SODIUM SULFACETAMIDE 100 mg/mL Liquid, 480 mL
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Sulfonamide Antibacterial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
This is a liquid topical product containing sodium sulfacetamide, a sulfonamide antibiotic. Sulfacetamide is typically used in skin preparations to help control bacterial infections and is commonly found in products for acne and other skin conditions. This product is marketed as an unapproved drug and has not received an approved FDA application.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with sodium sulfacetamide — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 U72Q2I8C85
A mixture of fats derived from coconut oil that acts as an emulsifier and solubilizer. It helps blend oil and water-based ingredients together and improves how the body absorbs certain drugs.
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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.
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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.
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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 A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII 4Y0E651N0F
A plant-derived emulsifier made from almond oil and polyethylene glycol. It helps mix oil and water-based ingredients together and improves how the medicine dissolves and is absorbed in the body.
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UNII W9Q3DZS0EG
A waxy substance derived from plant or animal sources, used as a coating agent and binder in tablets and capsules to control how quickly the medicine dissolves and is absorbed in the body.
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UNII CAL22UVI4M
A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
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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.
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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 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.
11 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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.240 | $115.15 / 480 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.2720 | $130.56 / 480 ml |
| 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?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sodium Sulfacetamide 100 mg/g 58657-0477-06 | Method | 177 g | $0.114 | — | Availability likely | save 53% |
| Sodium Sulfacetamide 100 mg/mLthis 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/mL 83720-0543-16 | Oncor | 473 ml | — | — | FDA listed | — |
Where does this data come from?
⏳ 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?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 42192-0129-16 You're viewing this | 480 mL in 1 BOTTLE (42192-129-16) | 2011-01-04 | Active |
🧭 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) | ✓ Available |
| 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) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS: Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It is also indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.
⏱️ Dosage and Administration ▾
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 and pat dry.
Rinsing with plain water will remove any excess medication. Repeat application as described for eight to ten days. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently.
Regular shampooing following Sodium Sulfacetamide 10% Wash 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 Sodium Sulfacetamide 10% Wash should be reinstated as at the beginning of treatment. Secondary Cutaneuos Bacterial Infections - Wet skin and liberally apply to areas to be cleansed, massage gently into skin working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication.
Repeat application as described for eight to ten days. if skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less often.
⛔ Contraindications ▾
CONTRAINDICATIONS: Sodium Sulfacetamide 10% Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this product.
⚠️ Warnings ▾
WARNINGS: Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitivie 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 .)
🔄 Drug Interactions ▾
Drug Interactions: Sodium Sulfacetamide 10% Wash is incompatible with silver preparations.
🤰 Pregnancy ▾
PREGNANCY: Category C. Animal reproduction studies have not been conducted with Sodium Sulfacetamide 10% Wash. It is not known whether Sodium Sulfacetamide 10% Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% Wash should be given to a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
🧒 Pediatric Use ▾
PEDIATRIC USE: Safety and effectiveness in children under the age of 12 have not been established.
🆘 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.
🧬 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 Sodium Sulfacetamide 10% Wash 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 not known. Organisms which show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumonia, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces .
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Sodium Sulfacetamide 10% Wash is available in 16 fluid ounce bottles, NDC 42192-129-16.
📦 Storage and Handling ▾
Store at 20° - 25°C (68° - 77°F), excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature]. Do not freeze. Note: Store upright.
Protect from freezing and excessive heat. The wash may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product.
Occasionally, a slight yellowish discoloration may occur when an excessive amount of the wash 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. All prescription substitutions using this product shall be made subject to state and federal statutes as applicable.
NOTE: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency . Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.
📋 Description ▾
DESCRIPTION: Sodium sulfacetamide is C 8 H 9 N 2 NaO 3 S·H 2 O with molecular weight of 254.24. Chemically, it is Acetamide N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Each mL of Sodium Sulfacetamide 10% Wash contains 100 mg of sodium sulfacetamide, USP in a formulation containing cocamidopropyl betaine, disodium EDTA, glyceryl stearate, methylparaben, PEG-6 caprylic/capric glyerides, PEG-60 almond triglyceride, PEG-150 pentaerythrityl tetrastearate, polysorbate 60, purified water, sodium lauryl sulfate and sodium thiosulfate.
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 ▾
Information for patients - Patients should discontinue use of Sodium Sulfacetamide 10% Wash if the condition worsens, or is a rash develops in the area being treated or elsewhere. Sodium Sulfacetamide 10% Wash also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop.