HomeNDC LookupIngredientsSodium Sulfacetamide › 83720-0543-16
Sodium Sulfacetamide 10% wash 100 mg/mL Liquid, 473 mL — NDC 83720-0543-16 package photo

Sodium Sulfacetamide 10% wash 100 mg/mL Liquid, 473 mL

by Oncor Pharmaceuticals · 473 mL in 1 BOTTLE (83720-543-16)
NDC 83720-0543-16
🏷️ FDA NDC (as labeled) 83720-543-16 billing pads the product segment with a zero
Rx only 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 →

🆔 Identity & classification

FDA NDC (as labeled) 83720-543-16
Product NDC 83720-543
11-digit billing NDC 83720054316
NCPDP billing unit ML — per mL (volume)
RxCUI 1006107
UNII 4NRT660KJQ
UPC 0383720543164
SPL Set ID 448e383a-2dbe-411f-a8a7-c83156e8a503
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
GCN Seq No 063084
GCN 98844
HICL code 003345
Ingredient (HICL) Sulfacetamide Sodium
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5E
Therapeutic class — specific (HIC3) Antiseborrheic Agents
AHFS code 84:04.92.00
AHFS class Local Anti-Infectives, Miscellaneous
FDB label name SODIUM SULFACETAMIDE 10% WASH
FDB brand name Sodium Sulfacetamide
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 83720-543-16 — 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 → 83720-0543-16. 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.

🏭 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.

🩺 Clinical

Label name SODIUM SULFACETAMIDE 10% WASH Ingredient Sulfacetamide Sodium
🧪 What is this product?

This is a topical liquid wash containing 10% sodium sulfacetamide, a sulfonamide antibiotic. Sulfacetamide sodium is typically used in skin cleansing products to help reduce bacteria on the skin surface. This product is an unapproved drug marketed without an approved FDA application. It is dispensed by prescription and applied directly to affected skin areas.

Supplement & herbal interactions

Some supplements/herbs that may interact with sodium sulfacetamide — tap one for details:

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 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 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 BPV390UAP0
    Sodium laureth sulfate is a mild detergent and surfactant derived from coconut oil or petroleum. It helps mix oil and water in formulations and is often used as a cleaning or foaming agent in topical products like shampoos and cleansers.
  • 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.

15 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 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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sodium Sulfacetamide 100 mg/g 58657-0477-06 Method 177 g $0.114 Availability likely
Sodium Sulfacetamide 100 mg/mL 42192-0129-16 Acella 480 ml $0.240 Availability likely
OVACE Plus 100 mg/mL 00178-0490-04 Mission 10 tubes FDA listed
Ovace 100 mg/mL 00178-0499-06 Mission 180 ml FDA listed
Ovace Plus 100 mg/mL 00178-0630-16 Mission 473 ml FDA listed
Sodium Sulfacetamide 100 mg/mL 16477-0410-06 Laser 177 ml FDA listed
Sulfacetamide Sodium 100 mg/mL 24470-0935-12 Cintex 355 ml FDA listed
Sulfacetamide Sodium 100 mg/mL 24470-0937-06 Cintex 177 ml FDA listed
Sulfacetamide Sodium 100 mg/mL 44523-0568-12 BioComp 355 ml FDA listed
Sodium Sulfacetamide 100 mg/mL 44523-0606-12 BioComp 355 ml FDA listed
Sodium Sulfacetamide 100 mg/mL 44523-0613-06 BioComp 177 ml FDA listed
Sodium Sulfacetamide 100 mg/g 63629-9262-01 Bryant 177 g FDA listed
Sodium Sulfacetamide 100 mg/g 63629-9263-01 Bryant 355 g FDA listed
Sodium Sulfacetamide 100 mg/g 63629-9264-01 Bryant 480 g FDA listed
Sodium Sulfacetamide 100 mg/mL 71399-0480-02 Akron 360 ml FDA listed
Sodium Sulfacetamide 100 mg/g 72162-1665-02 Bryant 355 g FDA listed
Sodium Sulfacetamide 10% wash 100 mg/mLthis 83720-0543-16 Oncor 473 ml 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.

