FDA.reportPublic FDA data

retaine MGD

Manufacturer
OCuSOFT LLC | OCuSOFT, Inc. | Unither Manufacturing LLC
Effective date
2026-01-15
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:33:26

Label at a glance#

Productretaine MGD
Active ingredientLIGHT MINERAL OIL, MINERAL OIL
Label structure13 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Light Mineral Oil (0.5%)
Mineral Oil (0.5%)

Purpose

OTC - PURPOSE SECTION

Emollient

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For use in the eyes only.

Do not use

OTC - DO NOT USE SECTION

  • if this product changes color.

When using this product

OTC - WHEN USING SECTION

  • do not touch tip of container to any surface to avoid contamination.
  • do not reuse once opened.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you feel eye pain or changes in vision, continued redness or irritation of the eye.
  • the condition worsens or persists for more than 72 hours.

KEEP OUT OF THE REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  • Use only if tamper seals on top and bottom flaps are intact.
  • Drops appear as a milky white emulsion.
  • Store between 15 o-30 oC (59 o-86 oF).

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call (800) 233-5469 M-F 8:30AM-5:30PM CST
or visit www.ocusoft.com

PRINCIPAL DISPLAY PANEL - 30 sterile Single-Dose Containers

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54799-917-30

OCuSOFT ®

MGD™
ADVANCED™

Lubricant Eye Drops

Non-Preserved*
Relieves Irritation
Long-Lasting Comfort

Superior Dry Eye Relief
Without A Prescription

30 Sterile
Single-Dose Vials
0.01 fl oz (0.4 mL) each

Retaine® MGD™ Advanced™ is
a non-preserved* ophthalmic
emulsion that delivers complete
Dry Eye relief utilizing a
proprietary oil in water emulsion
technology (microemulsification)
with electrostatic attraction to
restore the three layers of the
tear film without blurring.

Replenishes LIPID LAYER and
reduces tear evaporation

Adds moisture to AQUEOUS
LAYER

Lubricates and protects
MUCIN LAYER

*Cetrimonium bromide is a cationic
stabilizer and is not added as a
preservative.

Positively Charged
Retaine® MGD™
Droplets

Negatively Charged
Ocular Surface

Use only if twist top of
single-dose vial is intact.

OCuSOFT®
Manufactured for OCuSOFT LLC.
Rosenberg, TX 77471 USA
© 2025 OCuSOFT Inc.
www.ocusoft.com
Patents: www.ocusoft.com/patents

All registered trademarks are property of
OCuSOFT Inc.

Carton Label
Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1236277light mineral oil 0.5 % / mineral oil 0.5 % Ophthalmic SolutionPSN8
1236277mineral oil 5 MG/ML / mineral oil, light 5 MG/ML Ophthalmic SolutionSCD8
1236277mineral oil 0.5 % / mineral oil light 0.5 % Ophthalmic DropsSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54799-917-30retaine MGD30 in 1 CONTAINEREMULSION308
54799-917-30retaine MGD0.4 mL in 1 VIAL, SINGLE-DOSEEMULSION0.48

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54799-917-30EA - Each54799-91712a4c762-6f86-4c50-9420-d3d1bb150a9e12025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIGHT MINERAL OILACTIVE INGREDIENTN6K5787QVP3
MINERAL OILACTIVE INGREDIENTT5L8T28FGP3
LIGHT MINERAL OILACTIVE MOIETYN6K5787QVP3
MINERAL OILACTIVE MOIETYT5L8T28FGP3
CETALKONIUM CHLORIDEINACTIVE INGREDIENT85474O1N9D3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JG3
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2V3
TROMETHAMINE HYDROCHLORIDEINACTIVE INGREDIENT383V75M34E3
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H563
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54799-91754799-917-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
Cetrimonium BromideL64N7M9BWRIACT
GLYCERINPDC6A3C0OXIACT
POLOXAMER 188LQA7B6G8JGIACT
TROMETHAMINE HYDROCHLORIDE383V75M34EIACT
TROMETHAMINE023C2WHX2VIACT
TYLOXAPOLY27PUL9H56IACT
WATER059QF0KO0RIACT
LIGHT MINERAL OILN6K5787QVPACTIB
MINERAL OILT5L8T28FGPACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION/ DROPS / OPHTHALMIC0.8 %w/vExact identifier — unii+route
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION, GEL FORMING / DROPS / OPHTHALMIC1 mgExact identifier — unii+route
10 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route
10 equally ranked IID candidates
TYLOXAPOLTYLOXAPOLY27PUL9H56SUSPENSION/ DROPS / OPHTHALMIC0.3 %w/vExact identifier — unii+route
10 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION / OPHTHALMIC0.75 %w/vExact identifier — unii+route
10 equally ranked IID candidates
TYLOXAPOLTYLOXAPOLY27PUL9H56SUSPENSION / OPHTHALMIC7 mgExact identifier — unii+route
10 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION/ DROPS / OPHTHALMIC0.8 %w/vExact identifier — unii+route
10 equally ranked IID candidates
TYLOXAPOLTYLOXAPOLY27PUL9H56SUSPENSION / OPHTHALMIC7 mgExact identifier — unii+route
10 equally ranked IID candidates
POLOXAMER 188POLOXAMER 188LQA7B6G8JGSOLUTION / OPHTHALMIC0.1 %w/vExact identifier — unii+route
2 equally ranked IID candidates
TYLOXAPOLTYLOXAPOLY27PUL9H56SOLUTION / OPHTHALMIC5 mgExact identifier — unii+route
10 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.8 %w/wExact identifier — unii+route
10 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION / OPHTHALMIC0.75 %w/vExact identifier — unii+route
10 equally ranked IID candidates
TYLOXAPOLTYLOXAPOLY27PUL9H56SUSPENSION/ DROPS / OPHTHALMIC0.3 %w/vExact identifier — unii+route
10 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route
10 equally ranked IID candidates
TYLOXAPOLTYLOXAPOLY27PUL9H56SOLUTION / OPHTHALMIC5 mgExact identifier — unii+route
10 equally ranked IID candidates
POLOXAMER 188POLOXAMER 188LQA7B6G8JGSOLUTION / OPHTHALMIC0.1 %w/vExact identifier — unii+route
2 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION, GEL FORMING / DROPS / OPHTHALMIC1 mgExact identifier — unii+route
10 equally ranked IID candidates
TYLOXAPOLTYLOXAPOLY27PUL9H56GEL / OPHTHALMIC0.05 %w/wExact identifier — unii+route
10 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VSOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.8 %w/wExact identifier — unii+route
10 equally ranked IID candidates
TYLOXAPOLTYLOXAPOLY27PUL9H56SOLUTION/ DROPS / OPHTHALMIC4 mgExact identifier — unii+route
10 equally ranked IID candidates
TYLOXAPOLTYLOXAPOLY27PUL9H56GEL / OPHTHALMIC0.05 %w/wExact identifier — unii+route
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TYLOXAPOLTYLOXAPOLY27PUL9H56SOLUTION/ DROPS / OPHTHALMIC4 mgExact identifier — unii+route
10 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
retaine MGDMINERAL OILOCuSOFT LLC06f57d46-96c7-4093-84aa-874ff4b2131d2026-01-15WarningsExact identifier
ndc (package): 54799-917-30
ndc (product): 54799-917
ndc11 (package): 54799091730
spl id: e5019f11-7124-4184-8481-8a1977cd186e
spl set id: 06f57d46-96c7-4093-84aa-874ff4b2131d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.