Home › NDC Lookup › Ingredients › Salicylic Acid, Benzoyl Peroxide › 80861-0007-01
Acne Free SENSITIVE SKIN 24 HR Acne Clearing System SALICYLIC ACID, BENZOYL PEROXIDE Kit — NDC 80861-0007-01 package photo

Acne Free SENSITIVE SKIN 24 HR Acne Clearing System SALICYLIC ACID, BENZOYL PEROXIDE Kit

by AcneFree LLC · 1 KIT in 1 KIT (80861-007-01) * 118 mL in 1 BOTTLE (80861-008-01) * 59 mL in 1 BOTTLE (80861-009-01)
NDC 80861-0007-01
🏷️ FDA NDC (as labeled) 80861-007-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 80861-007-01
Product NDC 80861-007
11-digit billing NDC 80861000701
RxCUI 1234456, 1548871, 1549098
UPC 0850004234471
Application # M006
SPL Set ID c9397a25-8fed-48d0-e053-2a95a90ab495
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-12-01
Dosage form KIT
Why two NDCs? The FDA registers this code as 80861-007-01 — 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 → 80861-0007-01. 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

LabelerAcneFree LLC
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code80861
First marketedDec 2017
Product typeHuman Otc Drug
Portfolio3 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

📖 About the active ingredient: Salicylic Acid, Benzoyl Peroxide MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Benzoyl peroxide is used to treat mild to moderate acne.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an over-the-counter acne clearing kit containing salicylic acid and benzoyl peroxide, two topical agents commonly used in acne skincare systems. Salicylic acid is typically used to help unclog pores and reduce excess skin buildup, while benzoyl peroxide is commonly used to help reduce acne-causing bacteria on the skin. The kit is formulated for sensitive skin and is marketed as an over-the-counter monograph product, meaning it follows established FDA guidelines for acne treatments in this category.

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.

From the label’s inactive-ingredient sectionwater, sodium cocoyl isethionate, stearic acid, cocamidopropyl betaine, sodium lauroamphoacetate, disodium laureth sulfosuccinate, glycol distearate, polyacrylate-1 crosspolymer, benzyl alcohol, avena sativa (oat) kernel extract, sodium phytate, zinc PCA, glycerin, sorbic acid, ethyl vanillin, butylene glycol, sea whip extract, aminomethyl propanol water, ethyl macadamiate, propanediol, glycerin, butylene glycol, polyacrylamide, phenoxyethanol, C13-14 isoparaffin, bisabolol, laureth-7, allantoin, melaleuca alternifolia (tea tree) leaf oil, methylisothiazolinone, sodium hyaluronate, methyl methacrylate/glycol dimethacrylate crosspolymer, sodium hydroxide

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 eachPer 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acne Free SENSITIVE SKIN 24 HR Acne Clearing Systemthis 80861-0007-01 AcneFree 1 kit — — 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

🏛️
2017
On the market since
Dec 2017
📍
2026
Currently FDA-listed
9 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80861-0007-01 You're viewing this 1 KIT in 1 KIT (80861-007-01) * 118 mL in 1 BOTTLE (80861-008-01) * 59 mL in 1 BOTTLE (80861-009-01) 2017-12-01 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 80861-007-01, 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: 80861-0007-01, written without dashes as 80861000701. 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 80861-0007-01, the first segment (80861) is the labeler code FDA assigned to AcneFree LLC; the middle segment (0007) 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 AcneFree LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AcneFree 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.

📄 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 12 words ▾

Use for the treatment of acne

Use for the treatment of acne

⏱️ Dosage and Administration 140 words ▾

Directions • use every morning and evening • apply a dime-size amount to damp skin and gently massage, avoiding the eye area • rinse well • if bothersome dryness or peeling occurs, reduce application use • may be used on chest or back

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 • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

⚠️ Warnings 210 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.

Warnings For external use only Do not use if you • have very sensitive skin • are sensitive to benzoyl peroxide 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. • avoid unnecessary sun exposure and use a sunscreen • avoid contact with the eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling.

Irritation may be reduced by using the product less frequently or in a lower concentration. Stop use and ask a doctor if skin irritation becomes severe Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 16 words ▾

Active ingredient Salicylic acid 1.5% Purpose Acne treatment

Active ingredient Benzoyl peroxide 3% Purpose Acne treatment

🧪 Inactive Ingredients 73 words ▾

Inactive ingredients water, sodium cocoyl isethionate, stearic acid, cocamidopropyl betaine, sodium lauroamphoacetate, disodium laureth sulfosuccinate, glycol distearate, polyacrylate-1 crosspolymer, benzyl alcohol, avena sativa (oat) kernel extract, sodium phytate, zinc PCA, glycerin, sorbic acid, ethyl vanillin, butylene glycol, sea whip extract, aminomethyl propanol

Inactive ingredients water, ethyl macadamiate, propanediol, glycerin, butylene glycol, polyacrylamide, phenoxyethanol, C13-14 isoparaffin, bisabolol, laureth-7, allantoin, melaleuca alternifolia (tea tree) leaf oil, methylisothiazolinone, sodium hyaluronate, methyl methacrylate/glycol dimethacrylate crosspolymer, sodium hydroxide

🎯 Purpose 6 words ▾

Purpose Acne treatment

Purpose Acne treatment

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 80861-0006-01 · AcneFree, 80861-0010-01 · AcneFree, →
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.