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Proactiv Clean Mineral Acne Cleanser SULFUR 3 g/100mL Cream — NDC 11410-0457-05 package photo

Proactiv Clean Mineral Acne Cleanser SULFUR 3 g/100mL Cream

by Alchemee, LLC · 1 TUBE in 1 BOX (11410-457-05) / 60 mL in 1 TUBE
NDC 11410-0457-05
🏷️ FDA NDC (as labeled) 11410-457-05 billing pads the product segment with a zero
This package
Contains60 mL in 1 tube Pack sizes4 compare ↓
Also comes in: 10 mL 11410-0457-00 177.4 mL 11410-0457-10 60 ml 11410-0457-15
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 →

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) 11410-457-05
Product NDC 11410-457
11-digit billing NDC 11410045705
RxCUI 1046894
UNII 70FD1KFU70
UPC 0842944106239
Application # M006
SPL Set ID 380d0f8f-8d31-41b9-9d5f-8a35f7f81b5b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-08-15
Route TOPICAL
Dosage form CREAM
Substance SULFUR
Why two NDCs? The FDA registers this code as 11410-457-05 — 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 → 11410-0457-05. 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 Preparations containing sulfur class.

Drug family (ATC) Preparations containing sulfur
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

LabelerAlchemee, LLC
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code11410
First marketedAug 2022
Product typeHuman Otc Drug
Portfolio26 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 is this product?

This is a topical cream cleanser containing 3% sulfur, marketed as an over-the-counter monograph product for acne care. Sulfur is commonly used in acne products as a keratolytic agent, meaning it helps soften and shed dead skin cells from the surface. It is typically applied to the skin as part of a cleansing routine. This product is sold under FDA's established rules for over-the-counter acne cleansers rather than as an individually reviewed drug application.

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 1QR1QRA9BU
    A fatty alcohol derived from peanut oil or made synthetically. It serves as an emollient and thickener in creams and ointments, helping create smooth texture and improve product consistency.
  • UNII ICS790225B
    A plant-derived cleaning agent made from coconut oil and glucose. It works as a surfactant and emulsifier to help mix oil and water-based ingredients together in the formulation.
  • UNII 40U37V505D
    A fatty acid derived from coconut oil. It acts as an emulsifier to help mix water and oil-based ingredients, and may also serve as a surfactant or lubricant in tablet and capsule formulations.
  • UNII 13F4MW8Y9K
    Coconut alcohol is a natural alcohol derived from coconut oil. It's used in medicines as a solvent to dissolve other ingredients and help distribute them evenly throughout the product.
  • UNII 9G1OE216XY
    Docosanol is a waxy, fatty alcohol derived from plant sources. It acts as an emollient and thickener in topical medicines, helping to soften the skin and improve product texture and stability.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII SA5E43C17C
    Glycereth-18 is a synthetic liquid made from glycerin and ethylene oxide. It works as a humectant and solvent to help keep medicines moist and dissolve ingredients evenly throughout the product.
  • UNII IWS58C6V2Y
    A synthetic emollient and emulsifier derived from glycerin and fatty acids. It helps blend oil and water components in formulations and provides a smooth texture to creams, lotions, and other topical products.
  • 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 G0R4UBI2ZZ
    Matricaria chamomilla, commonly known as chamomile, is a plant extract used in medicines as a flavoring agent and natural fragrance component. It may also provide mild soothing properties to the formulation.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 518XTE8493
    A gentle cleanser derived from coconut oil, sodium cocoyl isethionate serves as a surfactant and foaming agent in topical products. It helps the medicine spread evenly on skin and creates lather.
  • 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 3R36J71C17
    A salt compound derived from isethionic acid, used as a buffering agent and pH stabilizer in medications to maintain proper acidity levels and improve product stability.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 5EHL50I4MY
    A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also stateswater, sodium cocoyl isethionate, coco-glucoside, acrylates copolymer, coconut acid, coconut alcohol, glycereth-18 ethylhexanoate, glycereth-18, behenyl alcohol, titanium dioxide (CI 77891), phenoxyethanol, sodium isethionate, sodium hydroxide, arachidyl alcohol, stearyl alcohol, xanthan gum, ethylhexylglycerin, glycerin, tetrasodium glutamate diacetate, chamomilla recumta (matricaria) flower extract

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 systemPer gPer 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: 10 mL 177.4 mL 60 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Proactiv Clean Mineral Acne Cleanser 3 g/100mLthis 11410-0457-05 Alchemee, 1 tube — — FDA listed —
EradiKate Daily Foaming Cleanser Acne Treatment 3 g/100mL 43479-0110-11 Kate 30 ml — — FDA listed —
Sulfur 3 mg/100mg 67923-0106-05 Vege 1 tube — — FDA listed —
PowerSpot Cleanse 30 mg/mL 72203-0014-01 Bluemercury 1 tube — — FDA listed —
EradiKate Daily Foaming Cleanser Acne Treatment 3 g/100mL 72204-0902-02 Rare 1 tube — — 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
Aug 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.

🔬 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 Proactiv Clean Mineral Acne Cleanser (this brand).

Top reported reactions

Drug Hypersensitivity162
Pain22
Dizziness20
Headache19
Malaise19
Fatigue18
Abdominal Distension16

Reporter sex

353 reports

Serious outcomes

Disabling12
Death6
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 31 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
11410-0457-00 1 TUBE in 1 BOX (11410-457-00) / 10 mL in 1 TUBE 2022-12-01 Active
11410-0457-05 You're viewing this 1 TUBE in 1 BOX (11410-457-05) / 60 mL in 1 TUBE 2022-08-15 Active
11410-0457-10 1 TUBE in 1 BOX (11410-457-10) / 177.4 mL in 1 TUBE 2022-08-15 Active
11410-0457-15 60 mL in 1 TUBE (11410-457-15) 2023-01-24 Active

Pack size FAQ

What quantity is in NDC 11410-0457-05?
NDC 11410-0457-05 is listed by the FDA — 1 tube in 1 box / 60 ml in 1 tube.
What NDC number is used to bill for this package of Proactiv Clean Mineral Acne Cleanser SULFUR 3 g/100mL Cream?
Bill NDC 11410-0457-05 — the 11-digit billing format is 11410045705. 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 11410-457-05, 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: 11410-0457-05, written without dashes as 11410045705. 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 11410-0457-05, the first segment (11410) is the labeler code FDA assigned to Alchemee, LLC; the middle segment (0457) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 Alchemee, LLC. 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 tube (11410-0457-00), 1 tube (11410-0457-10), 60 ml (11410-0457-15). 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?
Alchemee, 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 6 words ▾

Use for the management of acne

⏱️ Dosage and Administration 94 words ▾

Directions 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, follows the directions stated below. cover the entire affected area with a thin layer and rinse thoroughly 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 89 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. apply only to areas with acne. avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Do not use on broken skin large areas of the skin. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 4 words ▾

Active ingredient Sulfur 3%

🧪 Inactive Ingredients 43 words ▾

Inactive ingredients water, sodium cocoyl isethionate, coco-glucoside, acrylates copolymer, coconut acid, coconut alcohol, glycereth-18 ethylhexanoate, glycereth-18, behenyl alcohol, titanium dioxide (CI 77891), phenoxyethanol, sodium isethionate, sodium hydroxide, arachidyl alcohol, stearyl alcohol, xanthan gum, ethylhexylglycerin, glycerin, tetrasodium glutamate diacetate, chamomilla recumta (matricaria) flower extract

🎯 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 ↗
← 11410-0229-01 · Alchemee, 11410-0458-00 · Alchemee, →
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.