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Eyeleve MGD Mineral Oil 2 mg/.4mL; 2 mg/.4mL Emulsion, 5 vials — NDC 72347-0010-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Eyeleve MGD Mineral Oil 2 mg/.4mL; 2 mg/.4mL Emulsion, 5 vials — NDC 72347-010-05 (Billing 72347-0010-05)

by Bruder Healthcare · 5 VIAL, SINGLE-DOSE in 1 BOX / .4 mL in 1 VIAL, SINGLE-DOSE

This is a package of 5 vials of Eyeleve MGD Mineral Oil 2 mg/.4mL; 2 mg/.4mL Emulsion from Bruder Healthcare, marketed since Feb 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 72347-0010-05
🏷️ FDA NDC (as labeled) 72347-010-05 billing pads the product segment with a zero
This package
Contains5 vials Pack sizes2 compare ↓
Main listing for product 72347-010 · Also comes in: 30 vials 72347-010-30
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 →

NDC database record

One package, one record: these facts belong to NDC 72347-010-05 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
72347 labeler · 010 product · 05 package
Package marketed since
Feb 10, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7234701005 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72347-010-05
Product NDC 72347-010
11-digit billing NDC 72347001005
RxCUI 1236277
UNII N6K5787QVP, T5L8T28FGP
Application # M018
SPL Set ID 145b66e2-00e1-410e-8539-e12ffc4f6f82
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-10
Route OPHTHALMIC
Dosage form EMULSION
Substance LIGHT MINERAL OIL; MINERAL OIL
Quick answers
  • RxCUI (RxNorm): 1236277
Why two NDCs? The FDA registers this code as 72347-010-05 — 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 → 72347-0010-05. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Mostly for occasional constipation, by mouth or as an enema. Some enemas are also used for fecal impaction or to clear residue after a barium test. One topical product is used for...
  • Take it only at bedtime and not with meals. It usually works in about 6 to 8 hours. An enema usually works within 2 to 15 minutes.
  • Space it out. Take mineral oil 2 or more hours before or after other drugs, since laxatives may affect how they work. Tell me if you take a stool softener.
  • Not longer than 1 week. If constipation continues or your bowel habits suddenly change for 2 weeks, see your doctor.
📖 Read our full Mineral Oil guide →
7
Nutrient depletion considerations

Mineral Oil may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

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.

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 · 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: 30 vials
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
72347-0010-05 You're viewing this Main listing 5 VIAL, SINGLE-DOSE in 1 BOX / .4 mL in 1 VIAL, SINGLE-DOSE 2025-02-10 — Active
72347-0010-30 72347-010-30 30 VIAL, SINGLE-DOSE in 1 BOX / .4 mL in 1 VIAL, SINGLE-DOSE 2025-02-10 — Active

Pack size FAQ

What quantity is in this package?
This package contains 5 vials — 5 vial, single-dose in 1 box / .4 ml in 1 vial, single-dose.
How does this package differ from NDC 72347-0010-30?
Both are Eyeleve MGD Mineral Oil 2 mg/.4mL; 2 mg/.4mL Emulsion — the drug itself is identical. This page's package is the 5 vials one, while NDC 72347-0010-30 is the 30 vials package.
What NDC number is used to bill for this package of Eyeleve MGD Mineral Oil 2 mg/.4mL; 2 mg/.4mL Emulsion?
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
retaine MGD 2 mg/.4mL; 2 mg/.4mL 54799-0917-30 OCuSOFT 30 vials — — FDA listed —
Eyeleve MGD 2 mg/.4mL; 2 mg/.4mLthis 72347-0010-05 Bruder 5 vials — — 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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year 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.

What it looks like

Color white
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.

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.

🧪 Avoiding an ingredient? See Mineral Oil inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 85474O1N9D
    A synthetic antimicrobial compound used as a preservative in liquid medicines and solutions. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII LQA7B6G8JG
    A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
  • UNII 023C2WHX2V
    Tromethamine is a chemical buffer that helps maintain the proper acidity level in liquid medicines. It neutralizes acids and stabilizes the solution so the medication remains effective and safe throughout its shelf life.
  • UNII 383V75M34E
    A salt form of tromethamine, an organic base compound. It functions as a buffer to help maintain the medicine's pH level and improve stability during storage.
  • UNII Y27PUL9H56
    Tyloxapol is a synthetic detergent and surfactant used in medications as a solubilizer and emulsifier. It helps dissolve or blend ingredients that don't naturally mix well, improving how the medicine disperses in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesCetalkonium Chloride, Glycerol, Poloxamer 188, Tris Hydrochloride, Tromethamine, Tyloxapol, Water for Injection

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

LabelerBruder Healthcare
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code72347
First marketedFeb 2025
Product typeHuman Otc Drug
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 16 words ▾

Uses For use as a protectant against further irritation or to relieve dryness of the eye.

⏱️ Dosage and Administration 25 words ▾

Directions Shake well before using. To open, completely twist off cap. Instill 1 to 2 drops in the affected eye(s) as needed and discard container.

⚠️ Warnings 7 words ▾

Warnings For use in the eyes only.

🧪 Active Ingredient 10 words ▾

Active Ingredients Purpose Light Mineral Oil (0.5%)............................Emollient Mineral Oil (0.5%)......................................Emollient

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients Cetalkonium Chloride, Glycerol, Poloxamer 188, Tris Hydrochloride, Tromethamine, Tyloxapol, Water for Injection

📄 Do Not Use 8 words ▾

Do not use If this product changes color.

📄 When Using This Product 21 words ▾

When using this product Do not touch tip of container to any surface to avoid contamination. Do not reuse once opened.

📄 Stop Use and Ask a Doctor If 32 words ▾

Stop use and ask a doctor if You feel eye pain or changes in vision, continued irritation or redness of the eye. The condition worsens or persists for more than 72 hours.

📄 Keep Out of Reach of Children 18 words ▾

KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center immediately.

📄 Questions or Comments 6 words ▾

Questions? Call 888-965-8006 or visit www.eyeleve.com

📄 Package Label / Principal Display Panel 102 words ▾

PRINCIPAL DISPLAY PANEL - 5 Sterile Single-Dose Containers NDC – 72347-010-05 INSTANT DRY EYE RELIEF eyeleve ® MGD by Bruder ® NEW Preservative-Free Moisture-Rich Formula Provides Soothing Comfort Relieves Irritation 5 Sterile Single-Dose Containers 0.01 fl oz (0.4mL) ea. PROFESSIONAL SAMPLE – NOT FOR RESALE PRINCIPAL DISPLAY PANEL - 5 Sterile Single-Dose Containers

PRINCIPAL DISPLAY PANEL - 30 Sterile Single-Dose Containers NDC 72347-010-30 LUBRICANT EYE DROPS eyeleve ® MGD by Bruder ® NEW INSTANT DRY EYE RELIEF Preservative-Free Moisture-Rich Formula Provides Soothing Comfort Relieves Irritation 30 Sterile Single-Dose Containers 0.01 fl oz (0.4mL) ea. PRINCIPAL DISPLAY PANEL - 30 Sterile Single-Dose Containers

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 Eyeleve MGD (this brand).

Top reported reactions

Pyrexia142
Fatigue137
Headache127
Pain125
Rash121
Nausea117
Pulmonary Embolism112

Age at onset

Neonate1
Child2
Adolescent4
Adult100
Elderly145

Reporter sex

1,146 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization557
Death160
Life-threatening65
Disabling28
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 132 60
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 Bruder Healthcare. 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 30 vials (72347-0010-30). 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?
Bruder Healthcare 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.