FDA.reportPublic FDA data

retaine MGD

Product NDC
54799-917
11-digit product format
547990917
Labeler code
54799
Product ID
54799-917_e5019f11-7124-4184-8481-8a1977cd186e
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
OCuSOFT LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-05
Substance
LIGHT MINERAL OIL; MINERAL OIL
Active strength
2; 2 mg/.4mL; mg/.4mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
retaine MGD
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIGHT MINERAL OIL2 mg/.4mL
MINERAL OIL2 mg/.4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N6K5787QVPInternal UNII lookup
T5L8T28FGPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1236277Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06f57d46-96c7-4093-84aa-874ff4b2131dAvailable on FDA.report

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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIGHT MINERAL OILACTIVE INGREDIENTN6K5787QVPRETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.]3
MINERAL OILACTIVE INGREDIENTT5L8T28FGPRETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.]3
LIGHT MINERAL OILACTIVE MOIETYN6K5787QVPRETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.]3
MINERAL OILACTIVE MOIETYT5L8T28FGPRETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.]3
CETALKONIUM CHLORIDEINACTIVE INGREDIENT85474O1N9DRETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXRETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.]3
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGRETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.]3
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VRETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.]3
TROMETHAMINE HYDROCHLORIDEINACTIVE INGREDIENT383V75M34ERETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.]3
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56RETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RRETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54799-917RETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.]6Current NDC, Legacy NDC, 2 package rows20240806_06f57d46-96c7-4093-84aa-874ff4b2131d.zip

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 9 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medics Choice Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMK.C. Pharmaceuticals, Inc.9ddfc275-602f-413b-e053-2995a90a11cb2025-12-30WarningsExact identifier
application number: M018
Medics Choice Eye Drops Seasonal ReliefTETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEKC Pharmaceuticals, Inc.92bd8cb4-90ad-4a47-afa4-30d1fa658d622025-12-30WarningsExact identifier
application number: M018
DG Health Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLDolgencorp LLC9c62f8a3-7cf5-40f9-e053-2a95a90afd862025-12-30WarningsExact identifier
application number: M018
Medics Choice Eye Drops Original Redness RelieverTETRAHYDROZOLINE HYDROCHLORIDEKC Pharmaceuticals, Inc.e42cb1bf-b985-4a1b-9a9b-ac27c2a5d7be2025-12-30WarningsExact identifier
application number: M018
Medics Choice Eye Drops Maximum Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDEK.C. Pharmaceuticals, Inc.f7131707-47af-d70a-e053-6394a90a418f2025-12-30WarningsExact identifier
application number: M018
DG Original Eye DropsTETRAHYDROZOLINE HCLDolgencorp LLC9cb2123c-3ed4-ce8f-e053-2995a90a0ab82025-12-30WarningsExact identifier
application number: M018
Artificial TearsPOLYVINYL ALCOHOL, POVIDONEKC Pharmaceuticals, Inc.eb6eb6c4-1609-407b-84e4-c7509811f3c02025-12-30WarningsExact identifier
application number: M018
Medics Choice Eye Drops AdvancedTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONEKC Pharmaceuticals, Inc.ab906fd8-265c-4359-a920-d626366e245c2025-12-30WarningsExact identifier
application number: M018
Medics Choice Fresh and Soothe Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKC Pharmaceuticals, Inc.1f65b91a-4eac-65c2-e063-6394a90a02952025-12-30WarningsExact identifier
application number: M018
DG Health Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYPROPYLENE GLYCOL 400Dolgencorp LLC9cb20c3b-bf6d-8c7c-e053-2995a90aa4852025-12-30WarningsExact identifier
application number: M018
DG Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLDolgencorp LLC9cb27899-6c36-3c37-e053-2995a90a1d432025-12-30WarningsExact identifier
application number: M018
Publix Artificial Tears Eye DropsPOLYVINYL ALCOHOL, POVIDONEPublix Super Markets, Inc.f5d1394b-0fe8-c372-e053-2a95a90a1f782025-12-30WarningsExact identifier
application number: M018
Best Choice Artificial TearsPOLYVINYL ALCOHOL, POVIDONEBest Choicef5ba63f3-7966-81fe-e053-2995a90a342c2025-12-30WarningsExact identifier
application number: M018
DG Maximum Strength Redness ReliefGLYCERIN, NAPHAZOLINE HCLDolgencorp, Inc9cb261ed-b708-1189-e053-2a95a90a547d2025-12-30WarningsExact identifier
application number: M018
Publix Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEPublix Super Markets, Inc.f7b0c3d6-0324-46c3-e053-6394a90a82412025-12-30WarningsExact identifier
application number: M018
Publix Moisturizing Relief Eye DropsCARBOXYMETHYLCELLULOSE SODIUMPublix Super Markets, Inc.9b391400-c53b-7c7b-e053-2995a90a27312025-12-30WarningsExact identifier
application number: M018
Publix High Performance Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLPublix Super Markets, Inc.9b402aa8-87cb-3928-e053-2995a90afa3c2025-12-30WarningsExact identifier
application number: M018
Kroger Eye Drops Artificial TearsPOLYVINYL ALCOHOL, POVIDONEThe Kroger Companyf76f08c5-0111-8bc5-e053-6294a90a16ee2025-12-30WarningsExact identifier
application number: M018
Health Mart Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCc8be678f-2b4a-4d39-9cb4-910d36d721742025-12-30WarningsExact identifier
application number: M018
Winco Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HCLWinCo Foods, LLCff3651d4-42ce-4db1-a318-15f7592baf862025-12-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1236277light mineral oil 0.5 % / mineral oil 0.5 % Ophthalmic SolutionPSN06f57d46-96c7-4093-84aa-874ff4b2131d8
1236277mineral oil 5 MG/ML / mineral oil, light 5 MG/ML Ophthalmic SolutionSCD06f57d46-96c7-4093-84aa-874ff4b2131d8
1236277mineral oil 0.5 % / mineral oil light 0.5 % Ophthalmic DropsSY06f57d46-96c7-4093-84aa-874ff4b2131d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54799-917-305479909173030 VIAL, SINGLE-DOSE in 1 CONTAINER (54799-917-30) / .4 mL in 1 VIAL, SINGLE-DOSE2012-01-050000-00-00NoNoCurrent