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24 Hour Sensitive Skin Acne Clearing System Salicylic Acid Kit — NDC 80861-0118-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

24 Hour Sensitive Skin Acne Clearing System Salicylic Acid Kit — NDC 80861-118-01 (Billing 80861-0118-01)

by Acne Free LLC · 1 KIT in 1 KIT * 118 mL in 1 BOTTLE * 59 mL in 1 BOTTLE

This is a package of 24 Hour Sensitive Skin Acne Clearing System Salicylic Acid Kit from Acne Free LLC, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 80861-0118-01
🏷️ FDA NDC (as labeled) 80861-118-01 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 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 80861-118-01
Product NDC 80861-118
11-digit billing NDC 80861011801
RxCUI 422997, 1234456
Application # M006
SPL Set ID 39ea674d-ff6e-a8c6-e063-6394a90a0656
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-14
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 422997
Why two NDCs? The FDA registers this code as 80861-118-01 — 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 → 80861-0118-01. 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.

Clinical

🧪 What is this product?

This is an over-the-counter kit product containing salicylic acid, marketed under FDA's established guidelines for acne-clearing products. Salicylic acid is a beta hydroxy acid typically used in acne care to help exfoliate skin and unclog pores. This multi-step system is intended for daily use on sensitive skin types and comes as a complete kit with multiple components designed to work together as part of a skincare routine.

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.

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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
80861-0118-01 You're viewing this Main listing 1 KIT in 1 KIT * 118 mL in 1 BOTTLE * 59 mL in 1 BOTTLE 2025-07-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Salicylicum acidum 6 [hp_C]/6[hp_C] 00220-4526-41 Boiron 1 tube — — FDA listed —
Salicylicum acidum 30 [hp_C]/30[hp_C] 00220-4528-41 Boiron 1 tube — — FDA listed —
Acne Advanced Treatment System 15751-3000-03 Eminence 1 kit — — FDA listed —
Compound W Total Care Wart and Skin Kit 49354-0130-00 HK 1 kit — — FDA listed —
Dr. C. Tuna Acne Clear Complexion Cleanser 74690-0021-00 Farmasi 1 kit — — FDA listed —
Ambi Even and Clean Skin Tone Kit 73453-0110-01 Ambi 1 kit — — FDA listed —
Neutrogena Evenly Clear Acne Prone Skin Essentials 69968-1005-09 Kenvue 1 kit — — FDA listed —
Salicylicum Acidum 200 [kp_C]/200[kp_C] 00220-4512-41 Boiron 1 tube — — FDA listed —
24 Hour Sensitive Skin Acne Clearing Systemthis 80861-0118-01 Acne 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

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year 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.

From the label’s inactive-ingredient sectionwater, cocamidopropyl betaine, sodiumcocoyl isethionate, glycerin, coco-glucoside, acrylates/Cl 0-30 alkyl acrylate crosspolymer, sodium hydroxide, sodium benzoate, guar hydroxypropyltrimonium chloride, tocopheryl acetate, sodium hyaluronate, ascorbyl palmitate, citric acid, gluconolactone, chamomilla recutita (matricaria) flower extract, avena sativa (oat) bran extract, citrus aurantium dulcis (orange) peel extract water, Cl2-15 alkyl benzoate, glycerin, squalane, polyacrylamide, glyceryl stearate, PEG-100 stearate, cetyl alcohol, phenoxyethanol, cetearyl alcohol, Cl3-14 isoparaffin, arachidyl alcohol, pyrus malus (apple) fruit extract, behenyl alcohol, ceteareth-20, sodium hydroxide, laureth-7, arachidyl glucoside, polyglyceryl-3 cocoate, polyglyceryl-4 caprate, polyglyceryl-6 caprylate, polyglyceryl-6 ricinoleate, ethylhexylglycerin, 3-o-ethyl ascorbic acid, tocopheryl acetate, avena saliva (oat) kernel extract, sodium hyaluronate, chamomilla recutita (matricaria) flower extract

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.

