NDC 54312-0019-31 — VITACILINA NEOMYCIN SULFATE FIRST AID

🆔 Identity & classification

FDA NDC (as labeled) 54312-019-31

Product NDC 54312-019

11-digit billing NDC 54312001931

RxCUI 1544556

UNII 057Y626693

UPC 0348875019315, 0348875019353

Application # M004

SPL Set ID ba7a3331-466e-496f-bebd-9ee7067bcdb2

Established class (EPC) Aminoglycoside Antibacterial

Chemical class Aminoglycosides

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2016-07-30

Route TOPICAL

Dosage form OINTMENT

Substance NEOMYCIN SULFATE

Why two NDCs? The FDA registers this code as 54312-019-31 — 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 → 54312-0019-31. 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 Aminoglycoside Antibacterial class.

Pharmacologic class Aminoglycoside Antibacterial

Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Antibiotics, Antiinfectives

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

LabelerCompania Internacional de Comercio, S.A.P.I de C.V.

FDA applicationM004 (OTC MONOGRAPH DRUG)

Labeler code54312

First marketedJul 2016

Product typeHuman Otc Drug

Portfolio4 products on file

🔎 All NDCs from Compania Internacional de Comercio, S.A....

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 it is MedlinePlus · NLM

Neomycin, an antibiotic, is used to prevent or treat skin infections caused by bacteria. It is not effective against fungal or viral infections. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

It's a first-aid antibiotic you put directly on the skin to help prevent infection in minor cuts, scrapes, and small burns. It's not meant for serious wounds or large areas of the...
Apply it directly to the affected area of skin. Follow the directions on your specific product label for how often to use it. As a general rule, don't use it for more than one week...
The main thing to watch for is a rash or any sign of an allergic reaction — like increased redness, swelling, or itching at or near the application site. If that happens, stop usin...
What should I watch out for while using it?

📖 Read our full Neomycin Topical guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

10

Nutrient depletion considerations

Neomycin may be associated with lower levels of 10 nutrients — worth a chat with your pharmacist, not a cause for alarm.

BETA-CAROTENE Insignificant Depletion BIOTIN Insignificant Depletion FOLIC ACID Insignificant Depletion RIBOFLAVIN Insignificant Depletion THIAMINE Insignificant Depletion +5 more

🧪 Full Neomycin nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

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.

🧪 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 7EV65EAW6H
Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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 Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
UNII 1D1K0N0VVC
A fat-soluble form of vitamin A used as a colorant and nutritional fortification ingredient. It gives products a yellow or orange tint and increases vitamin A content in the formula.

5 inactive ingredients listed in the exact product block matched to this NDC.

The official label also stateslanolin, methylparaben, petrolatum, propylparaben, vitamin A palmitate

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.

Try another pack size: 14 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Pomada Sulfa First Aid Antibiotic .5 g/100g 48201-0104-40	GRANDALL	40 g	—	—	FDA listed	—
Vitacilina Neomycin Sulfate First Aid Antibiotic 3.5 mg/gthis 54312-0019-31	Compania	1 tube	—	—	FDA listed	—
Neomycin 5 mg/g 67777-0218-01	Dynarex	10 packets	—	—	FDA listed	—
First Aid Only Neomycin Antibiotic 3.5 mg/g 00924-5620-00	Acme	9 g	—	—	FDA listed	—
Antibiotic 3.5 mg/g 55550-0730-21	Total	9 g	—	—	FDA listed	—
Pomada de Sulfa 3.5 mg/g 53145-0056-02	Menper	1 jar	—	—	FDA listed	—
Single Antibiotic with Neomycin 3.5 mg/g 61010-6700-02	Safetec	144 pouches	—	—	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

🏛️

2016

On the market since

Jul 2016

📍

2026

Currently FDA-listed

10 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Neomycin Sulfate (matched by generic name) — the program that covers self-administered drugs. 3 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Neomycin Sulfate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$282K

Claims incl. refills

26.7K

Beneficiaries

25.4K

Spend / beneficiary

$11.11

Spend / claim

$10.55

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
54312-0019-31 You're viewing this	1 TUBE in 1 CARTON (54312-019-31) / 28 g in 1 TUBE	2016-07-30	Active
54312-0019-35	1 TUBE in 1 CARTON (54312-019-35) / 14 g in 1 TUBE	2016-07-30	Active

Pack size FAQ

What quantity is in NDC 54312-0019-31?

NDC 54312-0019-31 is listed by the FDA — 1 tube in 1 carton / 28 g in 1 tube.

What NDC number is used to bill for this package of VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC 3.5 mg/g Ointment?

Bill NDC 54312-0019-31 — the 11-digit billing format is 54312001931. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 54312-019-31, 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: 54312-0019-31, written without dashes as 54312001931. 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 54312-0019-31, the first segment (54312) is the labeler code FDA assigned to Compania Internacional de Comercio, S.A.P.I de C.V.; the middle segment (0019) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (31) 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 Compania Internacional de Comercio, S.A.P.I de C.V.. 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 (54312-0019-35). 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?

Compania Internacional de Comercio, S.A.P.I de C.V. 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 13 words ▾

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

⏱️ Dosage and Administration 43 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 100 words ▾

Warnings For external use only Do not use • in the eyes • over large areas of the body • if you are allergic to any of the ingredients • 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 16 words ▾

Active ingredient (in each gram) Neomycin sulfate 5 mg (neomycin 3.5 mg) Purpose First aid antibiotic

🧪 Inactive Ingredients 9 words ▾

Inactive ingredients lanolin, methylparaben, petrolatum, propylparaben, vitamin A palmitate

🎯 Purpose 4 words ▾

Purpose First aid antibiotic

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

🔗 Related NDC lookups

🧪 All Neomycin Sulfate NDCsSame ingredient 🏭 All Compania labeler NDCsLabeler code 54312 📚 All Aminoglycoside Antibacterial NDCsDrug class