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retaine MGD Mineral Oil 2 mg/.4mL; 2 mg/.4mL Emulsion, 30 vials — NDC 54799-0917-30 package photo

retaine MGD Mineral Oil 2 mg/.4mL; 2 mg/.4mL Emulsion, 30 vials

by OCuSOFT LLC · 30 VIAL, SINGLE-DOSE in 1 CONTAINER (54799-917-30) / .4 mL in 1 VIAL, SINGLE-DOSE
NDC 54799-0917-30
🏷️ FDA NDC (as labeled) 54799-917-30 billing pads the product segment with a zero
OTC 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) 54799-917-30
Product NDC 54799-917
11-digit billing NDC 54799091730
NCPDP billing unit EA — each (per item)
RxCUI 1236277
UNII N6K5787QVP, T5L8T28FGP
Application # M018
SPL Set ID 06f57d46-96c7-4093-84aa-874ff4b2131d
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-01-05
Route OPHTHALMIC
Dosage form EMULSION
Substance LIGHT MINERAL OIL; MINERAL OIL
GPI-14 81259902850120
GPI class Zytaze
GCN Seq No 069115
GCN 30526
HICL code 038932
Ingredient (HICL) Light Mineral Oil/Min Oil/Pf
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6Y
Therapeutic class — specific (HIC3) Eye Preparations, Miscellaneous (Otc)
AHFS code 52:92.00.00
AHFS class Eent Drugs, Miscellaneous
FDB label name RETAINE MGD EYE DROPS
FDB brand name Retaine Mgd
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 54799-917-30 — 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 → 54799-0917-30. 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.

🏭 Manufacturer & labeler

LabelerOCuSOFT LLC
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code54799
First marketedJan 2012
Product typeHuman Otc Drug
Portfolio5 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

Label name RETAINE MGD EYE DROPS Ingredient Light Mineral Oil/Min Oil/Pf
📗 Our plain-language guide HelloPharmacist
  • That depends on how you take it. If you use a rectal enema, you can expect a bowel movement in about 2 to 15 minutes. If you take the oral liquid, it generally takes 6 to 8 hours —...
  • How long does it take mineral oil to work?
  • You need to be careful here. Mineral oil can change how other drugs are absorbed into your body. The general rule is to take mineral oil at least 2 hours before or after any other...
  • Can I take mineral oil with my other medications?
📖 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.

🧪 Full Mineral Oil 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 L64N7M9BWR
    A positively charged salt derived from a long-chain fatty compound. It acts as a preservative and antimicrobial agent to help prevent bacterial and fungal growth in liquid medicines and personal care products.
  • 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 statesCetrimonium Bromide, glycerin, 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.

💲 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.
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
retaine MGD 2 mg/.4mL; 2 mg/.4mLthis 54799-0917-30 OCuSOFT 30 vials — — FDA listed —
Eyeleve MGD 2 mg/.4mL; 2 mg/.4mL 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

🏛️
2012
On the market since
Jan 2012
📍
2026
Currently FDA-listed
14 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.

🔬 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 retaine MGD (this brand).

Top reported reactions

Fatigue144
Pyrexia142
Headache141
Pain131
Rash127
Nausea125
Pulmonary Embolism113

Age at onset

Neonate1
Child2
Adolescent4
Adult147
Elderly229

Reporter sex

1,342 reports
Male · 41%
Female · 59%
Unknown · 0%

Serious outcomes

Hospitalization572
Death160
Life-threatening66
Disabling35
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 214 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
54799-0917-30 You're viewing this 30 VIAL, SINGLE-DOSE in 1 CONTAINER (54799-917-30) / .4 mL in 1 VIAL, SINGLE-DOSE 2012-01-05 Active

🧭 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 54799-917-30, 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: 54799-0917-30, written without dashes as 54799091730. 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 54799-0917-30, the first segment (54799) is the labeler code FDA assigned to OCuSOFT LLC; the middle segment (0917) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 OCuSOFT LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
OCuSOFT LLC 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 16 words ▾

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

⏱️ Dosage and Administration 19 words ▾

Directions Shake well before using. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

⚠️ Warnings 7 words ▾

Warnings For use in the eyes only.

🧪 Active Ingredient 9 words ▾

Active ingredients Light Mineral Oil (0.5%) Mineral Oil (0.5%)

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients Cetrimonium Bromide, glycerin, poloxamer 188, tris hydrochloride, tromethamine, tyloxapol, water for injection.

🎯 Purpose 2 words ▾

Purpose Emollient

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 54799-0893-05 · OCuSOFT 54799-0920-25 · OCuSOFT →
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.