Home › NDC Lookup › Ingredients › Bacitracin Zinc And Polymyxin B Sulfate › 58980-0012-01
Double Antibiotic BACITRACIN ZINC and POLYMYXIN B SULFATE 500 [USP'U]/g; 10000 [USP'U]/g Ointment, 144 packets — NDC 58980-0012-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Double Antibiotic BACITRACIN ZINC and POLYMYXIN B SULFATE 500 [USP'U]/g; 10000 [USP'U]/g Ointment, 144 packets — NDC 58980-012-01 (Billing 58980-0012-01)

by STRATUS PHARMACEUTICALS INC · 144 PACKET in 1 BOX / .9 g in 1 PACKET

This is a package of 144 packets of Double Antibiotic BACITRACIN ZINC and POLYMYXIN B SULFATE 500 [USP'U]/g; 10000 [USP'U]/g Ointment from STRATUS PHARMACEUTICALS INC, marketed since Sep 2017 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 58980-0012-01
🏷️ FDA NDC (as labeled) 58980-012-01 billing pads the product segment with a zero
This package
Contains144 packets Pack sizes3 compare ↓
Main listing for product 58980-012 · Also comes in: 14.2 g 58980-012-05 28.35 g 58980-012-10
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

NDC database record

One package, one record: these facts belong to NDC 58980-012-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
58980 labeler · 012 product · 01 package
Package marketed since
Sep 15, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
144 EA per package
Barcode (UPC-A, from the NDC)
3 5898001201 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58980-012-01
Product NDC 58980-012
11-digit billing NDC 58980001201
NCPDP billing unit EA — each (per item)
RxCUI 308512
UNII 89Y4M234ES, 19371312D4
Application # M004
SPL Set ID f64b3564-ea3c-4316-8f00-f92c08dcad35
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 2017-09-15
Route TOPICAL
Dosage form OINTMENT
Substance BACITRACIN ZINC; POLYMYXIN B SULFATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90109802104200
GPI class Double Antibiotic
GCN Seq No 080569
GCN 47451
HICL code 007495
Ingredient (HICL) Bacitracin Zinc/Polymyxin B
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 84:04.04.00
AHFS class Antibacterials (84:04)
FDB label name DOUBLE ANTIBIOTIC OINT PKT
FDB brand name Double Antibiotic
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 080569
  • GCN: 47451
  • GPI-14 (Medi-Span): 90109802104200
  • HICL (First Databank): 007495
  • AHFS class code: 84:04.04.00
  • RxCUI (RxNorm): 308512
Why two NDCs? The FDA registers this code as 58980-012-01 — 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 → 58980-0012-01. 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

Label name DOUBLE ANTIBIOTIC OINT PKT Ingredient Bacitracin Zinc/Polymyxin B
🧪 What is this product?

This is an over-the-counter topical ointment containing two antibacterial ingredients: bacitracin zinc and polymyxin B sulfate. Both are typically used in first-aid products applied to the skin to help prevent bacterial infection in minor cuts, scrapes, and wounds. The ointment is marketed as an OTC monograph drug, meaning it follows FDA's established safety and efficacy standards for this category of topical antibiotic products.

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: 14.2 g 28.35 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
58980-0012-01 You're viewing this Main listing 144 PACKET in 1 BOX / .9 g in 1 PACKET 2017-09-15 — Active
58980-0012-05 58980-012-05 1 TUBE in 1 BOX / 14.2 g in 1 TUBE 2021-02-08 — Active
58980-0012-10 58980-012-10 1 TUBE in 1 BOX / 28.35 g in 1 TUBE 2026-01-26 — Active

Pack size FAQ

What quantity is in this package?
This package contains 144 packets — 144 packet in 1 box / .9 g in 1 packet.
How does this package differ from NDC 58980-0012-05?
Both are Double Antibiotic BACITRACIN ZINC and POLYMYXIN B SULFATE 500 [USP'U]/g; 10000 [USP'U]/g Ointment — the drug itself is identical. This page's package is the 144 packets one, while NDC 58980-0012-05 is the 1 tube package.
What NDC number is used to bill for this package of Double Antibiotic BACITRACIN ZINC and POLYMYXIN B SULFATE 500 [USP'U]/g; 10000 [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]/gthis 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]/g 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

🏛️
2017
On the market since
Sep 2017
📍
2026
Currently FDA-listed
9 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

LabelerSTRATUS PHARMACEUTICALS INC
FDA applicationM004 (OTC MONOGRAPH DRUG)
Labeler code58980
First marketedSep 2017
Product typeHuman Otc Drug
Portfolio8 products on file

More NDCs from STRATUS PHARMACEUTICALS INC labeler code 58980

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 📦 Storage and Handling 🧪 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 📄 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 93 words ▾

Warnings for external use only Allergy alert Do not use if allergic to any of the ingredients Do not use 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

📦 Storage and Handling 31 words ▾

Other information Before using any medication, read all directions Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]

🧪 Active Ingredient 22 words ▾

Active ingredient (in each gram) Purpose Bacitracin Zinc 500 units First Aid Double Antibiotic Polymyxin B 10,000 units First Aid Double Antibiotic

🧪 Inactive Ingredients 4 words ▾

Inactive ingredients White Petrolatum

🎯 Purpose 22 words ▾

Active ingredient (in each gram) Purpose Bacitracin Zinc 500 units First Aid Double Antibiotic Polymyxin B 10,000 units First Aid Double Antibiotic

📄 Do Not Use 21 words ▾

Do not use in the eyes over large areas of the body longer than 1 week unless directed by a doctor

📄 Ask a Doctor Before Use If 16 words ▾

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

📄 Questions or Comments 8 words ▾

Questions or comments? Call Customer Service at 1-800-442-7882

📄 Package Label / Principal Display Panel 44 words ▾

PRINCIPAL DISPLAY PANEL - 28.35 gm Tube Box NDC 58980-012-10 STRATUSCARE Double Antibiotic Ointment (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP) First Aid Antibiotic Net Wt.

1.0OZ (28.35 gm) Distributed by: STRATUS PHARMACEUTICALS INC PRINCIPAL DISPLAY PANEL - 28.35 gm Tube Box

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 ✓ 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 STRATUS PHARMACEUTICALS INC. 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 (58980-0012-05), 1 tube (58980-0012-10). 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?
STRATUS PHARMACEUTICALS 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.
← 58980-0011-01 · STRATUS
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.