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Clinicians Complex Sulfur 100 mg/g Lotion, 31 g — NDC 61352-0001-01 package photo

Clinicians Complex Sulfur 100 mg/g Lotion, 31 g

by Cosmed Dermaceuticals, Inc. · 31 g in 1 BOTTLE, GLASS (61352-001-01)
NDC 61352-0001-01
🏷️ FDA NDC (as labeled) 61352-001-01 billing pads the product segment with a zero
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) 61352-001-01
Product NDC 61352-001
11-digit billing NDC 61352000101
RxCUI 240725
UNII 70FD1KFU70
Application # M006
SPL Set ID 256e3e4e-2219-45f8-ab78-a6a541767de8
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2013-12-11
Route TOPICAL
Dosage form LOTION
Substance SULFUR
Why two NDCs? The FDA registers this code as 61352-001-01 — 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 → 61352-0001-01. 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 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

LabelerCosmed Dermaceuticals, Inc.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code61352
First marketedDec 2013
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.

🩺 Clinical

🧪 What is this product?

Clinicians Complex Sulfur 100 mg/g Lotion is an over-the-counter topical lotion containing sulfur. This product is marketed under FDA's OTC monograph rules for skin-care products. Sulfur is commonly used in topical products for its keratolytic and antimicrobial properties, and is typically applied to the skin to help address certain scalp and skin conditions. This lotion form allows for easy application to affected areas.

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 5TJD82A1ET
    A cooling crystalline substance made synthetically that is added to medicines as a fragrance, flavoring agent, and mild local irritant to produce a cooling or warming sensation on the skin or mucous membranes.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • UNII O414PZ4LPZ
    A beta hydroxy acid derived from willow bark or synthesized chemically. In topical medicines, it acts as a keratolytic agent that helps soften and shed dead skin cells, improving penetration of active ingredients.
  • 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 SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

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

The official label also statesIsopropyl Alcohol, Water, Zinc Oxide, Camphor, Magnesium Aluminum Silicate, Salicylic Acid, Iron Oxides.

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.
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
Thayers Natural Remedies Since 1847 Rapid Acne Treatment 100 mg/mL 49967-0415-01 L'Oreal 1 tube — — FDA listed —
Vichy Laboratoires Normaderm SOS Acne Rescue Spot Corrector 100 mg/mL 49967-0648-01 L'Oreal 1 tube — — FDA listed —
Kiehls Since 1851 Dermatologist Solutions Breakout Control Targeted Acne Spot Treatment 100 mg/mL 49967-0895-01 L'Oreal 1 tube — — FDA listed —
Clinicians Complex 100 mg/gthis 61352-0001-01 Cosmed 31 g — — FDA listed —
Neutrogena Stubborn Acne Spot Drying 100 mg/mL 69968-0761-01 Kenvue 1 bottle — — FDA listed —
Clinicians Complex 100 mg/g 72622-0001-01 SkinSx.com, 31 g — — FDA listed —
Renu Laboratories Acne Sulphur L 1.4 g/14g 76348-0450-02 Renu 56 g — — FDA listed —
Derma E Acne Clarifying Mask 100 mg/g 54108-3710-05 derma 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

🏛️
2013
On the market since
Dec 2013
📍
2026
Currently FDA-listed
13 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 Sulfur — the ingredient across all brands.

Top reported reactions

Dry Skin2,591
Acne2,277
Erythema2,238
Skin Burning Sensation2,035
Skin Irritation1,283
Skin Exfoliation1,181
Rash1,010

Reporter sex

15,367 reports

Serious outcomes

Hospitalization1,719
Life-threatening688
Disabling421
Death306
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,131 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
61352-0001-01 You're viewing this 31 g in 1 BOTTLE, GLASS (61352-001-01) 2018-02-13 Active

🧭 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 61352-001-01, 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: 61352-0001-01, written without dashes as 61352000101. 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 61352-0001-01, the first segment (61352) is the labeler code FDA assigned to Cosmed Dermaceuticals, Inc.; the middle segment (0001) 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 Cosmed Dermaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cosmed Dermaceuticals, 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 25 words ▾

Uses: For the treatment of acne • Dries up acne pimples • Dries and clears acne blemishes Helps keep skin clear of new acne blemishes

⏱️ Dosage and Administration 46 words ▾

Directions: ​DO NOT SHAKE SOLUTION ​ • Cleanse the skin thoroughly before applying medication • Dip clean cotton swab into sediment and apply directly to blemishes. Because excessive drying of the skin may occur, limit use to one application daily, or as directed by a physician.

⚠️ Warnings 103 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 • Do not use on broken skin or large areas of the skin • When using this product apply only to areas with acne. Avoid contact with eyes • If excessive irritation develops or increases, discontinue use and consult a doctor • Keep out of reach of children • If swallowed, get medical help or contact Poison Control Center right away.

🧪 Active Ingredient 4 words ▾

Active Ingredients: Sulfur 10%

🧪 Inactive Ingredients 15 words ▾

Inactive Ingredients: Isopropyl Alcohol, Water, Zinc Oxide, Camphor, Magnesium Aluminum Silicate, Salicylic Acid, Iron Oxides.

🎯 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 ↗
← 61333-0500-01 · Lights 61352-0004-01 · Cosmed →
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.