentle Clear Triple-Action Acne Serum 5 mg/mL 00299-4135-00 Galderma 1 tube FDA listed
Oxy Total Care Vitamin C Serum 5 mg/mL 10742-1315-01 The 1 vial FDA listed
Up and Up Deep Clean Toner 5 mg/mL 11673-0936-11 TARGET 236.5 ml FDA listed
Salicylic Acid 5 mg/mL 36800-0875-34 Topco 237 ml FDA listed
Even Better Clinical Acne Solutions 5 mg/mL 49527-0114-01 CLINIQUE 1 bottle FDA listed
ACNE solutions liquid MAKEUP SALICYLIC ACID ACNE TREATMENT 5 mg/mL 49527-0751-01 CLINIQUE 1 bottle Discontinued
La Roche Posay Laboratoire Dermatologique Effaclar Clarifying 5 mg/mL 49967-0024-01 L'Oreal 200 ml FDA listed
SkinCeuticals Silymarin CF Acne Treatment 5 mg/mLthis 49967-0068-03 L'Oreal 1 bottle FDA listed
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment 5 mg/mL 49967-0926-01 L'Oreal 1 tube FDA listed
Salicylic Acid 5 mg/mL 55301-0875-34 Your 237 ml Discontinued
Nutricentials Here You Glow Exfoliating Toner 5 mg/mL 62839-1339-01 NSE 150 ml FDA listed
Clear Smart Clear Complexion Toner .5 g/100mL 68828-0289-01 Distribuidora 200 ml FDA listed
In the Clear Acne Serum .5 g/100mL 69366-0414-31 The 1 bottle FDA listed
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment 5 mg/mL 69625-0058-01 COSMETIQUE 15 tubes FDA listed
SkinCeuticals Silymarin CF Acne Treatment Antioxidant 5 mg/mL 69625-0069-01 Cosmetique 1 bottle FDA listed
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment 5 mg/mL 69625-0926-01 COSMETIQUE 1 tube FDA listed
Neutrogena Skin Clearing Blemish Concealer - Deep 20 5 mg/g 69968-0338-01 Kenvue 1 vial FDA listed
Neutrogena SkinClearing Oil-Free Makeup - Classic Ivory 10 5 mg/mL 69968-0853-01 Kenvue 30 ml FDA listed
Neutrogena SkinClearing Oil-Free Makeup - Natural Ivory 20 5 mg/mL 69968-0854-01 Kenvue 30 ml FDA listed
Neutrogena SkinClearing Oil-Free Makeup - Buff 30 5 mg/mL 69968-0855-01 Kenvue 30 ml FDA listed
Neutrogena SkinClearing Oil-Free Makeup - Nude 40 5 mg/mL 69968-0856-01 Kenvue 30 ml FDA listed
Neutrogena SkinClearing Oil-Free Makeup - Soft Beige 50 5 mg/mL 69968-0857-01 Kenvue 30 ml FDA listed
Neutrogena SkinClearing Oil-Free Makeup - Natural Beige 60 5 mg/mL 69968-0858-01 Kenvue 30 ml FDA listed
Neutrogena SkinClearing Oil-Free Makeup - Fresh Beige 70 5 mg/mL 69968-0859-01 Kenvue 30 ml FDA listed
Neutrogena SkinClearing Oil-Free Makeup- Medium Beige 80 5 mg/mL 69968-0860-01 Kenvue 30 ml FDA listed
Neutrogena SkinClearing Oil-Free Makeup - Honey 85 5 mg/mL 69968-0861-01 Kenvue 30 ml FDA listed
Neutrogena SkinClearing Oil-Free Makeup - Warm Beige 90 5 mg/mL 69968-0862-01 Kenvue 30 ml FDA listed
Neutrogena SkinClearing Oil-Free Makeup- Natural Tan 100 5 mg/mL 69968-0863-01 Kenvue 30 ml FDA listed
Neutrogena SkinClearing Oil-Free Makeup - Caramel 105 5 mg/mL 69968-0864-01 Kenvue 30 ml FDA listed
Neutrogena SkinClearing Oil-Free Makeup - Cocoa 115 5 mg/mL 69968-0865-01 Kenvue 30 ml FDA listed
Neutrogena SkinClearing Oil-Free Makeup - Chestnut 135 5 mg/mL 69968-0866-01 Kenvue 30 ml FDA listed
Clearsynergy .25 g/50mL 71617-0100-10 SRL 1 bottle FDA listed
FHF Crisp Start .5 g/100g 72788-0151-03 Summer 1 tube FDA listed
Dr. C. Tuna Acne Pore Purifying Toner 5 mg/mL 74690-0009-01 Farmasi 1 bottle FDA listed
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment 5 mg/mL 82046-0058-01 L'Oreal 15 tubes FDA listed
Ogee Clearganics Targeted Blemish Treatment .5 g/100mL 84261-0154-01 Ogee 10 ml FDA listed
Skinpharmacy Advanced Acne Therapy Pore Refining Facial Mask 5 mg/mL 69842-0077-01 CVS 1 tube FDA listed
Even and Clear Cleanser 5 mg/mL 73453-0003-01 Ambi 177 ml FDA listed
Aveeno CLEAR COMPLEXION foaming cleanser 5 mg/mL 69968-0471-06 Kenvue 177 ml FDA listed
Derma Pella Acne Wash for Oily Skin 5 mg/mL 82160-0764-01 Pella 150 ml Discontinued
Aveeno Positively Radiant Clear Complexion Foaming Cleanser 5 mg/mL 69968-0769-06 Kenvue 177 ml FDA listed
Breakout Clearing Foaming Wash 5 mg/mL 68479-0101-00 Dermalogica 2 ml FDA listed
Deep Cleaning Astringent 5 mg/mL 41250-0775-34 Meijer, 237 ml Discontinued
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

