![Antibiotic Bacitracin Zinc, Polymyxin B Sulfate 500 [iU]/g; 10000 [iU]/g Ointment — NDC 51316-0044-01 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=32e92acf-2e48-4933-8e08-e1df650e7d19&name=double-antibiotic-ointment-ene-1.jpg)
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Antibiotic Bacitracin Zinc, Polymyxin B Sulfate 500 [iU]/g; 10000 [iU]/g Ointment — NDC 51316-044-01 (Billing 51316-0044-01)
by CVS PHARMACY, INC · 1 TUBE in 1 CARTON / 28 g in 1 TUBE
This is a package of Antibiotic Bacitracin Zinc, Polymyxin B Sulfate 500 [iU]/g; 10000 [iU]/g Ointment from CVS PHARMACY, INC, marketed since Feb 2022 and currently FDA-listed. It is this product's only package size.
NDC 51316-0044-01
🏷️ FDA NDC (as labeled)
51316-044-01
billing pads the product segment with a zero
🗂️ 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 →
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
51316-044-01
Product NDC
51316-044
11-digit billing NDC
51316004401
RxCUI
308512
UNII
89Y4M234ES, 19371312D4
Application #
M004
SPL Set ID
32e92acf-2e48-4933-8e08-e1df650e7d19
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
2022-02-25
Route
TOPICAL
Dosage form
OINTMENT
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Quick answers
- RxCUI (RxNorm): 308512
Why two NDCs?
The FDA registers this code as 51316-044-01 — 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 → 51316-0044-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 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 is this product?
This is a topical ointment containing two antibiotic ingredients: bacitracin zinc and polymyxin B sulfate. Both are commonly used in over-the-counter first-aid products to help prevent bacterial infection in minor cuts, scrapes, and burns. The ointment is marketed as an OTC monograph drug, meaning it follows FDA's established rules for this class of topical antibiotic products rather than being reviewed as an individual application.
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 1, 2026
💬 Questions about Bacitracin Zinc, Polymyxin B Sulfate?
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
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 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 |
|---|---|---|---|---|
| 51316-0044-01 You're viewing this Main listing | 1 TUBE in 1 CARTON / 28 g in 1 TUBE | 2022-02-25 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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]/gthis 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]/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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2022
On the market since
Feb 2022
📍
2026
Currently FDA-listed
4 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 Sep 3, 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.
💡 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.- FDA label on DailyMed · label index refreshed Oct 1, 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
LabelerCVS PHARMACY, INC
FDA applicationM004 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedFeb 2022
Product typeHuman Otc Drug
Portfolio104 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 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
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses First aid to help prevent infection in cuts scrapes burns
⏱️ Dosage and Administration ▾
Directions clean 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 a rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
🧪 Active Ingredient ▾
Active ingredients (in each gram) Bacitracin zinc, USP 500 units Polymyxin B sulfate, USP 10,000 units
🧪 Inactive Ingredients ▾
Inactive ingredient 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 a 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 (1-800-222-1222) right away.
📄 Questions or Comments ▾
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
📄 Package Label / Principal Display Panel ▾
Principal display panel Compare to the active ingredients in Polysporin®* Poly Bacitracin Antibiotic Ointment BACITRACIN ZINC & POLYMYXIN B SULFATE OINTMENT, USP First aid antibiotic For External Use Only First Aid to Help Prevent Infection in Minor Cuts, Scrapes, and Burns Protection Against Infection *This product is not manufactured or distributed by Johnson & Johnson Consumer, Inc., distributor of Polysporin®. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
Package label CVS HEALTH Antibiotic Ointment Bacitracin Zinc, USP 500 units, Polymyxin B Sulfate, USP 10,000 units
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 Antibiotic (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 33%
Female · 66%
Unknown · 1%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 CVS PHARMACY, INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CVS PHARMACY, 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.
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.