FDA.reportPublic FDA data

Eyeleve MGD

Product NDC
72347-010
11-digit product format
723470010
Labeler code
72347
Product ID
72347-010_39f8fc59-d38b-74d8-e063-6294a90a6445
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Bruder Healthcare
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-10
Substance
LIGHT MINERAL OIL; MINERAL OIL
Active strength
2; 2 mg/.4mL; mg/.4mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Eyeleve MGD
Listing expiration
2026-12-31

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
72347-010-05Eyeleve MGD0.4 mL in 1 VIAL, SINGLE-DOSEEMULSION0.43
72347-010-05Eyeleve MGD5 in 1 BOXEMULSION53
72347-010-30Eyeleve MGD0.4 mL in 1 VIAL, SINGLE-DOSEEMULSION0.43
72347-010-30Eyeleve MGD30 in 1 BOXEMULSION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72347-010EYELEVE MGD (MINERAL OIL) EMULSION [BRUDER HEALTHCARE]2Current NDC, 4 package rows20250221_145b66e2-00e1-410e-8539-e12ffc4f6f82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1236277light mineral oil 0.5 % / mineral oil 0.5 % Ophthalmic SolutionPSN145b66e2-00e1-410e-8539-e12ffc4f6f823
1236277mineral oil 5 MG/ML / mineral oil, light 5 MG/ML Ophthalmic SolutionSCD145b66e2-00e1-410e-8539-e12ffc4f6f823
1236277mineral oil 0.5 % / mineral oil light 0.5 % Ophthalmic DropsSY145b66e2-00e1-410e-8539-e12ffc4f6f823

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72347-010-05723470010055 VIAL, SINGLE-DOSE in 1 BOX (72347-010-05) / .4 mL in 1 VIAL, SINGLE-DOSE2025-02-10NoNoHistorical
72347-010-307234700103030 VIAL, SINGLE-DOSE in 1 BOX (72347-010-30) / .4 mL in 1 VIAL, SINGLE-DOSE2025-02-10NoNoHistorical