🏛️
2020
On the market since
Dec 2020
📍
2026
Currently FDA-listed
6 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.

📊 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 SkinCeuticals Silymarin CF Acne Treatment (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

Hospitalization623
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 243 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
49967-0068-01 1 BOTTLE in 1 CARTON (49967-068-01) / 30 mL in 1 BOTTLE 2021-01-01 Active
49967-0068-02 1 BOTTLE in 1 CARTON (49967-068-02) / 55 mL in 1 BOTTLE 2021-01-01 Active
49967-0068-03 You're viewing this 1 BOTTLE in 1 CARTON (49967-068-03) / 15 mL in 1 BOTTLE 2021-01-01 Active
49967-0068-04 10 VIAL in 1 CARTON (49967-068-04) / 4 mL in 1 VIAL 2021-01-01 Active

Pack size FAQ

What quantity is in NDC 49967-0068-03?
NDC 49967-0068-03 is listed by the FDA — 1 bottle in 1 carton / 15 ml in 1 bottle.
What NDC number is used to bill for this package of SkinCeuticals Silymarin CF Acne Treatment Salicylic Acid 5 mg/mL Solution?
Bill NDC 49967-0068-03 — the 11-digit billing format is 49967006803. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 49967-068-03, 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: 49967-0068-03, written without dashes as 49967006803. 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 49967-0068-03, the first segment (49967) is the labeler code FDA assigned to L'Oreal USA Products Inc; the middle segment (0068) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 L'Oreal USA Products Inc. 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 3 other package presentations of this same product, including 1 bottle (49967-0068-01), 1 bottle (49967-0068-02), 10 vials (49967-0068-04). 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?
L'Oreal USA Products 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 21 words

Uses - for the treatment of acne - reduces the number and severity of acne blemishes and allows skin to heal

⏱️ Dosage and Administration 73 words

Directions - 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

⚠️ Warnings 5 words

Warnings For external use only

📦 Storage and Handling 8 words

Other information store in a cool, dark place

🧪 Active Ingredient 5 words

Active ingredient Salicylic acid 0.5%

🧪 Inactive Ingredients 20 words

Inactive ingredients water, alcohol denat., ascorbic acid, propylene glycol, dipropylene glycol, laureth-23, silybum marianum fruit extract, sodium citrate, ferulic acid

🎯 Purpose 3 words

Purpose Acne treatment

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