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Sodium Sulfacetamide 8% Sulfur 4% CLEANSER 80 mg/mL; 40 mg/mL Liquid, 473 mL — NDC 83720-0542-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Sodium Sulfacetamide 8% Sulfur 4% CLEANSER 80 mg/mL; 40 mg/mL Liquid, 473 mL — NDC 83720-542-16 (Billing 83720-0542-16)

by Oncor Pharmaceuticals · 473 mL in 1 BOTTLE, PLASTIC

This is a package of 473 mL of Sodium Sulfacetamide 8% Sulfur 4% CLEANSER 80 mg/mL; 40 mg/mL Liquid from Oncor Pharmaceuticals, marketed since Nov 2025 and currently FDA-listed. It is this product's only package size.

NDC 83720-0542-16
🏷️ FDA NDC (as labeled) 83720-542-16 billing pads the product segment with a zero
Rx only On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83720-542-16
Product NDC 83720-542
11-digit billing NDC 83720054216
NCPDP billing unit ML — per mL (volume)
RxCUI 1010234
UNII 4NRT660KJQ, 70FD1KFU70
UPC 0383720542105, 0383720542167
SPL Set ID d44a7a26-ea6b-469f-931a-812a031868ea
Established class (EPC) Sulfonamide Antibacterial
Chemical class Sulfonamides
DEA schedule Non-controlled
Marketing category UNAPPROVED DRUG OTHER
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-14
Route TOPICAL
Dosage form LIQUID
Substance SULFACETAMIDE SODIUM; SULFUR

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 066791
GCN 29180
HICL code 003344
Ingredient (HICL) Sulfacetamide Sodium/Sulfur
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5S
Therapeutic class — specific (HIC3) Topical Sulfonamides
AHFS code 84:04.92.00
AHFS class Local Anti-Infectives, Miscellaneous
FDB label name SULFACETAMIDE-SULFUR 8-4% SUSP
FDB brand name Sodium Sulfacetamide-Sulfur
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066791
  • GCN: 29180
  • HICL (First Databank): 003344
  • AHFS class code: 84:04.92.00
  • RxCUI (RxNorm): 1010234
Why two NDCs? The FDA registers this code as 83720-542-16 — 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 → 83720-0542-16. 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 Sulfonamide Antibacterial class.

Pharmacologic class Sulfonamide Antibacterial
Drug family (ATC) Antiinfectives for treatment of acne, Sulfonamides
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

Label name SULFACETAMIDE-SULFUR 8-4% SUSP Ingredient Sulfacetamide Sodium/Sulfur
🧪 What is this product?

This is a prescription topical liquid cleanser containing sulfacetamide sodium and sulfur. Sulfacetamide sodium is an antibiotic commonly used in skin care products to help reduce bacteria, while sulfur is typically used for its keratolytic and antimicrobial properties in treating skin conditions. The combination is generally intended for cleansing affected skin areas as part of a treatment regimen. This product is marketed without an approved FDA 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.

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 mLPer 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
83720-0542-16 You're viewing this Main listing 473 mL in 1 BOTTLE, PLASTIC 2025-11-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Sulfacetamide and Sulfur 80 mg/mL; 40 mg/mL 42192-0133-16 Acella 473 ml $0.071 — Availability likely —
Sodium Sulfacetamide 8% and Sulfur 4% Cleanser 80 mg/mL; 40 mg/mL 58657-0469-16 Method 473 ml $0.071 — Availability likely —
Sodium Sulfacetamide and Sulfur 80 mg/mL; 40 mg/mL 69367-0245-16 Westminster 473 ml $0.071 — Availability likely —
Sodium Sulfacetamide, Sulfur 40 mg/mL; 80 mg/mL 24470-0951-16 Cintex 473 ml — — FDA listed —
Sodium Sulfacetamide And Sulfur 80 mg/mL; 40 mg/mL 44523-0624-16 BioComp 473 ml — — FDA listed —
Sodium Sulfacetamide, Sulfur 40 mg/mL; 80 mg/mL 52187-0531-16 KMM 473 ml — — FDA listed —
Sodium Sulfacetamide 8% and Sulfur 4% 80 mg/mL; 40 mg/mL 71399-0487-06 Akron 473 ml — — FDA listed —
Sodium Sulfacetamide 8% and Sulfur 4% Cleanser 80 mg/mL; 40 mg/mL 72162-2247-02 Bryant 473 ml — — FDA listed —
Sodium Sulfacetamide 8% Sulfur 4% CLEANSER 80 mg/mL; 40 mg/mLthis 83720-0542-16 Oncor 473 ml — — FDA listed —
Sodium Sulfacetamide, Sulfur 80 mg/g; 40 mg/g 87026-0203-16 Aspen 473 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

