Established class (EPC)Aminoglycoside Antibacterial
Chemical classAminoglycosides
DEA scheduleNon-controlled
Marketing categoryANDA
Marketing statusOn market
FDA listing statusListed (active directory)
Marketing start2014-11-28
RouteTOPICAL
Dosage formOINTMENT
SubstanceGENTAMICIN SULFATE
GPI-1490100050104205
GPI classGentamicin Sulfate
GCN Seq No007725
GCN31800
HICL code004032
Ingredient (HICL)Gentamicin Sulfate
HIC1 codeQ
Therapeutic class — broad (HIC1)Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 codeQ5
Therapeutic class — intermediate (HIC2)Agents Acting Principally On The Skin
HIC3 codeQ5W
Therapeutic class — specific (HIC3)Topical Antibiotics
AHFS code08:12.02.00
AHFS classAminoglycoside Antibiotics
FDB label nameGENTAMICIN 0.1% OINTMENT
FDB brand nameGentamicin Sulfate
Legend statusF — Federal legend — prescription drug or device
TE code (Orange Book)AT · RLD · RS
Why two NDCs?
The FDA registers this code as 0713-0682-31 — a 4-4-2 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 labeler segment → 00713-0682-31. 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 Aminoglycoside Antibacterial class.
Pharmacologic classAminoglycoside Antibacterial
Drug family (ATC)Other antibiotics for topical use, Other aminoglycosides, Antibiotics
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.
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 GENTAMICIN 0.1% OINTMENTIngredient Gentamicin Sulfate
📖 What it is MedlinePlus · NLM
Topical gentamicin is used in adults and children 1 year of age and older to treat skin infections caused by certain bacteria. Topical gentamicin is in a class of medications called antibiotics. It works by killing bacteria that cause infections.
Gentamicin topical is used for a wide range of bacterial skin infections. That includes common ones like impetigo, boils, infected eczema, infected cuts or scrapes, pustular acne,...
What kinds of skin infections does gentamicin topical actually treat?
It depends on the type of skin involved. The cream is better for wet, oozy infections or greasy conditions like infected seborrheic dermatitis or pustular acne — and it's also easi...
Apply a small amount to the affected area three to four times a day. You can cover it with a gauze dressing afterward if you'd like. If you're treating impetigo, gently remove any...
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.
💬 Questions about Gentamicin Sulfate?
Ask a licensed pharmacist directly — free, answered by our team.
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 N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
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.
UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
4 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 DailyMed — 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?
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 system
Per g
Per package
Retail pharmacies payNADAC · weekly
$0.788
$23.65 / 30 g
Medicaid paysCMS SDUD · 12 mo
$1.37
$40.97 / 30 g
Medicare drug plans payPart D · Q2 2026
$1.44
$43.25 / 30 g
NADAC price history (per g) — tap or hover for the price & month
▼ Down 38% over the last 23 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.
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
🏛️
2014
On the market since
Nov 2014
📍
2026
Currently FDA-listed
12 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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 00713-0682-31, 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 – Q1 2026 · 5 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
7K
Units reimbursed last 4 qtrs
265.1K
Gross reimbursed last 4 qtrs
$362K
Avg / prescription
$51.40
Avg / unit
$1.3658
Latest quarter Q1 2026
1.8KRx
Medicaid pays / g
$1.3658
gross reimbursed
vs
NADAC / g
$0.7883
acquisition cost
=
Spread
+$0.5775
+73% 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 ⓘ
56% FFS44% MCO
Fee-for-service · 3,950 Rx Managed care · 3,094 Rx
State Medicaid map
Units reimbursed · per 100k residents
3.3510
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1New York510 /100k
2New Mexico261 /100k
3Illinois186 /100k
4Mississippi151 /100k
5Connecticut137 /100k
6Delaware137 /100k
7Ohio119 /100k
8Michigan117 /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.
Drug total (last 4 qtrs): 15,501 Rx · 443,268 units · $613,801 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 Gentamicin Sulfate — the program that covers self-administered drugs. 10 manufacturers.
⚠️ 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 Gentamicin Sulfate. 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
$3.25M
Claims incl. refills
100.3K
Beneficiaries
78.4K
Spend / beneficiary
$41.48
Spend / claim
$32.41
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 GENTAMICIN SULFATE — the ingredient across all brands.
Top reported reactions
Acute Kidney Injury1,204
Pyrexia896
Renal Failure705
Diarrhoea562
Sepsis508
Condition Aggravated504
Hypotension493
Reporter sex
Serious outcomes
Death2,828
Life-threatening1,944
Disabling628
Reports over time (by year) — tap or hover for the count & year
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.
