![Signature Care Triple Antibiotic Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl 500 [USP'U]/g; 3.5 mg/g; 10000 [USP'U]/g; 10 mg/g Ointment — NDC 21130-0120-58 package photo](https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=46db4b66-85a2-47fc-a643-df6477e2ddff&name=image-01.jpg)
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Signature Care Triple Antibiotic Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl 500 [USP'U]/g; 3.5 mg/g; 10000 [USP'U]/g; 10 mg/g Ointment — NDC 21130-120-58 (Billing 21130-0120-58)
by Safeway · 1 TUBE in 1 CARTON / 14 g in 1 TUBE
This is a package of Signature Care Triple Antibiotic Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl 500 [USP'U]/g; 3.5 mg/g; 10000 [USP'U]/g; 10 mg/g Ointment from Safeway, marketed since May 2017 and currently FDA-listed. It is this product's only package size.
NDC 21130-0120-58
🏷️ FDA NDC (as labeled)
21130-120-58
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 →
NDC database record
One package, one record: these facts belong to NDC 21130-120-58 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 21130 labeler · 120 product · 58 package
- Package marketed since
- May 9, 2017
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 2113012058 2
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
21130-120-58
Product NDC
21130-120
11-digit billing NDC
21130012058
RxCUI
1359350
UNII
89Y4M234ES, 057Y626693, 19371312D4, 88AYB867L5
Application #
M004
SPL Set ID
46db4b66-85a2-47fc-a643-df6477e2ddff
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
2017-05-09
Route
TOPICAL
Dosage form
OINTMENT
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Quick answers
- RxCUI (RxNorm): 1359350
Why two NDCs?
The FDA registers this code as 21130-120-58 — 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 → 21130-0120-58. 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 3, 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?
Signature Care Triple Antibiotic is a topical ointment available over the counter under FDA's OTC drug rules. It contains three antibiotics (bacitracin, neomycin, and polymyxin B) that are typically used to help prevent bacterial infection in minor cuts, scrapes, and wounds. The ointment also includes pramoxine hydrochloride, a local anesthetic commonly used to temporarily numb minor pain and itching associated with skin injuries.
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 3, 2026
💬 Questions about Bacitracin Zinc, Neomycin sulfate, Polymyxin B, Pramoxine HCl?
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 4, 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 |
|---|---|---|---|---|
| 21130-0120-58 You're viewing this Main listing | 1 TUBE in 1 CARTON / 14 g in 1 TUBE | 2017-05-09 | — | Active |
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2017
On the market since
May 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.
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Color
Yellow
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.
- FDA label on DailyMed · label index refreshed Oct 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.
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.- FDA label on DailyMed · label index refreshed Oct 3, 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
LabelerSafeway
FDA applicationM004 (OTC MONOGRAPH DRUG)
Labeler code21130
First marketedMay 2017
Product typeHuman Otc Drug
Portfolio159 products on file
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- Signature Care Omeprazole 20 mg Tablet, Orally Disintegrating, Delayed Release NDC 21130-128-55
- Signature Care Nighttime Severe Cold and Flu Relief Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl 650 mg/30mL; 20 mg/30mL; 12.5 mg/30mL; 10 mg/30mL Solution NDC 21130-129-40
- Gas Relief simethicone 125 mg Tablet, Chewable NDC 21130-135-73
- Signature Care Omeprazole 20 mg Tablet, Delayed Release NDC 21130-137-30
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
📦 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 ▾
Uses first aid to help prevent infection and for temporary relief of pain or discomfort in minor: • cuts • scrapes • burns
⏱️ Dosage and Administration ▾
Directions • adults and children 2 years of age 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 of age: ask a doctor
⚠️ 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 • symptoms persist for more than 1 week, or clear up and occur again within a few days • 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 (1-800-222-1222).
📦 Storage and Handling ▾
Other information • store at 20-25 ° C (68-77 ° F)
🧪 Active Ingredient ▾
Active ingredients (in each gram) Bacitracin zinc 500 units Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 10,000 units as polymyxin B sulfate Pramoxine HCl 10 mg
🧪 Inactive Ingredients ▾
Inactive ingredients cocoa butter, cottonseed oil, olive oil, petrolatum, sodium pyruvate, tocopheryl acetate
🎯 Purpose ▾
Purpose First aid antibiotic External analgesic
📄 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 • symptoms persist for more than 1 week, or clear up and occur again within a few days • 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 right away (1-800-222-1222).
📄 Questions or Comments ▾
Questions or comments? 1-800-719-9260
📄 Package Label / Principal Display Panel ▾
Package/Label Principal Display Panel Compare to Neosporin ® + Pain Itch Scar active ingredients Quality Guaranteed Triple Antibiotic Ointment + Pain – Itch – Scar First aid antibiotic Pain relieving ointment BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCI MULTI-ACTION OINTMENT Maximum strength pain and itch relief NET WT
0.5 OZ (14 g) triple antibiotic ointment image
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 Signature Care Triple Antibiotic (this brand).
Top reported reactions
Reporter sex
Female · 100%
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) | — 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 Safeway. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Safeway 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.