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Triple Antibiotic with Pain Relief bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride 500 [iU]/g; 5 mg/g; 5000 [iU]/g; 10 mg/g Ointment, 28.4 g — NDC 61010-4401-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Triple Antibiotic with Pain Relief bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride 500 [iU]/g; 5 mg/g; 5000 [iU]/g; 10 mg/g Ointment, 28.4 g — NDC 61010-4401-1 (Billing 61010-4401-01)

by Safetec of America, Inc. · 28.4 g in 1 TUBE

This is a package of 28.4 g of Triple Antibiotic with Pain Relief bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride 500 [iU]/g; 5 mg/g; 5000 [iU]/g; 10 mg/g Ointment from Safetec of America, Inc., marketed since Nov 2019 and currently FDA-listed. It is this product's only package size.

NDC 61010-4401-01
🏷️ FDA NDC (as labeled) 61010-4401-1 billing pads the package segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61010-4401-1
Product NDC 61010-4401
11-digit billing NDC 61010440101
RxCUI 2055751
UNII 89Y4M234ES, 057Y626693, 19371312D4, 88AYB867L5
Application # M004
SPL Set ID ca1df4a0-844d-4b1d-b972-f2704a8ebbab
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 2019-11-01
Route TOPICAL
Dosage form OINTMENT
Substance BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 2055751
Why two NDCs? The FDA registers this code as 61010-4401-1 — a 5-4-1 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 package segment → 61010-4401-01. 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.

Clinical

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

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 ↗
🧪 What is this product?

This is an over-the-counter topical ointment containing three antibiotics and a local anesthetic. The bacitracin zinc, neomycin sulfate, and polymyxin b sulfate are antibacterial agents typically used to help prevent infection in minor cuts, scrapes, and wounds. The pramoxine hydrochloride is a local anesthetic commonly used to provide temporary pain relief and itching at the application site. This product is marketed under FDA's over-the-counter monograph rules for first-aid antibiotic ointments.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

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 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
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
61010-4401-01 You're viewing this Main listing 28.4 g in 1 TUBE 2019-11-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Triple Antibiotic with Pain Relief 500 [iU]/g; 5 mg/g; 5000 [iU]/g; 10 mg/gthis 61010-4401-01 Safetec 28.4 g — — FDA listed —
Penimixcina 500 [iU]/g; 5 mg/g; 5000 [iU]/g; 10 mg/g 69729-0615-05 OPMX 1 tube — — FDA listed —
Pentrexcilina Triple Antibiotic Plus Pain Relief 500 [iU]/g; 5 mg/g; 5000 [iU]/g; 10 mg/g 69729-0616-61 OPMX 1 tube — — FDA listed —
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

🏛️
2019
On the market since
Nov 2019
📍
2026
Currently FDA-listed
7 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.

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 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.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesWhite 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.

Manufacturer & labeler

LabelerSafetec of America, Inc.
FDA applicationM004 (OTC MONOGRAPH DRUG)
Labeler code61010
First marketedNov 2019
Product typeHuman Otc Drug
Portfolio33 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.

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Uses First aid to help prevent infection in minor cuts, scrapes, and burns

⏱️ Dosage and Administration 37 words ▾

Directions Clean the affected area. Apply a small amount (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 91 words ▾

Warnings For external use only Do not use In the eyes If you are allergic to any of the ingredients 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, or serious burns Stop use and ask a doctor if The condition persists or gets worse A 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

🧪 Active Ingredient 22 words ▾

Active Ingredients (in each gram) Bacitracin Zinc (500 units) Neomycin Sulfate 5mg (3.5mg Neomycin) Polymyxin B Sulfate (5000 units) Pramoxine Hydrochloride (10mg)

🧪 Inactive Ingredients 4 words ▾

Inactive Ingredients White Petrolatum

🎯 Purpose 12 words ▾

Purpose First Aid Antibiotic First Aid Antibiotic First Aid Antibiotic Pain Reliever

📄 Do Not Use 30 words ▾

Do not use In the eyes If you are allergic to any of the ingredients Over large areas of the body Longer than 1 week unless directed by a doctor

📄 Ask a Doctor Before Use If 17 words ▾

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

📄 Stop Use and Ask a Doctor If 20 words ▾

Stop use and ask a doctor if The condition persists or gets worse A rash or other allergic reaction develops

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

📄 Other Information 6 words ▾

Other Information Store at room temperature

📄 Package Label / Principal Display Panel 47 words ▾

Principal Display Panel - 1 oz. Tube Label Safetec ® Triple Antibiotic Ointment with Pain Relief Net Wt. 1 oz. (28.4g) Reorder No. 53206 Manufactured for: Safetec of America, Inc. Buffalo, NY 14215 | 1-800-456-7077 Made in India KD/503 Principal Display Panel - 1 oz. Tube Label

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 Bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride — the ingredient across all brands.

Top reported reactions

Pneumonia4
Pruritus3
Seasonal Allergy3
Bronchitis2
Covid-192
Dry Skin2
Fall2

Reporter sex

11 reports
Male · 27%
Female · 73%
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 4 2
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.

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) ✓ 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 Safetec of America, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Safetec of America, Inc. 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.
← 61010-4400-01 · Safetec 61010-4403-01 · Safetec →
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.