NDC 76354-0415-01 — Acne Clarifying Cleanser SALICYLIC ACID 10

🆔 Identity & classification

FDA NDC (as labeled) 76354-415-01

Product NDC 76354-415

11-digit billing NDC 76354041501

RxCUI 1038982

UNII O414PZ4LPZ

Application # M006

SPL Set ID 0e9be1e3-7fa9-4d70-9c89-cf7501d2380b

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2022-02-25

Route TOPICAL

Dosage form LIQUID

Substance SALICYLIC ACID

Why two NDCs? The FDA registers this code as 76354-415-01 — 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 → 76354-0415-01. 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

Labelere.l.f. Cosmetics, Inc.

FDA applicationM006 (OTC MONOGRAPH DRUG)

Labeler code76354

First marketedFeb 2022

Product typeHuman Otc Drug

Portfolio158 products on file

🔎 All NDCs from e.l.f. Cosmetics, 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

📗 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 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 5OCF3O11KX
A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
UNII 8NLQ36F6MM
Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
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 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII 25X51I8RD4
Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
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 O9W3D3YF5U
A synthetic surfactant derived from petroleum-based olefins. It helps dissolve or suspend active ingredients and other substances in liquid formulations, improving how the medicine mixes and flows.
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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 6T84R30KC1
Tranexamic acid is a synthetic compound that helps reduce bleeding by slowing the breakdown of blood clots. In medicines, it acts as an active pharmaceutical ingredient rather than an inactive filler, and is included to provide therapeutic effects related to bleeding control.
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.

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

The official label also statesWater (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Glycerin, Zinc PCA, Sodium Benzoate, Hydroxypropyl Methylcellulose, Sodium Hydroxide, Sodium Chloride, Citric Acid, Disodium EDTA, Niacinamide, Tranexamic Acid May Contain: Blue 1 (CI 42090), Yellow 5 (CI 19140)

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 mL	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

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
Proactivplus Smoothing BHA Cleanser 10 mg/mL 11410-0216-01	Alchemee,	1 tube	—	—	FDA listed	—
Acne Advanced Cleansing 10 mg/mL 15751-3010-05	Eminence	1 bottle	—	—	FDA listed	—
Nas Pore Refining Scrub 1 g/100g 26052-0040-01	BURT'S	110 g	—	—	FDA listed	—
blackhead solutions 7 day deep pore cleanse and scrub acne medication 10 mg/mL 49527-0062-02	CLINIQUE	1 tube	—	—	Discontinued	—
clear days ahead oil-free salicylic acid acne treatment cleanser 2.4 g/240mL 50184-1005-01	Philosophy	240 ml	—	—	FDA listed	—
Sei Bella Clarity Clear Refining Foaming Cleanser Acne treatment 1.8 g/180mL 54473-0401-01	Melaleuca,	180 ml	—	—	FDA listed	—
Acne wash facial cleanser pink grapefruit 2 g/200mL 57337-0080-01	Rejoice	200 ml	—	—	FDA listed	—
Acne wash facial cleanser Tea tree oil 2 g/200mL 57337-0081-01	Rejoice	200 ml	—	—	FDA listed	—
Clear Improvement Blackhead Clearing Mask To Scrub 10 mg/mL 59427-0118-01	ORIGINS	75 ml	—	—	FDA listed	—
Dove 1 g/100mL 64942-2074-01	CONOPCO	512 ml	—	—	FDA listed	—
Dove 1 g/100mL 64942-2093-01	CONOPCO	500 ml	—	—	Discontinued	—
Neutrogena Stubborn Texture Daily Cleanser 10 mg/mL 69968-0704-06	Kenvue	186 ml	—	—	FDA listed	—
Neutrogena Stubborn Body Acne Cleanser and Exfoliator 10 mg/mL 69968-0759-08	Kenvue	250 ml	—	—	FDA listed	—
NAELI Exfoliator AHA-BHA Face Cleanser 10 mg/mL 73670-0606-00	ALLI	1 bottle	—	—	FDA listed	—
NAELI Exfoliator AHA BHA Face Cleanser 10 mg/mL 73670-0620-00	ALLI	1 bottle	—	—	FDA listed	—
Acne Clarifying Cleanser 10 mg/mLthis 76354-0415-01	e.l.f.	1 bottle	—	—	FDA listed	—
Acne Wash 1 mg/100mg 82442-0805-01	Target	650 mg	—	—	FDA listed	—
bareMinerals Blemish Remedy Acne Treatment Gelee Cleanser 10 mg/g 98132-0770-01	Orveon	1 tube	—	—	FDA listed	—
ARTISTRY STUDiO Rose All Day Anti Acne Toner Pore Refresher 10 mg/mL 10056-0410-00	Access	200 ml	—	—	FDA listed	—
Dr. C. Tuna Acne Blemish Control Serum 10 mg/mL 74690-0011-01	Farmasi	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

🏛️

2022

On the market since

Feb 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.

📊 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 SALICYLIC ACID — the ingredient across all brands.

Top reported reactions

Dry Skin12,766

Erythema12,318

Acne11,763

Skin Burning Sensation11,557

Skin Irritation7,730

Skin Exfoliation5,759

Rash4,766

Age at onset

Neonate7

Infant1

Child16

Adolescent30

Adult334

Elderly131

Reporter sex

Male · 27%

Female · 73%

Unknown · 0%

Serious outcomes

Hospitalization800

Life-threatening214

Disabling147

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
76354-0415-01 You're viewing this	1 BOTTLE in 1 CARTON (76354-415-01) / 115 mL in 1 BOTTLE	2022-02-25	Active
76354-0415-02	1 BOTTLE in 1 CARTON (76354-415-02) / 30 mL in 1 BOTTLE	2022-02-25	Active

Pack size FAQ

What quantity is in NDC 76354-0415-01?

NDC 76354-0415-01 is listed by the FDA — 1 bottle in 1 carton / 115 ml in 1 bottle.

What NDC number is used to bill for this package of Acne Clarifying Cleanser SALICYLIC ACID 10 mg/mL Liquid?

Bill NDC 76354-0415-01 — the 11-digit billing format is 76354041501. 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 76354-415-01, 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: 76354-0415-01, written without dashes as 76354041501. 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 76354-0415-01, the first segment (76354) is the labeler code FDA assigned to e.l.f. Cosmetics, Inc.; the middle segment (0415) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 e.l.f. Cosmetics, 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 1 other package presentation of this same product, including 1 bottle (76354-0415-02). 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?

e.l.f. Cosmetics, 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 11 words ▾

Uses For the treatment of acne Helps prevent new acne blemishes

⏱️ Dosage and Administration 101 words ▾

Directions Cleanse the skin thoroughly before applying medication. 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 stated eleswhere on this label.

⚠️ Warnings 60 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.

🧪 Active Ingredient 8 words ▾

Active ingredients Salicylic Acid 1% Purpose Acne Treatment

🧪 Inactive Ingredients 38 words ▾

Inactive ingredients Water (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Glycerin, Zinc PCA, Sodium Benzoate, Hydroxypropyl Methylcellulose, Sodium Hydroxide, Sodium Chloride, Citric Acid, Disodium EDTA, Niacinamide, Tranexamic Acid May Contain: Blue 1 (CI 42090), Yellow 5 (CI 19140)

🎯 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 e.l.f. labeler NDCsLabeler code 76354 📖 Read the Salicylic Acid drug informationUses, warnings & side effects