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 Identifiers#

Field, Values table
FieldValues
UniiN6K5787QVP, T5L8T28FGP
Rxcui1236277

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

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