HomeNDC LookupIngredientsSilver Sulfadiazine › 61570-0131-40
SILVADENE silver sulfadiazine 10 mg/g Cream, 400 g — NDC 61570-0131-40 package photo

SILVADENE silver sulfadiazine 10 mg/g Cream, 400 g

by Pfizer Laboratories Div Pfizer Inc · 400 g in 1 JAR (61570-131-40)
NDC 61570-0131-40
🏷️ FDA NDC (as labeled) 61570-131-40 billing pads the product segment with a zero
This package
Contains400 g Cost per g$0.1247 NADAC Per package$49.88 / 400 g Pack sizes7 compare ↓
Also priced by: Medicaid pays $0.1286/unit · Part D plans $0.4439/unit — full pricing hub ↓
Rx only Brand 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) 61570-131-40
Product NDC 61570-131
11-digit billing NDC 61570013140
NCPDP billing unit GM — per gram (weight)
RxCUI 106351, 208186
UNII W46JY43EJR
Application # NDA017381
SPL Set ID c437213a-1cd4-445e-a39f-bbcacb9f746f
Established class (EPC) Sulfonamide Antibacterial
Chemical class Sulfonamides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1973-11-26
Route TOPICAL
Dosage form CREAM
Substance SILVER SULFADIAZINE
GPI-14 90450030003710
GPI class Silvadene
GCN Seq No 007669
GCN 31630
HICL code 003347
Ingredient (HICL) Silver Sulfadiazine
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 84:04.16.00
AHFS class Astringents, Anti-Infective
FDB label name SILVADENE 1% CREAM
FDB brand name Silvadene
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 61570-131-40 — 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 → 61570-0131-40. 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) 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

LabelerPfizer Laboratories Div Pfizer Inc
Application holderKING PHARMACEUTICALS LLC
FDA applicationNDA017381 (NDA)
Labeler code61570
First marketedNov 1973
Product typeHuman Prescription Drug
Portfolio242 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 SILVADENE 1% CREAM Ingredient Silver Sulfadiazine
📖 What it is MedlinePlus · NLM

Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections of second- and third-degree burns. It kills a wide variety of bacteria. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Silver sulfadiazine cream is applied to second- and third-degree burn wounds to help prevent and treat serious infection. It's not a standalone treatment — your care team uses it a...
  • After the wound is cleaned and any dead tissue is removed, the cream is spread in a thin layer — about 1/16 of an inch — directly over the burn area. It's applied once or twice a d...
  • A temporary dip in white blood cells, especially a type called neutrophils, is actually one of the more commonly reported effects — it happens in roughly 1 in 5 patients. The good...
  • My white blood cell count went down — should I be worried?
📖 Read our full Silver Sulfadiazine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Silver Sulfadiazine — 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 gPer package
Retail pharmacies payNADAC · weekly $0.125 $49.88 / 400 g
Medicaid paysCMS SDUD · 12 mo $0.1286 $51.44 / 400 g
Medicare drug plans payPart D · Q2 2026 $0.4439 $177.56 / 400 g
NADAC price history (per g) — tap or hover for the price & month
Nov 2025 Feb 2026 Apr 2026 Jul 2026 $0.125 $0.108
▲ Up 13% over the last 8 months.
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
Silvadene 10 mg/gthis 61570-0131-40 Pfizer 400 g $0.125 AB Availability likely
Silver sulfadiazine 10 mg/g 67877-0124-05 Ascend 50 g $0.255 AB Availability likely +105%
SSD Cream 10 g/1000g 43598-0210-25 Dr 25 g $0.316 AB Availability likely +153%
Silver Sulfadiazine 10 mg/g 59762-0131-00 Mylan 1 tube $0.403 AB Availability likely +223%
Silvadene 10 mg/g 50090-0230-00 A-S 1 tube AB FDA listed
Silver Sulfadiazine 10 mg/g 50090-0607-00 A-S 50 g AB FDA listed
Silver Sulfadiazine 10 mg/g 50090-0717-00 A-S 50 g AB FDA listed
Silver Sulfadiazine 10 mg/g 50090-0763-00 A-S 25 g AB FDA listed
Silver Sulfadiazine 10 mg/g 50090-2152-00 A-S 400 g AB FDA listed
Ssd 10 g/1000g 50090-7447-00 A-S 50 g AB FDA listed
SSD Cream 10 g/1000g 60760-0962-50 St. 50 g AB FDA listed
Silver Sulfadiazine 10 g/1000g 61919-0237-25 DIRECT 25 g AB FDA listed
Silver Sulfadiazine 10 mg/g 63187-0023-25 Proficient 25 g AB FDA listed
Silver Sulfadiazine 10 mg/g 63629-8768-01 Bryant 20 g AB Discontinued
Silver Sulfadiazine 10 mg/g 63629-8769-01 Bryant 25 g AB Discontinued
Silver Sulfadiazine 10 mg/g 63629-8770-01 Bryant 50 g AB Discontinued
Silver Sulfadiazine 10 mg/g 63629-8771-01 Bryant 50 g AB Discontinued
Silver Sulfadiazine 10 mg/g 63629-8772-01 Bryant 85 g AB Discontinued
Silver Sulfadiazine 10 mg/g 63629-8773-01 Bryant 400 g AB Discontinued
Silver Sulfadiazine 10 g/1000g 68071-2473-05 NuCare 50 g AB FDA listed
SSD Cream 10 g/1000g 68071-3867-05 NuCare 50 g AB FDA listed
Thermazene Silver Sulfadiazine 10 mg/g 68788-0600-02 Preferred 25 g AB FDA listed
SSD Cream 10 g/1000g 68788-8074-02 Preferred 25 g AB FDA listed
Silver Sulfadiazine 10 g/1000g 76420-0208-25 Asclemed 25 g AB FDA listed
Silver Sulfadiazine 10 mg/g 80425-0221-01 Advanced 50 g AB FDA listed
Silver Sulfadiazine 10 mg/g 87063-0078-05 Asclemed 50 g AB FDA listed
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
1973
On the market since
Nov 1973
📍
2026
Currently FDA-listed
53 years 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 61570-0131-40, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
43
Units reimbursed last 4 qtrs
16.6K
Gross reimbursed last 4 qtrs
$2.1K
Avg / prescription
$49.50
Avg / unit
$0.1286
Latest quarter Q4 2025
13Rx
Medicaid pays / g
$0.1286
gross reimbursed
vs
NADAC / g
$0.1247
acquisition cost
=
Spread
+$0.0039
+3% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
100% FFS
Fee-for-service · 43 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 16,550 units · 42.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
42.542.5
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 42.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
50 gs61570-0131-50 261 Rx · $4,198
1 tube61570-0131-55 236 Rx · $4,028
1 tube61570-0131-25 101 Rx · $1,515
1 tube61570-0131-20 14 Rx · $399
1 tube61570-0131-85 11 Rx · $283
1000 gs61570-0131-98 No Medicaid data
Drug total (last 4 qtrs): 666 Rx · 43,424 units · $12,552 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Silvadene — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Silvadene. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$15.8K
Claims incl. refills
550
Beneficiaries
510
Spend / beneficiary
$31.00
Spend / claim
$28.75
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 SILVADENE (this brand).

Top reported reactions

Pain152
Fatigue149
Nausea136
Death120
Diarrhoea117
Chronic Kidney Disease109
Dyspnoea105

Age at onset

Neonate6
Child7
Adolescent4
Adult194
Elderly153

Reporter sex

2,257 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization771
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 202 81
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 Per unit Per pack Marketing startStatus
61570-0131-20 1 TUBE in 1 CARTON (61570-131-20) / 20 g in 1 TUBE $0.4328 / g $8.66 1973-11-26 Active
61570-0131-25 1 TUBE in 1 CARTON (61570-131-25) / 25 g in 1 TUBE $0.2886 / g $7.21 2015-05-26 Active
61570-0131-40 You're viewing this 400 g in 1 JAR (61570-131-40) $0.1247 / g $49.88 1973-11-26 Active
61570-0131-50 50 g in 1 JAR (61570-131-50) $0.2447 / g $12.24 1973-11-26 Active
61570-0131-55 1 TUBE in 1 CARTON (61570-131-55) / 50 g in 1 TUBE $0.2447 / g $12.24 2015-05-26 Active
61570-0131-85 1 TUBE in 1 CARTON (61570-131-85) / 85 g in 1 TUBE $0.2732 / g $23.22 1973-11-26 Active
61570-0131-98 1000 g in 1 JAR (61570-131-98) 1973-11-26 Active

This pack has the lowest per-g cost of the 6 priced pack sizes ($0.1247 NADAC).

