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

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 1 of 26 · 512 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
application number: M018
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
application number: M018
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
application number: M018
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5967ef02-6770-bfd7-e063-6294a90a79042026-08-19WarningsExact identifier
application number: M018
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
application number: M018
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
application number: M018
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
application number: M018
Mineral Oil/White PetrolatumMINERAL OIL/WHITE PETROLATUMYYBA CORP5905b300-6f1f-a61f-e063-6394a90a11232026-08-14WarningsExact identifier
application number: M018
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
application number: M018
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
application number: M018
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
application number: M018
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
application number: M018
VedlubeMINERAL OIL AND WHITE PETROLATUM LUBRICANT EYE OINTMENTVEDCO INC55d126fa-7489-4307-824e-b6957e57d4e92026-07-31WarningsExact identifier
application number: M018
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
application number: M018
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
application number: M018
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
application number: M018
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
application number: M018
Polyvinyl AlcoholPOLYVINYL ALCOHOLAvPAKf18b61da-4033-341a-e053-2a95a90a8ebf2026-07-07WarningsExact identifier
application number: M018
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact 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