HomeNDC LookupIngredientsSulfur › 26050-0101-02
Anti Acne Natural Volcanic Sulfur 10 g/100g Soap, 20 g — NDC 26050-0101-02 package photo

Anti Acne Natural Volcanic Sulfur 10 g/100g Soap, 20 g

by PT. GALENIUM PHARMASIA LABORATORIES · 20 g in 1 BOX (26050-101-02)
NDC 26050-0101-02
🏷️ FDA NDC (as labeled) 26050-101-02 billing pads the product segment with a zero
This package
Contains20 g Pack sizes2 compare ↓
Also comes in: 100 g 26050-0101-01
OTC On market Non-controlled
🗂️ Data synced Sep 18, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 26050-101-02
Product NDC 26050-101
11-digit billing NDC 26050010102
RxCUI 1053330
UNII 70FD1KFU70
Application # M006
SPL Set ID a19ac01b-950a-4ddb-9711-17f15bdb4013
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-10-01
Route TOPICAL
Dosage form SOAP
Substance SULFUR
Why two NDCs? The FDA registers this code as 26050-101-02 — 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 → 26050-0101-02. 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

LabelerPT. GALENIUM PHARMASIA LABORATORIES
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code26050
First marketedOct 2012
Product typeHuman Otc Drug
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 soap containing 10 percent sulfur, marketed as an over-the-counter monograph drug under FDA rules for acne care products. Sulfur is commonly used in acne and skin care preparations for its keratolytic and antimicrobial properties. The soap form allows the sulfur to be applied directly to the skin during cleansing. This product is intended for topical use on the skin.

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 92005F972D
    A foaming and thickening agent derived from coconut oil. It's used in liquid medicines to improve texture, help distribute active ingredients evenly, and create a pleasant consistency for easier swallowing or application.
  • 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 7EV65EAW6H
    Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
  • UNII B0S90M0233
    Palm kernel oil is a natural fat extracted from palm seeds. It's used in medicines as a lubricant and binder to help tablets hold together and flow 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 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.

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

The official label also statesSaponified Palm and Palm Kernel Oil, Lanolin, Fragrance, Coconut Fatty Acid Diethanol Amide, Salicylic Acid 0.25%, Glycerin, Titanium Dioxide.

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 DailyMedingredient 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 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.
Try another pack size: 100 g
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
Earths Care Acne Spot Treatment 10 g/100g 24286-1557-01 DLC 1 tube FDA listed
Anti Acne Natural Volcanic Sulfur 10 g/100gthis 26050-0101-02 PT. 20 g FDA listed
Vivant Sulfur Clay Mask 10 g/100mL 63750-0006-04 Vivant 118 ml FDA listed
Sulfur Calming Mask 10 g/100g 70764-0103-52 CONTROL 1 jar FDA listed
Detoxify Facial Mask 10 g/100g 72957-0007-01 Private 85 g FDA listed
Sunday Riley Saturn Sulfur Acne Spot Treatment Mask .1 g/mL 73001-0305-15 Sunday 1 tube FDA listed
RoyceDerm Sulfur Soap. 23.2 g/232g 85424-0003-01 RoyceDerm 232 g FDA listed
Acne Treatment with Sulfur 10 g/100g 24286-1574-01 DLC 74 g FDA listed
Dermaharmony 10% Sulfur 10 g/100g 71819-0014-04 D3 113 g FDA listed
Dermaharmony 10% Sulfur with Tea Tree Oil 10 g/100g 71819-0015-04 D3 113 g 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

🏛️
2012
On the market since
Oct 2012
📍
2026
Currently FDA-listed
14 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

0 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 2,131 399
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
26050-0101-01 100 g in 1 BOX (26050-101-01) 2012-10-01 Active
26050-0101-02 You're viewing this 20 g in 1 BOX (26050-101-02) 2012-10-01 Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 26050-0101-02?
NDC 26050-0101-02 contains 20 g — 20 g in 1 box.
What is the difference between NDC 26050-0101-02 and NDC 26050-0101-01?
Both are Anti Acne Natural Volcanic Sulfur 10 g/100g Soap — the drug itself is identical. NDC 26050-0101-02 is the 20 g package, while NDC 26050-0101-01 is the 100 g package.
What NDC number is used to bill for this package of Anti Acne Natural Volcanic Sulfur 10 g/100g Soap?
Bill NDC 26050-0101-02 — the 11-digit billing format is 26050010102. 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 26050-101-02, 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: 26050-0101-02, written without dashes as 26050010102. 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 26050-0101-02, the first segment (26050) is the labeler code FDA assigned to PT. GALENIUM PHARMASIA LABORATORIES; the middle segment (0101) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 PT. GALENIUM PHARMASIA LABORATORIES. 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 100 g (26050-0101-01). 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?
PT. GALENIUM PHARMASIA LABORATORIES 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 6 words

Use for the treatment of acne.

⏱️ Dosage and Administration 64 words

Directions Work up a lather using warm water and apply to affected area. Rinse thoroughly and pat dry. 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 98 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.

Do not use on broken skin. Do not use on large areas of skin. Do not get into eyes.

If excessive skin Irritation develops or increases, discontinue use and consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

🧪 Active Ingredient 5 words

Active Ingredients Precipitated Sulfur 10%

🧪 Inactive Ingredients 21 words

Inactive ingredients Saponified Palm and Palm Kernel Oil, Lanolin, Fragrance, Coconut Fatty Acid Diethanol Amide, Salicylic Acid 0.25%, Glycerin, Titanium Dioxide.

🎯 Purpose 3 words

Purpose Acne medication

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.