This pack accounts for about 6.5% of this product's recent Medicaid fills; the largest share goes to the 50 gs pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 61570-0131-40?
NDC 61570-0131-40 contains 400 g — 400 g in 1 jar.
What is the difference between NDC 61570-0131-40 and NDC 61570-0131-50?
Both are SILVADENE silver sulfadiazine 10 mg/g Cream — the drug itself is identical. NDC 61570-0131-40 is the 400 g package, while NDC 61570-0131-50 is the 50 g package. Per-g NADAC also differs: $0.1247 here vs $0.2447 for the 50 g pack.
What NDC number is used to bill for this package of SILVADENE silver sulfadiazine 10 mg/g Cream?
Bill NDC 61570-0131-40 — the 11-digit billing format is 61570013140. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 32 words

INDICATIONS AND USAGE SILVADENE Cream 1% (silver sulfadiazine) is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.

⏱️ Dosage and Administration 167 words

DOSAGE AND ADMINISTRATION Prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain. The burn wounds are then cleansed and debrided, and SILVADENE Cream 1% (silver sulfadiazine) is applied under sterile conditions. The burn areas should be covered with SILVADENE Cream 1% at all times.

The cream should be applied once to twice daily to a thickness of approximately 1/16 inch. Whenever necessary, the cream should be reapplied to any areas from which it has been removed by patient activity. Administration may be accomplished in minimal time because dressings are not required.

However, if individual patient requirements make dressings necessary, they may be used. Reapply immediately after hydrotherapy. Treatment with SILVADENE Cream 1% should be continued until satisfactory healing has occurred, or until the burn site is ready for grafting.

The drug should not be withdrawn from the therapeutic regimen while there remains the possibility of infection except if a significant adverse reaction occurs.

Contraindications 64 words

CONTRAINDICATIONS SILVADENE Cream 1% (silver sulfadiazine) is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation. Because sulfonamide therapy is known to increase the possibility of kernicterus, SILVADENE Cream 1% should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life.

⚠️ Warnings 167 words

WARNINGS Absorption of silver sulfadiazine varies depending upon the percent of body surface area and the extent of the tissue damage. Although few have been reported, it is possible that any adverse reaction associated with sulfonamides may occur. Some of the reactions, which have been associated with sulfonamides, are as follows: blood dyscrasias including agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, and hemolytic anemia; dermatologic and allergic reactions, including life-threatening cutaneous reactions [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and exfoliative dermatitis]; gastrointestinal reactions; hepatitis and hepatocellular necrosis; CNS reactions; and toxic nephrosis.

There is potential cross-sensitivity between silver sulfadiazine and other sulfonamides. If allergic reactions attributable to treatment with silver sulfadiazine occur, continuation of therapy must be weighed against the potential hazards of the particular allergic reaction. Fungal proliferation in and below the eschar may occur.

However, the incidence of clinically reported fungal superinfection is low. The use of SILVADENE Cream 1% (silver sulfadiazine) in some cases of glucose-6-phosphate dehydrogenase-deficient individuals may be hazardous, as hemolysis may occur.

🤒 Adverse Reactions 150 words

ADVERSE REACTIONS Several cases of transient leukopenia have been reported in patients receiving silver sulfadiazine therapy. 1,2,3 Leukopenia associated with silver sulfadiazine administration is primarily characterized by decreased neutrophil count. Maximal white blood cell depression occurs within 2 to 4 days of initiation of therapy.

Rebound to normal leukocyte levels follows onset within 2 to 3 days. Recovery is not influenced by continuation of silver sulfadiazine therapy. An increased incidence of leukopenia has been reported in patients treated concurrently with cimetidine.

