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Family Wellness First Aid Antibiotic Family Wellness bacitracin zinc, polymyxin B sulfate 10000 [USP'U]/g; 500 [USP'U]/g Ointment, 1 tube — NDC 69396-037-04 (Billing 69396-0037-04)

by Trifecta Pharmaceuticals USA, LLC · 1 TUBE in 1 BOX / 14.2 g in 1 TUBE

This is a package of 1 tube of Family Wellness First Aid Antibiotic Family Wellness bacitracin zinc, polymyxin B sulfate 10000 [USP'U]/g; 500 [USP'U]/g Ointment from Trifecta Pharmaceuticals USA, LLC, marketed since Aug 2019 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 69396-0037-04
🏷️ FDA NDC (as labeled) 69396-037-04 billing pads the product segment with a zero
This package
Contains1 tube Pack sizes2 compare ↓
Main listing for product 69396-037 · Also comes in: 15 g 69396-037-05
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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) 69396-037-04
Product NDC 69396-037
11-digit billing NDC 69396003704
RxCUI 308512
UNII 19371312D4, 89Y4M234ES
Application # M004
SPL Set ID 9157681a-3ed1-096e-e053-2a95a90a05e3
Established class (EPC) Polymyxin-class Antibacterial
Physiologic effect Decreased Cell Wall Synthesis & Repair
Chemical class Polymyxins
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-08-29
Route TOPICAL
Dosage form OINTMENT
Substance POLYMYXIN B SULFATE; BACITRACIN ZINC
Quick answers
  • RxCUI (RxNorm): 308512
Why two NDCs? The FDA registers this code as 69396-037-04 — 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 → 69396-0037-04. 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

🧪 What is this product?

Family Wellness First Aid Antibiotic is a topical ointment containing two antibacterial agents: bacitracin zinc and polymyxin B sulfate. Both ingredients are typically used in first aid products to help prevent bacterial infection in minor cuts, scrapes, and wounds on the skin. This is an over-the-counter monograph drug, meaning it is regulated under FDA's established guidelines for antibiotic ointments rather than as an individually reviewed product.

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.
Try another pack size: 15 g
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
69396-0037-04 You're viewing this Main listing 1 TUBE in 1 BOX / 14.2 g in 1 TUBE 2020-01-10 — Active
69396-0037-05 69396-037-05 1 TUBE in 1 BOX / 15 g in 1 TUBE 2019-08-30 — Active

Pack size FAQ

What quantity is in this package?
This package contains 1 tube — 1 tube in 1 box / 14.2 g in 1 tube.
What NDC number is used to bill for this package of Family Wellness First Aid Antibiotic Family Wellness bacitracin zinc, polymyxin B sulfate 10000 [USP'U]/g; 500 [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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Double Antibiotic 500 [USP'U]/g; 10000 [USP'U]/g 62011-0097-01 Strategic 1 tube $0.107 — Discontinued —
sunmark double antibiotic 500 [USP'U]/g; 10000 [USP'U]/g 49348-0274-72 Strategic 1 tube $0.115 — Availability likely —
Double Antibiotic 500 [USP'U]/g; 10000 [USP'U]/g 51672-2044-02 Sun 1 tube $0.115 — Availability likely —
Double Antibiotic 500 [USP'U]/g; 10000 [USP'U]/g 70677-1212-01 STRATEGIC 1 tube $0.115 — Availability likely —
Leader Poly Bacitracin 500 [USP'U]/g; 10000 [USP'U]/g 70000-0093-01 Cardinal 1 tube $0.159 — Availability likely —
Double Antibiotic 400 [USP'U]/g; 5000 [USP'U]/g 21922-0092-05 Encube 1 tube — — FDA listed —
Antibiotic 500 [iU]/g; 10000 [iU]/g 51316-0044-01 CVS 1 tube — — FDA listed —
DG Poly Antibiotic First Aid Antibiotic 500 U/g; 10000 U/g 55910-0342-24 Dollar 1 tube — — FDA listed —
Double Antibiotic 500 [USP'U]/g; 10000 [USP'U]/g 58980-0012-01 STRATUS 144 packets — — FDA listed —
doubleantibioticointment 10000 [USP'U]/g; 500 [USP'U]/g 69396-0029-30 Trifecta 1 tube — — FDA listed —
Family Wellness First Aid Antibiotic 10000 [USP'U]/g; 500 [USP'U]/gthis 69396-0037-04 Trifecta 1 tube — — FDA listed —
Polysporin First Aid Antibiotic 500 [USP'U]/g; 10000 [USP'U]/g 69968-0060-01 Kenvue 9 g — — FDA listed —
Simply Neosporin First Aid Antibiotic 500 [iU]/g; 10000 [iU]/g 69968-0612-01 Kenvue 1 tube — — FDA listed —
Leader Poly Bacitracin 500 [USP'U]/g; 10000 [USP'U]/g 70000-0694-01 Cardinal 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
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.

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.

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.

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

LabelerTrifecta Pharmaceuticals USA, LLC
FDA applicationM004 (OTC MONOGRAPH DRUG)
Labeler code69396
First marketedAug 2019
Product typeHuman Otc Drug
Portfolio3 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 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

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

⏱️ Dosage and Administration 40 words ▾

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 41 words ▾

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 puncture wounds animal bites serious burns

🧪 Active Ingredient 9 words ▾

Active Ingredient Bacitracin 500 Units

Active Ingredient Polymyxin B

🧪 Inactive Ingredients 6 words ▾

Inactive Ingredients Mineral Oil, White Petrolatum

🎯 Purpose 8 words ▾

Purpose First Aid Antibiotic

Purpose First Aid Antibiotic

📄 Stop Use and Ask a Doctor If 25 words ▾

Stop use and ask 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 12 words ▾

If swallowed, get medical help or contact a Poison Control Center immediately.

📄 Questions or Comments 66 words ▾

Questions or Comments? Call 1-888-296-9067 Weekdays 9AM to 4PM EST DISTRIBUTED BY: MIDWOOD BRANDS, LLC. 500 Volvo Parkway, Chesapeake, VA. 23320 NOT SATISFIED? Return package and unused product within 30 days to any Family Dollar store for a refund (with receipt) or exchange. This Product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, owner of the registered trademark Polysporin® MADE IN CHINA

📄 Package Label / Principal Display Panel 3 words ▾

FD Double Antibiotic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 — Not published for this NDC No photo available yet for this listing.
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 Trifecta Pharmaceuticals USA, 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 1 other package presentation of this same product, including 1 tube (69396-0037-05). 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?
Trifecta Pharmaceuticals 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.
← 69396-0033-18 · Trifecta 69396-0038-05 · Trifecta →
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.