NDC 49967-0097-08 — SkinCeuticals Blemish Plus Age Defense Acne

🆔 Identity & classification

FDA NDC (as labeled) 49967-097-08

Product NDC 49967-097

11-digit billing NDC 49967009708

RxCUI 422997

UNII O414PZ4LPZ

Application # M006

SPL Set ID 5726d12c-708c-46e6-a584-9e5c7a544fc8

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2005-08-01

Route TOPICAL

Dosage form LOTION

Substance SALICYLIC ACID

Why two NDCs? The FDA registers this code as 49967-097-08 — 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 → 49967-0097-08. 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 marketedAug 2005

Product typeHuman Otc Drug

Portfolio197 products on file

🔎 All NDCs from L'Oreal USA Products Inc

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 →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

UNII 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 5F7PJF6AA4
A fatty acid derivative that combines salicylic acid with a plant-derived oil component. It acts as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in the medicine.
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 P7E6YFV72X
Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
UNII 0WT12SX38S
Glycolic acid is an alpha-hydroxy acid derived from sugar cane that helps dissolve and remove dead skin cells. In topical medicines, it works as an exfoliant and pH adjuster to improve skin penetration and product effectiveness.
UNII RWW266YE9I
A buffering agent derived from piperazine chemistry. It helps maintain stable pH levels in liquid medicines, particularly in injectable or ophthalmic formulations, preventing degradation of active ingredients.
UNII N8F53B3R4R
A synthetic humectant and solvent derived from propane. It draws and holds moisture in the formulation, helping keep the medicine stable and improving texture or flow in liquid and semi-solid products.
UNII 565ZMT5QRG
A long-chain fatty acid derived from plant oils, used as a binder and emulsifier to help hold ingredients together and improve texture in solid medications.
UNII 7ZNS52Y987
A synthetic polymer used as a film-former and thickening agent in topical formulations. It helps create a protective coating on skin or mucous membranes and improves product texture and consistency.
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
UNII 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.

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

The official label also statesalcohol denat., water, methylpropanediol, glycolic acid, diisopropyl adipate, octadecenedioic acid, hydroxethylpiperazine ethane sulfonic acid, citric acid, capryloyl salicylic acid, sodium hydroxide, polyquaternium-10

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price system	Per g	Per 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 15 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
ACNE solutions CLARIFYING 15 mg/mL 49527-0723-01	CLINIQUE	1 bottle	—	—	FDA listed	—
SkinCeuticals Blemish Plus Age Defense Acne Treatment 15 mg/mLthis 49967-0097-08	L'Oreal	6 vials	—	—	FDA listed	—
Kiehls Since 1851 Dermatologist Solutions Breakout Control Acne Treatment Facial 15 mg/mL 49967-0875-02	L'Oreal	5 ml	—	—	FDA listed	—
Clear Improvement Acne Clearing Hydrating Ltn 15 mg/mL 59427-0117-01	ORIGINS	1 bottle	—	—	FDA listed	—
Byoma Acne Control Moisturizer 15 mg/mL 84821-0006-01	Byoma	50 ml	—	—	FDA listed	—
Kiehls Since 1851 Blue Herbal Acne Cleanser Treatment with Frankincense and Ginger Root 15 mg/mL 49967-0086-01	L'Oreal	75 ml	—	—	FDA listed	—
Kiehls Since 1851 Blue Herbal Acne Cleanser Treatment 15 mg/mL 49967-0618-01	L'Oreal	75 ml	—	—	FDA listed	—
SkinCeuticals Blemish Plus Age Defense Acne Treatment 15 mg/mL 82046-0558-01	LOreal	1 bottle	—	—	FDA listed	—
Proactiv Blemish Control Body Cream 15 mg/mL 11410-0214-01	Alchemee,	1 tube	—	—	FDA listed	—
Thayers Natural Remedies Since 1847 Blemish Clearing Cleanser 15 mg/mL 49967-0070-01	LOreal	132 ml	—	—	FDA listed	—
Super Spot Remover Acne Treatment 15 mg/mL 59427-0005-01	ORIGINS	10 ml	—	—	FDA listed	—
SUNDAY RILEY U.F.O Acne Treatment Face Oil 15 mg/mL 73001-0460-05	Sunday	1 bottle	—	—	FDA listed	—

About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2005

On the market since

Aug 2005

📍

2026

Currently FDA-listed

21 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 Blemish Plus Age Defense 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

Male · 37%

Female · 63%

Unknown · 0%

Serious outcomes

Hospitalization623

Death611

Life-threatening174

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Marketing start	Status
49967-0097-05	1 BOTTLE, DROPPER in 1 CARTON (49967-097-05) / 30 mL in 1 BOTTLE, DROPPER	2005-08-01	Active
49967-0097-06	1 BOTTLE, DROPPER in 1 CARTON (49967-097-06) / 55 mL in 1 BOTTLE, DROPPER	2005-08-01	Active
49967-0097-07	1 BOTTLE, DROPPER in 1 CARTON (49967-097-07) / 15 mL in 1 BOTTLE, DROPPER	2005-08-01	Discontinued by firm
49967-0097-08 You're viewing this	6 VIAL in 1 CARTON (49967-097-08) / 4 mL in 1 VIAL	2005-08-01	Active

Pack size FAQ

What quantity is in NDC 49967-0097-08?

NDC 49967-0097-08 is listed by the FDA — 6 vial in 1 carton / 4 ml in 1 vial.

What NDC number is used to bill for this package of SkinCeuticals Blemish Plus Age Defense Acne Treatment Salicylic Acid 15 mg/mL Lotion?

Bill NDC 49967-0097-08 — the 11-digit billing format is 49967009708. 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 49967-097-08, 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: 49967-0097-08, written without dashes as 49967009708. 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 49967-0097-08, the first segment (49967) is the labeler code FDA assigned to L'Oreal USA Products Inc; the middle segment (0097) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 (49967-0097-05), 1 bottle (49967-0097-06), 1 bottle (49967-0097-07). 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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 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 1.5%

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients alcohol denat., water, methylpropanediol, glycolic acid, diisopropyl adipate, octadecenedioic acid, hydroxethylpiperazine ethane sulfonic acid, citric acid, capryloyl salicylic acid, sodium hydroxide, polyquaternium-10

🎯 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 ↗

🔗 Related NDC lookups

🧪 All Salicylic Acid NDCsSame ingredient 🏭 All L'Oreal labeler NDCsLabeler code 49967 📖 Read the Salicylic Acid drug informationUses, warnings & side effects