🔬 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 — the ingredient across all brands.

Top reported reactions

Pain21
Nausea13
Condition Aggravated10
Erythema9
Fatigue9
Rash8
Somnolence8

Age at onset

Adolescent2
Adult39
Elderly8

Reporter sex

208 reports
Male · 38%
Female · 62%

Serious outcomes

Hospitalization25
Death2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 21 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
83720-0543-16 You're viewing this 473 mL in 1 BOTTLE (83720-543-16) 2025-11-14 Active

🧭 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 FDA registers it as 83720-543-16, 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: 83720-0543-16, written without dashes as 83720054316. 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 83720-0543-16, the first segment (83720) is the labeler code FDA assigned to Oncor Pharmaceuticals; the middle segment (0543) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) 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 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.

📄 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 39 words

INDICATIONS Sodium Sulfacetamide is intended for topical application in the following scaling dermatoses: Seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

⏱️ Dosage and Administration 168 words

DOSAGE AND ADMINISTRATION Seborrheic dermatitis including seborrhea sicca - Wash affected areas twice daily (morning and evening)or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin working into a full lather, rinse thoroughly, pat dry and repeat after 10 to 20 seconds.

Rinsing with plain water will remove any excess medication. Repeat application as described above for 8 to 10 days or as directed by your physician. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently.

Regular shampooing following the use of f this product is not necessary, but the hair should be shampooed at least once a week. As the condition subsides, the interval between applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence.

Should the condition recur after stopping therapy, the application of this product should be reinitiated as at the beginning of treatment.

Contraindications 32 words

CONTRAINDICATIONS This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

⚠️ Warnings and Cautions 70 words

WARNING FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN.

Avoid contact with eyes, lips and mucous membranes. Sulfonamides are known to cause sevens-johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topica ly.

Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome.

🤒 Adverse Reactions 52 words

ADVERSE REACTIONS Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported.

🔄 Drug Interactions 9 words

DRUG INTERACTIONS This product is incompatible with silver preparations.

🤰 Pregnancy 58 words

PREGNANCY Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only If clearly needed or when potential benefits outweigh potential hazards to the fetus.

🧒 Pediatric Use 17 words

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

🆘 Overdosage 65 words

OVERDOSAGE The oral LD50 of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately. Overdosage may cause nausea and vomiting. Large oral over dosage may cause hematuria, crystalluria and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract. For treatment, contact your local Poison Control Center or your doctor.

🧬 Clinical Pharmacology 118 words

CLINICAL PHARMACOLOGY Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive gram positive and gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There is no clinical data available on the degree and rate of systemic absorption of this product when applied to the skin or scalp.

However, significant absorption of sodium sulfacetamide through the skin has been reported. The fo lowing in vitro data is available but the clinical signicance is unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsie la pneumoniae, Pseudomonas pyocyanea, Salmone la species, Proteus vulgaris, Nocardia and Actinomyces.

📦 How Supplied / Storage and Handling 18 words

HOW SUPPLIED This product is supplied in the following size(s): 16 fl oz. (473 ml) bottles NDC 83720-543-16

📦 Storage and Handling 46 words

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

📋 Description 128 words

Rx Only For External Use Only Not For Ophthalmic Use. DESCRIPTION Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of: Butylated hydroxytoluene, Citric acid, Cetyl alcohol, Cocamidopropyl betaine, Disodium EDTA, Glycerin, Glyceryl stearate SE, PEG-100 stearate, Phenoxyethanol, Purified water, Sodium laureth sulfate, Sodium thiosulfate, Stearyl alcohol, Triacetin, Xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity.

Sodium sulfacetamide is C 8 H 9 N 2 NaO 3 S · H 2 O with molecular weight of 254.24. Chemically. sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl)-acetamide, monosodium salt, monohydrate. The structural formula is: Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste.

It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether. Structure

💬 Information for Patients 60 words

INFORMATION FOR PATIENTS Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. The use of this product also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop. Avoid contact with eyes, lips and mucous membranes.

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.