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Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL Suspension/ Drops, 10 mL — NDC 68071-4229-01 package photo

Neomycin and Polymyxin B Sulfates and Hydrocortisone Neomycin sulfate, Polymyxin B Sulfate 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL Suspension/ Drops, 10 mL

by NuCare Pharmaceuticals,Inc. · 10 mL in 1 BOX (68071-4229-1)
NDC 68071-4229-01
🏷️ FDA NDC (as labeled) 68071-4229-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 68071-4229-1
Product NDC 68071-4229
11-digit billing NDC 68071422901
RxCUI 310687
UNII WI4X0X7BPJ, 057Y626693, 19371312D4
UPC 0368071422917
Application # ANDA064065
SPL Set ID 6296e2ed-336b-b9af-e053-2991aa0aae0c
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1996-08-28
Route AURICULAR (OTIC)
Dosage form SUSPENSION/ DROPS
Substance HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 68071-4229-1 — a 5-4-1 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 package segment → 68071-4229-01. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, moderately potent (group II), Corticosteroids, potent (group III), Corticosteroids for local oral treatment
How it works Corticosteroid Hormone Receptor Agonists
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

LabelerNuCare Pharmaceuticals,Inc.
Application holderBAUSCH AND LOMB INC
FDA applicationANDA064065 (ANDA)
Labeler code68071
First marketedAug 1996
Product typeHuman Prescription Drug
Portfolio1,015 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.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Neomycin, polymyxin, and hydrocortisone otic combination is used to treat outer ear infections caused by certain bacteria. It is also used to treat outer ear infections that can occur after certain types of ear surgery. Neomycin and polymyxin are in a class of medications called antibiotics. They work by stopping the growth of bacteria. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the ear to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗

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.

🧪 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.

💲 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 mLPer 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 · Q2 2026 $5.70 $56.96 / 10 ml
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 24208-0635-62 Bausch 1 bottle $3.789 AT Availability likely —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 3.5 mg/mL; 10000 [USP'U]/mL; 10 mg/mL 61314-0645-11 Sandoz 10 ml $3.789 AT Availability likely —
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 64980-0448-01 Rising 1 bottle $3.789 AT Availability likely —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 50090-0431-00 A-S 1 bottle — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 3.5 mg/mL; 10000 [USP'U]/mL; 10 mg/mL 50090-2365-00 A-S 10 ml — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 50090-6336-00 A-S 1 bottle — AT FDA listed —
Neomycin And Polymyxin B Sulfates And Hydrocortisone 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 60219-2084-06 Amneal 1 bottle — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 63187-0308-10 Proficient 1 bottle — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 3.5 mg/mL; 10000 [USP'U]/mL; 10 mg/mL 63187-0648-10 Proficient 10 ml — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 3.5 mg/mL; 10000 [USP'U]/mL; 10 mg/mL 63629-8844-01 Bryant 10 ml — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mLthis 68071-4229-01 NuCare 10 ml — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 68788-7787-01 Preferred 1 bottle — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 3.5 mg/mL; 10000 [USP'U]/mL; 10 mg/mL 68788-8130-01 Preferred 10 ml — AT FDA listed —
Neomycin and Polymyxin B Sulfates and Hydrocortisone 10 mg/mL; 3.5 mg/mL; 10000 [USP'U]/mL 68788-9924-01 Preferred 1 bottle — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
1996
On the market since
Aug 1996
📍
2026
Currently FDA-listed
30 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🔬 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 Neomycin and Polymyxin B Sulfates and Hydrocortisone (this brand).

Top reported reactions

Ear Discomfort35
Eye Irritation32
Pain21
Incorrect Route Of Drug Administration19
Ear Pain17
Eye Pain17
Hypoacusis16

Reporter sex

0 reports

Serious outcomes

Hospitalization17
Disabling13
Death3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 30 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68071-4229-01 You're viewing this 10 mL in 1 BOX (68071-4229-1) 2018-01-12 Active

🧭 About this NDC listing & data coverage

Finished prescription 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 ✓ Available
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

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 68071-4229-1, 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: 68071-4229-01, written without dashes as 68071422901. 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 68071-4229-01, the first segment (68071) is the labeler code FDA assigned to NuCare Pharmaceuticals,Inc.; the middle segment (4229) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 NuCare Pharmaceuticals,Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NuCare 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 43 words ▾

INDlCATlONS AND USAGE For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.

⏱️ Dosage and Administration 155 words ▾

DOSAGE AND ADMINISTRATION Therapy with this product should be limited to 10 consecutive days. The external auditory canal should be thoroughly cleansed and dried with a sterile cotton applicator. For adults, 4 drops of the suspension should be instilled into the affected ear 3 to 4 times daily.

For infants and children, 3 drops are suggested because of the smaller capacity of the ear canal. The patient should lie with the affected ear upward and then the drops should be instilled. This position should be maintained for 5 minutes to facilitate penetration of the drops into the ear canal.

Repeat, if necessary, for the opposite ear. If preferred, a cotton wick may be inserted into the canal and then the cotton may be saturated with the suspension. This wick should be kept moist by adding further suspension every 4 hours.

