Prescription medicine
Sulfacetamide Brand names: Klaron; first approved as Sodium Sulamyd
Sulfacetamide (Klaron) is a prescription medicine with an FDA approval on record since 1946. FDA's NDC Directory lists it from 7 generic labelers, and pharmacies paid $0.110 per gram (Sodium sulfacetamide 10% wash) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the sulfacetamide FDA label on DailyMed (effective August 31, 2023, Bausch & Lomb Incorporated); the NDA 5963 record on Drugs@FDA; every sulfacetamide label on DailyMed.
Highlights of the record
FDA label of August 31, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageSulfacetamide sodium ophthalmic solution USP, 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.
Forms and strengths
- 100 mg/ml
Solution/ drops; lotion; solution.
On the market
- Earliest approval on file
- July 21, 1946 Sodium Sulamyd, Schering; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 22 first September 29, 1970; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 7 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.110 per gram Sodium sulfacetamide 10% wash
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2016 0 Class I among all firms' recalls; latest May 17, 2016
- FAERS reports
- 616 through July 30, 2026
What is sulfacetamide used for?
From the label: indications and usageSulfacetamide sodium ophthalmic solution USP, 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species. Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
Conditions named in the indications of sulfacetamide's FDA labels, with every medicine labeled for each:
From other sulfacetamide labelsBacterial infections: INDICATIONS AND USAGE Sulfacetamide sodium ophthalmic solution USP, 10% is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic …
Acne: INDICATIONS Sodium Sulfacetamide Lotion is indicated in the topical treatment of acne vulgaris.
FDA pharmacologic class: Sulfonamide Antibacterial.
Source: FDA drug label (Sulfacetamide Sodium), Bausch & Lomb Incorporated, effective August 31, 2023 (SPL set 6c1b2658-e756-4f31-9bc8-f99a0baa4637), via openFDA; the full label on DailyMed
Is there a generic for sulfacetamide (Klaron)?
The FDA approved the first generic sulfacetamide on September 29, 1970. 22 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sulfacetamide from 7 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1946 earliest approval on file
- 1970 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sulfacetamide (Klaron)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.110 per gram (Sodium sulfacetamide 10% wash), down 9% from $0.121 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Sodium sulfacetamide 10% wash (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sodium sulfacetamide 10% wash | Generic | $0.110 per gram | n/a | -9% |
| Sulfacetamide 10% eye drops | Generic | $1.96 per mL | n/a | -7% |
| Sulfacetamide sod 10% top suspension | Generic | $0.515 per mL | n/a | -16% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has sulfacetamide been recalled?
The FDA's Enforcement Report lists 1 recall naming sulfacetamide since 2016: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 17, 2016 | Class II | Akorn, Inc. | Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for sulfacetamide?
The FDA Adverse Event Reporting System holds 616 reports that list sulfacetamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 95 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as sulfacetamide?
8 other medicines are given the same way (ophthalmic) and in the same FDA class as sulfacetamide or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (ophthalmic) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ofloxacin | Bacterial infections | 23 labelers | $1.24 per mL 0.3% eye drops | No current entry |
| Tobramycin | Bacterial infections | 18 labelers | $1.11 per mL 0.3% eye drop | A presentation being discontinued |
| Dexamethasone and neomycin and polymyxin b | Bacterial infections | 9 labelers | $1.78 per mL Neomyc-polym-dexameth eye drop | No current entry |
| Gentamicin | Bacterial infections | 10 labelers | $0.790 per mL 0.3% eye drop | No current entry |
| Polymyxin b and trimethoprim | Bacterial infections | 10 labelers | $0.452 per mL Polymyxin b-tmp eye drops | No current entry |
| Azithromycin | Bacterial infections | none listed | $98.51 per mL 1% eye drops | A presentation being discontinued |
| Bacitracin, hydrocortisone, neomycin and polymyxin b | Bacterial infections | 1 labeler | $5.52 per gram Neo-bacit-poly-hc eye ointment | No current entry |
| Hydrocortisone and neomycin and polymyxin b | Bacterial infections | 1 labeler | $17.64 per mL Neomycin-poly-hc eye drops | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other sulfonamide antibacterials
- the pharmacologic class, with prices and generics
- Sulfacetamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other