![topcare triple antibiotic bacitracin zinc, neomycin, polymyxin B 400 [USP'U]/g; 3.5 mg/g; 5000 [USP'U]/g Ointment, 1 tube — NDC 36800-0416-58 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=675665ee-bd0d-4168-81b8-341b1258c102&name=Carton+Image.jpg)
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
topcare triple antibiotic bacitracin zinc, neomycin, polymyxin B 400 [USP'U]/g; 3.5 mg/g; 5000 [USP'U]/g Ointment, 1 tube — NDC 36800-416-58 (Billing 36800-0416-58)
by Topco Associates LLC · 1 TUBE in 1 CARTON / 14.2 g in 1 TUBE
This is a package of 1 tube of topcare triple antibiotic bacitracin zinc, neomycin, polymyxin B 400 [USP'U]/g; 3.5 mg/g; 5000 [USP'U]/g Ointment from Topco Associates LLC, marketed since Feb 2020 and currently FDA-listed.
NDC 36800-0416-58
🏷️ FDA NDC (as labeled)
36800-416-58
billing pads the product segment with a zero
This package
Contains1 tube
Pack sizes3 compare ↓
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 36800-416-58 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 36800 labeler · 416 product · 58 package
- Package marketed since
- Feb 26, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 3680041658 2
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
36800-416-58
Product NDC
36800-416
11-digit billing NDC
36800041658
RxCUI
204602
UNII
89Y4M234ES, 057Y626693, 19371312D4
Application #
M004
SPL Set ID
675665ee-bd0d-4168-81b8-341b1258c102
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
2020-02-26
Route
TOPICAL
Dosage form
OINTMENT
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Quick answers
- RxCUI (RxNorm): 204602
Why two NDCs?
The FDA registers this code as 36800-416-58 — 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 → 36800-0416-58. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
📖 What it is MedlinePlus · NLM
Neomycin, polymyxin, and bacitracin combination is used to prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Neomycin, polymyxin, and bacitracin are in a class of medications called antibiotics. Neomycin, polymyxin, and bacitracin combination works by stopping the growth of bacteria.
Read the full MedlinePlus article ↗📗 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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
💬 Questions about bacitracin zinc, neomycin, polymyxin B?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
ℹ️
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 36800-0416-26 36800-416-26 Main listing | 2 TUBE in 1 CARTON / 56 g in 1 TUBE | 2020-02-26 | — | Active |
| 36800-0416-58 You're viewing this | 1 TUBE in 1 CARTON / 14.2 g in 1 TUBE | 2020-02-26 | — | Active |
| 36800-0416-64 36800-416-64 | 1 TUBE in 1 CARTON / 28 g in 1 TUBE | 2020-02-26 | — | Active |
Pack size FAQ
What quantity is in this package?
This package contains 1 tube — 1 tube in 1 carton / 14.2 g in 1 tube.
What NDC number is used to bill for this package of topcare triple antibiotic bacitracin zinc, neomycin, polymyxin B 400 [USP'U]/g; 3.5 mg/g; 5000 [USP'U]/g Ointment?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2020
On the market since
Feb 2020
📍
2026
Currently FDA-listed
6 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.
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Color
White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
- FDA label on DailyMed · label index refreshed Oct 5, 2026
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.
🧪 Avoiding an ingredient? See Neomycin, Polymyxin, and Bacitracin Topical inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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.
Manufacturer & labeler
LabelerTopco Associates LLC
FDA applicationM004 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedFeb 2020
Product typeHuman Otc Drug
Portfolio408 products on file
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- Calamine Plus Pramoxine HCl Calamine Plus Spray .345 mg/116g; 24.16 mg/116g; 2.72 mg/116g Aerosol, Spray NDC 36800-398-41
- Antifungal Liquid Tolnaftate 10 mg/mL Liquid NDC 36800-399-01
- Antiseptic Skin Cleanser Chlorhexidine Gluconate 4% 4 mg/100mL Liquid NDC 36800-401-50
- Topcare Sinus and Cold D Naproxen sodium, Pseudoephedrine HCl 220 mg; 120 mg Tablet, Film Coated, Extended Release NDC 36800-417-01
- TopCare Effervescent Antacid and Pain Relief Aspirin, Citric Acid, Sodium Bicarbonate 325 mg; 1916 mg; 1000 mg Tablet, Effervescent NDC 36800-421-68
- Topcare Tioconazole 1 6.5 g/100g Ointment NDC 36800-426-54
- topcare sleep aid nighttime Diphenhydramine Hydrochloride 25 mg Tablet, Film Coated NDC 36800-431-62
- Topcare Nasal Decongestant Maximum Strength Non Drowsy Pseudoephedrine HCl 30 mg Tablet, Film Coated NDC 36800-432-62
- Ibuprofen 200 mg Capsule, Liquid Filled NDC 36800-440-29
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 Ask a Doctor Before Use If
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Other Information
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Use 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 Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
(1-800-222-1222)
🧪 Active Ingredient ▾
Active ingredients (in each gram) Bacitracin zinc equivalent to 400 units bacitracin Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 5,000 units as polymyxin B sulfate
🧪 Inactive Ingredients ▾
Inactive ingredients cocoa butter, cottonseed oil, olive oil, sodium pyruvate, tocopheryl acetate, white petrolatum
🎯 Purpose ▾
Purpose First aid antibiotic
📄 Do Not Use ▾
Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
📄 Other Information ▾
Other information • store at 20-25°C (68-77°F)
📄 Questions or Comments ▾
Questions or comments? 1-888-423-0139
📄 Package Label / Principal Display Panel ▾
Package/Label Principal Display Panel COMPARE TO NEOSPORIN® ACTIVE INGREDIENTS First Aid Antibiotic Ointment Helps Prevent Infection in Minor Cuts, Scrapes & Burns Original Strength TopCare ® health ORIGINAL STRENGTH Triple Antibiotic Ointment BACITRACIN ZINC, NEOMYCIN SULFATE & POLYMYXIN B SULFATE First Aid Antibiotic Ointment NET WT
0.5OZ (14.2 g) TOPCARE TRIPLE ANTIBIOTIC CARTON IMAGE
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 ↗
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 topcare triple antibiotic (this brand).
Top reported reactions
Reporter sex
Female · 100%
Serious outcomes
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.
About this NDC listing & data coverage
Over-the-counter (OTC) product
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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| 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) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Topco Associates LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 1 tube (36800-0416-64), 2 tubes (36800-0416-26). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Topco Associates LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
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.