Other infrequently occurring events include skin necrosis, erythema multiforme, skin discoloration, burning sensation, rashes, and interstitial nephritis. Reduction in bacterial growth after application of topical antibacterial agents has been reported to permit spontaneous healing of deep partial-thickness burns by preventing conversion of the partial thickness to full thickness by sepsis. However, reduction in bacterial colonization has caused delayed separation, in some cases necessitating escharotomy in order to prevent contracture.

🤰 Pregnancy 86 words

Pregnancy Teratogenic Effects. A reproductive study has been performed in rabbits at doses up to three to ten times the concentration of silver sulfadiazine in SILVADENE Cream 1% and has revealed no evidence of harm to the fetus due to silver sulfadiazine. There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly justified, especially in pregnant women approaching or at term (see CONTRAINDICATIONS ).

🧒 Pediatric Use 15 words

Pediatric Use Safety and effectiveness in pediatric patients have not been established (see CONTRAINDICATIONS ).

🧓 Geriatric Use 67 words

Geriatric Use Of the total number of subjects in clinical studies of SILVADENE Cream 1%, seven percent were 65 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🧬 Clinical Pharmacology ~1 min read

CLINICAL PHARMACOLOGY Silver sulfadiazine has broad antimicrobial activity. It is bactericidal for many gram-negative and gram-positive bacteria as well as being effective against yeast. Results from in vitro testing are listed below.

Sufficient data have been obtained to demonstrate that silver sulfadiazine will inhibit bacteria that are resistant to other antimicrobial agents and that the compound is superior to sulfadiazine. Studies utilizing radioactive micronized silver sulfadiazine, electron microscopy, and biochemical techniques have revealed that the mechanism of action of silver sulfadiazine on bacteria differs from silver nitrate and sodium sulfadiazine. Silver sulfadiazine acts only on the cell membrane and cell wall to produce its bactericidal effect.

Results of In Vitro Testing with SILVADENE ® Cream 1% (silver sulfadiazine) Concentration of Silver Sulfadiazine Number of Sensitive Strains/Total Number of Strains Tested Genus & Species 50 μg/mL 100 μg/mL Pseudomonas aeruginosa 130/130 130/130 Xanthomonas (Pseudomonas) maltophilia 7/7 7/7 Enterobacter species 48/50 50/50 Enterobacter cloacae 24/24 24/24 Klebsiella species 53/54 54/54 Escherichia coli 63/63 63/63 Serratia species 27/28 28/28 Proteus mirabilis 53/53 53/53 Morganella morganii 10/10 10/10 Providencia rettgeri 2/2 2/2 Providencia species 1/1 1/1 Proteus vulgaris 2/2 2/2 Citrobacter species 10/10 10/10 Acinetobacter calcoaceticus 10/11 11/11 Staphylococcus aureus 100/101 100/101 Staphylococcus epidermidis 51/51 51/51 β-Hemolytic Streptococcus 4/4 4/4 Enterococcus species 52/53 53/53 Corynebacterium- diphtheriae 2/2 2/2 Clostridium perfringens 0/2 2/2 Candida albicans 43/50 50/50 Silver sulfadiazine is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.

📦 How Supplied / Storage and Handling 63 words

HOW SUPPLIED SILVADENE Cream 1% (silver sulfadiazine) is available in jars containing 50 g ( NDC 61570-131-50), 400 g ( NDC 61570-131-40), and 1000 g ( NDC 61570-131-98), and tubes containing 20 g ( NDC 61570-131-20), 25 g ( NDC 61570-131-25), 50 g ( NDC 61570-131-55) and 85 g ( NDC 61570-131-85). Store at Controlled Room Temperature 20° to 25°C (68° to 77°F).

📋 Description 81 words

DESCRIPTION SILVADENE Cream 1% is a soft, white, water-miscible cream containing the antimicrobial agent silver sulfadiazine in micronized form, which has the following structural formula: Each gram of SILVADENE Cream 1% contains 10 mg of micronized silver sulfadiazine. The cream vehicle consists of white petrolatum, stearyl alcohol, isopropyl myristate, sorbitan monooleate, polyoxyl 40 stearate, propylene glycol, and water, with methylparaben 0.3% as a preservative. SILVADENE Cream 1% (silver sulfadiazine) spreads easily and can be washed off readily with water.

Chemical Structure

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.