Triple Antibiotic Polymyxin B Sulfate, Bacitracin Zinc and Neomycin Sulfate 5000 [USP'U]/g; 3.5 mg/g; 400 [USP'U]/g Ointment, 1 tube
by Cosette Pharmaceuticals, Inc. · 1 TUBE in 1 CARTON (0713-0268-31) / 28.4 g in 1 TUBE
NDC 00713-0268-31
🏷️ FDA NDC (as labeled)
0713-0268-31
billing pads the labeler segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Aug 27, 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)
0713-0268-31
Product NDC
0713-0268
11-digit billing NDC
00713026831
NCPDP billing unit
GM — per gram (weight)
RxCUI
204602
UNII
19371312D4, 057Y626693, 89Y4M234ES
Application #
M004
SPL Set ID
39893365-c94f-bc83-67f6-0005d5f2aa24
Established class (EPC)
Aminoglycoside Antibacterial; Polymyxin-class Antibacterial
Physiologic effect
Decreased Cell Wall Synthesis & Repair
Chemical class
Aminoglycosides; Polymyxins
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
1995-01-11
Route
TOPICAL
Dosage form
OINTMENT
Substance
POLYMYXIN B SULFATE; NEOMYCIN SULFATE; BACITRACIN ZINC
GPI-14
90109803104200
GPI class
Triple Antibiotic
GCN Seq No
007694
GCN
85459
HICL code
033356
Ingredient (HICL)
Neomycin/Bacitracin/Polymyxinb
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
Q5W
Therapeutic class — specific (HIC3)
Topical Antibiotics
AHFS code
08:12.28.08
AHFS class
Bacitracin Antibiotics
FDB label name
TRIPLE ANTIBIOTIC OINTMENT
FDB brand name
Triple Antibiotic
Legend status
O — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 0713-0268-31 — 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 → 00713-0268-31. 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 Other antibiotics for topical use class.
Drug family (ATC)
Other antibiotics for topical use, Other antibacterials, 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.
🏭 Manufacturer & labeler
LabelerCosette Pharmaceuticals, Inc.
FDA applicationM004 (OTC MONOGRAPH DRUG)
Labeler code00713
First marketedJan 1995
Product typeHuman Otc Drug
Portfolio99 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 TRIPLE ANTIBIOTIC OINTMENT Ingredient Neomycin/Bacitracin/Polymyxinb
📗 Our plain-language guide HelloPharmacist
- It's a first-aid antibiotic you apply to small, everyday wounds — minor cuts, scrapes, and burns — to help prevent a bacterial infection from developing. Some products also help te...
- What is this triple antibiotic ointment actually for?
- Start by cleaning the wound area. Then apply a small amount — about the size of your fingertip — directly on the area up to 1 to 3 times a day. You can cover it with a sterile band...
- Most people don't have any trouble with it. The most common reaction is a mild skin irritation, redness, itching, or swelling at the spot you applied it. If you use it often, you c...
Patient education
Supplement & herbal interactions
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 Polymyxin B Sulfate, Bacitracin Zinc and Neomycin Sulfate?
Ask a pharmacist →
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.
-
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 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.
2 inactive ingredients listed in the exact product block matched to this NDC.
The official label also stateslight mineral oil, white petrolatum
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
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 | $0.111 | $3.15 / 28.4 g |
| Medicaid paysCMS SDUD · 12 mo | $0.3428 | $9.74 / 28.4 g |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
NADAC price history (per g) — tap or hover for the price & month
▲ Up 4% over the last 24 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
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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
🏛️
1995
On the market since
Jan 1995
📍
2026
Currently FDA-listed
31 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 00713-0268-31, 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 – 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
15.9K
Units reimbursed last 4 qtrs
466.2K
Gross reimbursed last 4 qtrs
$159.8K
Avg / prescription
$10.05
Avg / unit
$0.3428
Latest quarter Q4 2025
4.1KRx
Medicaid pays / g
$0.3428
gross reimbursed
vs
NADAC / g
$0.1109
acquisition cost
=
Spread
+$0.2319
+209% 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 ⓘ
Fee-for-service · 10,115 Rx Managed care · 5,791 Rx
State Medicaid map
Units reimbursed · per 100k residents
31.7911
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
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.
🔬 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 Triple Antibiotic (this brand).
Top reported reactions
Reporter sex
Male · 34%
Female · 66%
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00713-0268-31 You're viewing this | 1 TUBE in 1 CARTON (0713-0268-31) / 28.4 g in 1 TUBE | 1995-01-11 | Active |
📄 FDA label — Drug Facts FDA SPL
The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage
⏱️ Dosage and Administration
⚠️ Warnings
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
USES first aid to help prevent infection in minor • cuts • scrapes • burns
⏱️ Dosage and Administration ▾
DIRECTIONS • clean the affected area • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily • may be covered with a sterile bandage
⚠️ Warnings ▾
WARNINGS For external use only Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body • longer than 1 week unless directed by a doctor Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns Stop use and ask a doctor if • the condition persists or gets worse • a rash or other allergic reaction develops
🧪 Active Ingredient ▾
ACTIVE INGREDIENT (in each gram) Bacitracin zinc 400 units Neomycin 3.5 mg Polymyxin B sulfate 5,000 units
🧪 Inactive Ingredients ▾
INACTIVE INGREDIENT light mineral oil, white petrolatum
🎯 Purpose ▾
PURPOSE First aid antibiotic
No label section mentions that — try another word, or open the full label on DailyMed below.
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.