OFTAL-MYCIN LUBRICANT OPHTHALMIC

Product NDC
48201-301
11-digit product format
482010301
Labeler code
48201
Product ID
48201-301_422c0915-37ab-dfd4-e063-6294a90ac5d3
Type
HUMAN OTC DRUG
Nonproprietary name
LIGHT MINERAL, WHITE PETROLATUM
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
GRANDALL DISTRIBUTING, LLC
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-18
Substance
LIGHT MINERAL OIL; WHITE PETROLATUM
Active strength
15; 83 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OFTAL-MYCIN LUBRICANT OPHTHALMIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIGHT MINERAL OIL15 g/100g
WHITE PETROLATUM83 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN6K5787QVP, B6E5W8RQJ4
Rxcui746083

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48201-301-11OFTAL-MYCIN LUBRICANT OPHTHALMIC3.5 g in 1 BOTTLEOINTMENT3.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48201-301OFTAL-MYCIN LUBRICANT OPHTHALMIC (LIGHT MINERAL, WHITE PETROLATUM) OINTMENT [GRANDALL DISTRIBUTING, LLC]2Current NDC, 1 package rows20250206_298db04a-21a9-e46e-e063-6294a90acee2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
746083mineral oil 15 % / petrolatum 83 % Ophthalmic OintmentPSN298db04a-21a9-e46e-e063-6294a90acee24
746083mineral oil 0.15 MG/MG / petrolatum 0.83 MG/MG Ophthalmic OintmentSCD298db04a-21a9-e46e-e063-6294a90acee24
746083mineral oil 15 % / petrolatum, white 83 % Ophthalmic OintmentSY298db04a-21a9-e46e-e063-6294a90acee24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48201-301-11482010301113.5 g in 1 BOTTLE (48201-301-11) 3.5 g2024-12-18NoNoCurrent