Sodium Sulfacetamide and Sulfur 98 mg/g; 48 mg/g Lotion — NDC 44523-600-02 (Billing 44523-0600-02)
This is a package of Sodium Sulfacetamide and Sulfur 98 mg/g; 48 mg/g Lotion from BioComp Pharma, Inc., marketed since Jan 2025 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 44523-600-02 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 44523 labeler · 600 product · 02 package
- Package marketed since
- Jan 23, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0344523600027
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 072171
- GCN: 36291
- GPI-14 (Medi-Span): 90059903204109
- HICL (First Databank): 003344
- AHFS class code: 84:04.92.00
- RxCUI (RxNorm): 1494174
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Sulfonamide Antibacterial class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
This is a topical lotion containing sodium sulfacetamide and sulfur. Sodium sulfacetamide is a sulfonamide antimicrobial commonly used in skin care products for acne and bacterial skin conditions. Sulfur is typically used as a keratolytic agent in dermatology formulations to help remove dead skin and manage certain skin conditions. Together, these ingredients are often combined in topical preparations intended for cleansing and treating affected skin areas.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per g | Per 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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 44523-0600-02 You're viewing this Main listing | 1 BOTTLE, PLASTIC in 1 CARTON / 57 g in 1 BOTTLE, PLASTIC | 2025-01-23 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Plexion 48 mg/g; 98 mg/g 24470-0944-02 | Cintex | 57 g | — | — | FDA listed | — |
| Sulfacetamide Sodium, Sulfur 98 mg/g; 48 mg/g 24470-0957-02 | Cintex | 57 g | — | — | FDA listed | — |
| Plexion 48 mg/g; 98 mg/g 44118-0703-02 | Eckson | 57 g | — | — | FDA listed | — |
| Sodium Sulfacetamide And Sulfur 98 mg/g; 48 mg/gthis 44523-0600-02 | BioComp | 1 bottle | — | — | FDA listed | — |
| Sulfacetamide Sodium, Sulfur 98 mg/g; 48 mg/g 52187-0548-02 | KMM | 57 g | — | — | FDA listed | — |
| Sulfacetamide Sodium, Sulfur 98 mg/g; 48 mg/g 52187-0547-02 | KMM | 57 g | — | — | FDA listed | — |
| Sulfacetamide Sodium, Sulfur 98 mg/g; 48 mg/g 24470-0956-02 | Cintex | 57 g | — | — | FDA listed | — |
| Plexion 98 mg/g; 48 mg/g 57883-0404-10 | Brava | 10 packets | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
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.
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UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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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.
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UNII MP1J8420LU
A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
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UNII 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
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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.
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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.
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UNII 6F36Q0I0AC
PEG-150 distearate is a waxy substance made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and surfactant to help blend water and oil-based ingredients, and may also function as a thickener or lubricant in the formulation.
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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.
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UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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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.
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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.
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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.
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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.
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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.
14 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from BioComp Pharma, Inc. labeler code 44523
- Sodium Sulfacetamide 100 mg/mL Shampoo NDC 44523-510-08
- Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g Cream NDC 44523-520-02
- Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g Cream NDC 44523-542-02
- Sodium Sulfacetamide, Sulfur 100 mg/g; 20 mg/g Emulsion NDC 44523-550-08
- Sulfacetamide Sodium, Sulfur 100 mg/g; 50 mg/g Emulsion NDC 44523-560-06
- SULFACETAMIDE SODIUM 100 mg/mL Liquid NDC 44523-568-12
- Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g Lotion NDC 44523-602-01
- Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g Cream NDC 44523-603-01
- Sodium Sulfacetamide, Sulfur 100 mg/g; 50 mg/g Suspension NDC 44523-604-01
- Sodium Sulfacetamide and Sulfur 45 mg/g; 90 mg/g Lotion NDC 44523-605-16
- SODIUM SULFACETAMIDE 100 mg/mL Liquid NDC 44523-606-12
- Sodium Sulfacetamide and Sulfur 100 mg/g; 50 mg/g Lotion NDC 44523-607-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS: This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Cleanse affected areas. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily or as directed by a physician.
⛔ Contraindications ▾
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 ▾
WARNINGS: Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF THE REACH OF CHILDREN.
🤒 Adverse Reactions ▾
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 (see WARNINGS).
🆘 Overdosage ▾
OVERDOSAGE: The oral LD 50 of sulfacetamide in mice is 16.5 g/kg. In the event of overdosage, emergency treatment should be started immediately. Manifestations: Overdosage may cause nausea and vomiting. Large oral overdosage 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 ▾
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 following in vitro data is available but the clinical significance is unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.
The exact mode of action of sulfur in the treatment of acne is unknown, 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 ▾
HOW SUPPLIED: This product is supplied in the following size(s): 2 oz. (57 g) bottles, NDC 44523-600-02 To report a serious adverse event or obtain product information, call 1-866-762-2365. Manufactured for: BIOCOMP PHARMA ® , INC. San Antonio, TX 78230 1355 13571R0224 BCP_T13601R0324
📦 Storage and Handling ▾
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. NOTICE: Protect from freezing and excessive heat.
The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Keep dispensing container tightly closed.
Occasionally, a slight discoloration of fabric may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches.
📋 Description ▾
DESCRIPTION: Each gram contains 98 mg of sodium sulfacetamide and 48 mg of colloidal sulfur in a vehicle consisting of: benzyl alcohol, cetyl alcohol, disodium EDTA, fragrance, glyceryl stearate (and) PEG-100 stearate, magnesium aluminum silicate, PEG-150 distearate, phenoxyethanol, polyethylene glycol 400, purified water, sodium lauryl sulfate, sodium thiosulfate, stearyl alcohol and xanthan gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. 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. image
⚠️ Precautions ▾
PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. General: Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation.
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. If the use of this product produces signs of hypersensitivity or other untoward reactions, discontinue use of the preparation.
Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. 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.
Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis.
These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. 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 should also 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. Drug Interactions: This product is incompatible with silver preparations. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date.
Studies on reproduction and fertility also have not been performed. Chromosomal nondisjunction has been reported in the yeast, Saccharomyces cerevisiae, following application of sodium sulfacetamide. The significance of this finding to the topical use of sodium sulfacetamide in the human is unknown.
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. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in children under the age of 12 years have not been established.
📄 Package Label / Principal Display Panel ▾
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Medicare Part D spend CMS · PART D · 2026 (Q1)
Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
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. |