Manufacturer & labeler

LabelerAcne Free LLC
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code80861
First marketedJul 2025
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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

Use for treatment of acne

Use for the treatment of acne

⏱️ Dosage and Administration 116 words ▾

Directions Use every morning and evening Apply a dime-size amount to damp skin and gently massage, avoiding eye area Rinse well Use wash on entire affected area one to two times daily May be used on chest or back

Directions • Cleanse thoroughly before applying treatment. • Apply a thin layer to the affected area one to three times daily. • Because excess drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor. • If bothersome dryness or peeling occurs, reduce to once a day or even every other day. • May be used on chest or back.

⚠️ Warnings 173 words ▾

Warnings For external use only When using this product Avoid contact with eyes 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 contact occurs, rinse thoroughly with water Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away When using this product skin initation and dryness is more likely to occur r you use another topical acne medic,rnon at the same time.

If irritation occurs, only use one topical acne medication at a time.

Warnings For external use only 1. When using this product 2. Avoid contact with eyes 1. skin initation and dryness is more likely to occur r you use another topical acne medic,rnon at the same time. If irritation occurs, only use one topical acne medication at a time. 2. If contact occurs, rinse thoroughly with water Stop use and ask a doctor if skin irritation occurs.

🧪 Active Ingredient 10 words ▾

Active Ingredient Salicylic acid 1.5%

Active ingredient Salicylic acid 1.5%

🧪 Inactive Ingredients 107 words ▾

Inactive ingredients water, cocamidopropyl betaine, sodiumcocoyl isethionate, glycerin, coco-glucoside, acrylates/Cl 0-30 alkyl acrylate crosspolymer, sodium hydroxide, sodium benzoate, guar hydroxypropyltrimonium chloride, tocopheryl acetate, sodium hyaluronate, ascorbyl palmitate, citric acid, gluconolactone, chamomilla recutita (matricaria) flower extract, avena sativa (oat) bran extract, citrus aurantium dulcis (orange) peel extract

Inactive ingredients water, Cl2-15 alkyl benzoate, glycerin, squalane, polyacrylamide, glyceryl stearate, PEG-100 stearate, cetyl alcohol, phenoxyethanol, cetearyl alcohol, Cl3-14 isoparaffin, arachidyl alcohol, pyrus malus (apple) fruit extract, behenyl alcohol, ceteareth-20, sodium hydroxide, laureth-7, arachidyl glucoside, polyglyceryl-3 cocoate, polyglyceryl-4 caprate, polyglyceryl-6 caprylate, polyglyceryl-6 ricinoleate, ethylhexylglycerin, 3-o-ethyl ascorbic acid, tocopheryl acetate, avena saliva (oat) kernel extract, sodium hyaluronate, chamomilla recutita (matricaria) flower extract

🎯 Purpose 6 words ▾

Purpose Acne treatment

Purpose Acne treatment

📄 When Using This Product 134 words ▾

When using this product Avoid contact with eyes 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 contact occurs, rinse thoroughly with water

When using this product skin initation and dryness is more likely to occur r you use another topical acne medic,rnon at the same time. If irritation occurs, only use one topical acne medication at a time.

1. When using this product 2. Avoid contact with eyes 1. skin initation and dryness is more likely to occur r you use another topical acne medic,rnon at the same time. If irritation occurs, only use one topical acne medication at a time. 2. If contact occurs, rinse thoroughly with water

📄 Stop Use and Ask a Doctor If 10 words ▾

Stop use and ask a doctor if skin irritation occurs.

📄 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

📄 Questions or Comments 8 words ▾

Questions or comments? 1-888-768-2913

Questions or comments? 1-888-768-2913

📄 Package Label / Principal Display Panel 13 words ▾

Kit 80861-118 Kit

Acne cleanser 80861-008

1.5 Cleanser

Acne lotion 80861-119 1.5 lotion

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 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 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 Acne Free LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Acne Free 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.
← 80861-0117-01 · Acne 80883-0097-00 · Miracle →
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.