![Tripleantibioticapainscaritch Family Wellness Bacitracin,Neomycin,PolymyxinB,PramoxineHCL 10000 [USP'U]/100g; 500 [USP'U]/100g; 3.5 mg/100g; 10 mg/100g Ointment, 1 tube — NDC 69396-0045-01 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=935106c6-8a9e-07fa-e053-2a95a90a2484&name=family+wellness+pain+itch+scar+1oz.jpg)
Tripleantibioticapainscaritch Family Wellness Bacitracin,Neomycin,PolymyxinB,PramoxineHCL 10000 [USP'U]/100g; 500 [USP'U]/100g; 3.5 mg/100g; 10 mg/100g Ointment, 1 tube
by Trifecta Pharmaceutical USA LLC · 1 TUBE in 1 BOX (69396-045-01) / 28.4 g in 1 TUBE
NDC 69396-0045-01
🏷️ FDA NDC (as labeled)
69396-045-01
billing pads the product 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)
69396-045-01
Product NDC
69396-045
11-digit billing NDC
69396004501
RxCUI
1359350
UNII
19371312D4, 58H6RWO52I, 057Y626693, 88AYB867L5
UPC
0032251533143
Application #
M004
SPL Set ID
935106c6-8a9e-07fa-e053-2a95a90a2484
Physiologic effect
Decreased Cell Wall Synthesis & Repair
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2019-08-30
Route
TOPICAL
Dosage form
OINTMENT
Substance
POLYMYXIN B SULFATE; BACITRACIN; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 69396-045-01 — 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 → 69396-0045-01. 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.
🏭 Manufacturer & labeler
LabelerTrifecta Pharmaceutical USA LLC
FDA applicationM004 (OTC MONOGRAPH DRUG)
Labeler code69396
First marketedAug 2019
Product typeHuman Otc Drug
Portfolio7 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
🧪 What is this product?
This is an over-the-counter topical ointment containing three antibiotics (bacitracin, neomycin, and polymyxin B) and a local anesthetic (pramoxine hydrochloride). The antibiotics are commonly used to help prevent or treat minor bacterial skin infections, while pramoxine is typically included to numb or reduce itching and pain at the skin surface. This combination product is marketed under FDA's monograph rules for topical antibiotic-anesthetic ointments and is applied directly to affected skin areas.
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 Family Wellness Bacitracin,Neomycin,PolymyxinB,PramoxineHCL?
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 H4N855PNZ1
Alpha-tocopherol is a form of vitamin E, a fat-soluble antioxidant derived from natural or synthetic sources. In medicines, it prevents oils and fats from breaking down and becoming rancid, protecting the product's stability and shelf life.
-
UNII 512OYT1CRR
Cocoa butter is a natural fat extracted from cocoa beans. It's used in medicines as a base for suppositories and as a lubricant to help pills dissolve smoothly.
-
UNII N5CFT140R8
A plant oil derived from cottonseed, used in medicines as a solvent or carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.
-
UNII 6UYK2W1W1E
A natural oil extracted from olives. It acts as an emollient and lubricant in formulations, helping to soften ingredients and improve how the medicine spreads or flows.
-
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 POD38AIF08
Sodium pyruvate is a salt form of pyruvic acid, a naturally occurring compound. It's used in medicines as a buffer to help maintain the product's pH and stability.
6 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesCocoa Butter, Levant Cottonseed Oil, Olive Oil, Petrolatum, Sodium pyruvate, vitamin E
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 | 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.
🔁 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
🏛️
2019
On the market since
Aug 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69396-0045-01 You're viewing this | 1 TUBE in 1 BOX (69396-045-01) / 28.4 g in 1 TUBE | 2019-09-22 | Active |
🧭 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 FDA registers it as 69396-045-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 69396-0045-01, written without dashes as 69396004501. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 69396-0045-01, the first segment (69396) is the labeler code FDA assigned to Trifecta Pharmaceutical USA LLC; the middle segment (0045) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Trifecta Pharmaceutical USA LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Trifecta Pharmaceutical USA 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.
📄 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses Helps prevent infection in and temporarily relieves pain due to minor cuts, scrapes and burns.
⏱️ Dosage and Administration ▾
Directions Adults and children 2 years and older: 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 Children under 2 years: ask a doctor
⚠️ Warnings ▾
Warnings For external use only. Do not use: If you are allergic to any of the ingredients in or near the eyes on large areas of the body
📦 Storage and Handling ▾
Other Information To Open: Unscrew cap, pull tab to remove foil seal Store at 20° to 25°C (68° to 77°F) See carton or tube crimp for lot number and expiration date
🧪 Active Ingredient ▾
Active Ingredient Bacitracin 500 Units
Active Ingredient Neomycin 3.5mg
Active Ingredient Polymyxin B 10,000 Units
Active Ingredient Pramoxine HCL 10mg
🧪 Inactive Ingredients ▾
Inactive Ingredient: Cocoa Butter, Levant Cottonseed Oil, Olive Oil, Petrolatum, Sodium pyruvate, vitamin E
🎯 Purpose ▾
Purpose First Aid Antibiotic
Purpose First Aid Antibiotic
Purpose First Aid Antibiotic
Purpose Pain Reliever
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.