🏛️
2025
On the market since
Nov 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • UNII W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII HX1032V43M
    Sodium thiosulfate is a salt compound used in medicines as a buffer and pH regulator. It helps stabilize the medication and may also serve as a preservative or antioxidant to maintain product quality.
  • 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 XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
  • 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.

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

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.

Manufacturer & labeler

LabelerOncor Pharmaceuticals
Labeler code83720
First marketedNov 2025
Product typeHuman Prescription Drug
Portfolio9 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 23 words ▾

INDICATIONS Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

⏱️ Dosage and Administration 75 words ▾

DOSAGE AND ADMINISTRATION Apply Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension once or twice daily to affected areas, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10-20 seconds, working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension sooner or using less often.

⛔ Contraindications 36 words ▾

CONTRAINDICATIONS This product is contraindicated for use by persons with known or suspected hypersensitivity to sulfonamides, sulfur or any other component of this preparation. This product is not to be used by patients with kidney disease.

⚠️ Warnings 67 words ▾

WARNINGS Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides.

Particular caution should be employed if areas of denuded or abraded skin are involved.

🤒 Adverse Reactions 19 words ▾

ADVERSE REACTIONS Although rare, sodium sulfacetamide may cause local irritation. Call your doctor for medical advice about side effects.

🤰 Pregnancy 66 words ▾

PREGNANCY Category C Animal reproduction studies have not been conducted with Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension. It is not known whether Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 16 words ▾

PEDIATRIC USE Safety and effectiveness in children under the age of 12 have not been established.

🧬 Clinical Pharmacology 113 words ▾

CLINICAL PHARMACOLOGY The most widely accepted mechanism of action of sulfonamides is the woods fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours.

The exact mode of action of sulfur in the treatment of acne is not known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

📦 How Supplied / Storage and Handling 21 words ▾

HOW SUPPLIED Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension is available in 10 fl oz (296 mL) bottles NDC 83720-542-10.

📦 Storage and Handling 74 words ▾

STORAGE Store at 20 o C to 25 o C ( 68 o F to 77 o F ), excursions permitted between 15 o C and 30 o C (between 59 o F and 86 o F ). Brief exposure to temperatures up to 40°C (104 o F) may be tolerated provided the mean kinetic temperature does not exceed 25 o C (77 o F) however, such exposure should be minimized. Protect from freezing.

📋 Description 93 words ▾

DESCRIPTION Each gram of Sodium Sulfacetamide 8% and Sulfur 4% Topical Suspension contains 80 mg of sodium sulfacetamide and 40 mg of sulfur in a formulation containing Aloe vera leaf extract, Butylated hydroxytoluene, Cetyl alcohol, Citric acid, Cocamidopropyl betaine, Disodium EDTA, Glycerin, Glyceryl stearate SE, Green tea extract, PEG-100 stearate, Phenoxyethanol, Purified water, Sodium laureth sulfate, Sodium thiosulfate, Stearyl alcohol, Triacetin, Xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent.

Chemica ly sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: structure

💬 Information for Patients 29 words ▾

INFORMATION FOR PATIENTS Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.

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

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 Sodium Sulfacetamide and Sulfur — the ingredient across all brands.

Top reported reactions

Asthma2
Erythema2
Hypersensitivity2
Impaired Quality Of Life2
Injection Site Pruritus2
Injection Site Swelling2
Lethargy2

Age at onset

Adolescent1
Adult4
Elderly2

Reporter sex

0 reports

Serious outcomes

Hospitalization3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5 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.

About this NDC listing & data coverage

Finished prescription product Marketed without an FDA application

Listed without an FDA application

This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.

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 "Unapproved Drug Other". 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 Oncor Pharmaceuticals. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Oncor Pharmaceuticals 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 83720-0523-01 · Oncor 83720-0543-16 · Oncor →
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.