1 TUBE in 1 CARTON (0713-0682-15) / 15 g in 1 TUBE
$0.9090 / g
$13.63
2017-12-21
Active
00713-0682-31 You're viewing this
1 TUBE in 1 CARTON (0713-0682-31) / 30 g in 1 TUBE
$0.7883 / g
$23.65
2017-12-21
Active
This pack has the lowest per-g cost of the 2 priced pack sizes ($0.7883 NADAC).
This pack accounts for about 45% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 00713-0682-31?
NDC 00713-0682-31 is listed by the FDA — 1 tube in 1 carton / 30 g in 1 tube.
What NDC number is used to bill for this package of Gentamicin Sulfate 1 mg/g Ointment?
Bill NDC 00713-0682-31 — the 11-digit billing format is 00713068231. 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 Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial superinfections of fungal or viral infections. NOTE: Gentamicin Sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections.
It is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. Good results have been obtained in the treatment of infected stasis and other skin ulcers, infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions and wounds from minor surgery. Patients sensitive to neomycin can be treated with Gentamicin Sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic.
Gentamicin sulfate cream is recommended for wet, oozing primary infections, and greasy, secondary infections, such as postular acne or infected seborrheic dermatitis. Gentamicin Sulfate Ointment, USP 0.1% helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. Gentamicin Sulfate Ointment, USP 0.1% has been used successfully in infants over one year of age as well as in adults and children.
⏱️Dosage and Administration86 words▾
DOSAGE AND ADMINISTRATION A small amount of Gentamicin Sulfate Ointment, USP 0.1% should be applied gently to lesions three to four times a day. The area treated may be covered with a gauze dressing, if desired. In impetigo contagiosa, the crusts should be removed before application of Gentamicin Sulfate Ointment, USP 0.1% to permit maximum contact between the antibiotic and the infection.
Care should be exercised to avoid further contamination of the infected skin. Infected stasis ulcers have responded well to Gentamicin Sulfate under gelatin packing.
⛔Contraindications21 words▾
CONTRAINDICATIONS Gentamicin Sulfate Ointment, USP 0.1% is contraindicated in individuals with a history of sensitivity reactions to any of its components.
🤒Adverse Reactions95 words▾
ADVERSE REACTIONS In patients with dermatoses treated with Gentamicin Sulfate, irritation (erythema and pruritus) that did not usually require discontinuance of treatment has been reported in a small percentage of cases. There was no evidence of irritation or sensitization, however, in any of these patients patch-tested subsequently with gentamicin on normal skin. Possible photosensitization has been reported in several patients but could not be elicited in these patients by reapplication of gentamicin followed by exposure to ultraviolet radiation.
To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🧬Clinical Pharmacology122 words▾
CLINICAL PHARMACOLOGY Gentamicin Sulfate is a wide spectrum antibiotic that provides highly effective topical treatment in primary and secondary bacterial infections of the skin. This product may clear infections that have not responded to other topical antibiotic agents. In impetigo contagiosa and other primary skin infections, treatment with a small amount of Gentamicin Sulfate Ointment three to four times daily usually clears the lesions promptly.
In secondary skin infections, the product facilitates the treatment of the underlying dermatosis by controlling the infection. Bacteria susceptible to the action of Gentamicin Sulfate include sensitive strains of Streptococci (group A beta-hemolytic, alphahemolytic), Staphylococcus aureus (coagulase positive, coagulase negative, and some penicillinase-producing strains), and the gram-negative bacteria, Pseudomonas aeruginosa, Aerobacteraerogens, Escherichia coli, Proteus vulgaris and Klebsiellapneumoniae.
📦How Supplied / Storage and Handling48 words▾
HOW SUPPLIED Gentamicin Sulfate Ointment, USP 0.1% is available as follows: 15 g tube (NDC 0713- 0682 -15) 30 g tube (NDC 0713- 0682 -31) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 05/2022 8-0682CPLNC2 VC7635
📋Description54 words▾
DESCRIPTION Gentamicin Sulfate Ointment, USP 0.1% is a wide spectrum antibiotic preparation for topical administration. Each gram of Gentamicin Sulfate Ointment, USP 0.1% contains Gentamicin Sulfate USP equivalent to 1 mg of gentamicin base in a base of light mineral oil and white petrolatum, with 0.5 mg methylparaben and 0.1 mg propylparaben as preservatives.
No label section mentions that — try another word, or open the full label on DailyMed below.
Glossary — plain-language definitions of medical terms used in this label:
contraindicated: Should not be used in that situation, because the risk is considered too high.
Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.
bactericidal: Describes a medicine that kills bacteria outright.
Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.
contact dermatitis: A skin rash caused by touching something that irritates the skin or triggers an allergy.
Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.
dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.
Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.
erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.
Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.
NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.
pruritus: Itching of the skin.
topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.
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.