The wick should be replaced at least once every 24 hours. SHAKE WELL BEFORE USING.

⛔ Contraindications 25 words ▾

CONTRAINDICATIONS This product is contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections.

⚠️ Warnings 217 words ▾

WARNINGS Neomycin can induce permanent sensorineural hearing loss due to cochlear damage, mainly destruction of hair cells in the organ of Corti. The risk is greater with prolonged use. Therapy should be limited to 10 consecutive days (see PRECAUTIONS - General ).

Patients being treated with eardrops containing neomycin should be under close clinical observation. Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension should not be used in any patient with a perforated tympanic membrane. Discontinue promptly if sensitization or irritation occurs.

Neomycin sulfate may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical neomycin is not known. When using neomycin-containing products to control secondary infection in the chronic dermatoses, such as chronic otitis externa or stasis dermatitis, it should be borne in mind that the skin in these conditions is more liable than is normal skin to become sensitized to many substances, including neomycin.

The manifestation of sensitization to neomycin is usually a low-grade reddening with swelling, dry scaling, and itching; it may be manifested simply as a failure to heal. Periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. These symptoms regress quickly on withdrawing the medication.

Neomycin-containing applications should be avoided for the patient thereafter.

🤒 Adverse Reactions 173 words ▾

ADVERSE REACTIONS Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see WARNINGS ). Adverse reactions have occurred with topical use of antibiotic combinations including neomycin and polymyxin B.

Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. In one clinical study, using a 20% neomycin patch, neomycin-induced allergic skin reactions occurred in two of 2,175 (0.09%) individuals in the general population.

2 In another study, the incidence was found to be approximately 1%. 3 To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Stinging and burning have been reported rarely when this drug has gained access to the middle ear.

🧒 Pediatric Use 55 words ▾

Pediatric Use: The safety and effectiveness of Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension in otitis externa have been established in the pediatric age group 2 years to 16 years of age. There is inadequate data to establish safety and effectiveness in otitis externa for pediatric patients under 2 years of age. 1

🧓 Geriatric Use 50 words ▾

Geriatric Use: Clinical studies of Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🧬 Clinical Pharmacology 124 words ▾

CLINICAL PHARMACOLOGY Corticoids suppress the inflammatory response to a variety of agents and they may delay healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case. The anti-infective components in the combination are included to provide action against specific organisms susceptible to them.

Neomycin sulfate and polymyxin B sulfate together are considered active against the following microorganisms: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species and Pseudomonas aeruginosa . This product does not provide adequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae . The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.

📦 How Supplied / Storage and Handling 57 words ▾

HOW SUPPLIED Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, USP is supplied in a white plastic dropper bottle in the following size: NDC 68071-4229-1 Bottles of 10 mL Storage: Store at 15°-25°C (59°-77°F). Rx only FOR USE IN EARS ONLY DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. KEEP OUT OF REACH OF CHILDREN.

📦 Storage and Handling 27 words ▾

Storage: Store at 15°-25°C (59°-77°F). Rx only FOR USE IN EARS ONLY DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. KEEP OUT OF REACH OF CHILDREN.

📋 Description 216 words ▾

DESCRIPTION Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP, is a sterile antibacterial and anti-inflammatory suspension for otic use. Each mL contains: ACTIVES: Neomycin Sulfate equivalent to 3.5 mg neomycin base, Polymyxin B Sulfate, equal to 10,000 polymyxin B units, and Hydrocortisone, 10 mg (1%); INACTIVES: Cetyl Alcohol (0.9%), Polysorbate 80, Propylene Glycol, Purified Water. Sulfuric Acid may be added to adjust pH (3.0 - 7.0).

PRESERVATIVE ADDED: Thimerosal 0.01%. Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae).

It has a potency equivalent to not less than 600 micrograms of neomycin standard per milligram, calculated on an anhydrous basis. The structural formulae are: Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 , which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae).

It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formulae are: Hydrocortisone 11β, 17, 21-trihydroxypregn-4-ene-3,20-dione, is an anti-inflammatory hormone. Its structural formula is: C 21 H 30 O 5 Mol.

Wt. 362.46 C:\Users\dale.iannettie\Documents\SPL Assignments\Neomycin Polymyxin B Sulfates Hydro Otic Suspension\ac11d9b5-9e09-4b36-8e94-e40e18289468-01.jpg C:\Users\dale.iannettie\Documents\SPL Assignments\Neomycin Polymyxin B Sulfates Hydro Otic Suspension\ac11d9b5-9e09-4b36-8e94-e40e18289468-02.jpg C:\Users\dale.iannettie\Documents\SPL Assignments\Neomycin Polymyxin B Sulfates Hydro Otic Suspension\ac11d9b5-9e09-4b36-8e94-e40e18289468-03.jpg

💬 Information for Patients 53 words ▾

Information for Patients: Avoid contaminating the bottle tip with material from the ear, fingers, or other source. This caution is necessary if the sterility of the drops is to be preserved. If sensitization or irritation occurs, discontinue use immediately and contact your physician. Do not use in the eyes. SHAKE WELL BEFORE USING.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68071-4228-03 · NuCare 68071-4231-01 · NuCare →
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.