Home NDC 48201-301 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 Ingredient Strength WHITE PETROLATUM 15 g/100g LIGHT MINERAL OIL 83 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination B6E5W8RQJ4 Internal UNII lookup N6K5787QVP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 746083 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 48201-301-11 OFTAL-MYCIN LUBRICANT OPHTHALMIC 3.5 g in 1 BOTTLE OINTMENT 3.5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 48201-301 OFTAL-MYCIN LUBRICANT OPHTHALMIC (LIGHT MINERAL, WHITE PETROLATUM) OINTMENT [GRANDALL DISTRIBUTING, LLC] 2 Current NDC, 1 package rows 20250206_298db04a-21a9-e46e-e063-6294a90acee2.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 7 · 136 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 48201-301-11 48201030111 3.5 g in 1 BOTTLE (48201-301-11) 3.5 g 2024-12-18 No No Current