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 WHITE PETROLATUM; LIGHT MINERAL OIL
Active strength 83; 15 g/100g; g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 83 g/100g LIGHT MINERAL OIL 15 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 6 of 7 · 129 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SuavEar Earwax Removal Aid EARWAX REMOVAL AID NEILMED PHARMACEUTICALS INC c067f1a4-1f67-3f4d-e053-2a95a90a6095 2024-01-11 Warnings Exact identifier application number: M014 Ear Drops Major CARBAMIDE PEROXIDE 6.5% A-S Medication Solutions eb7df1cc-50db-479a-bc1c-dfd7004dd35b 2024-01-08 Warnings Exact identifier application number: M014 Wax B Gone Ear Wax Removal Drops CARBAMIDE PEROXIDE - 6.5% SIGMAR, LLC 3339cac0-8f32-4f71-bef3-dd1524c4b244 2024-01-08 Warnings Exact identifier application number: M014 Ear Drops for Swimmers ISOPROPYL ALCOHOL Pharma Nobis, LLC e42fd693-24ab-0fc0-e053-2995a90ab954 2023-12-26 Warnings Exact identifier application number: M014 LEADER Ear Drops for Swimmers LEADER EAR DROPS FOR SWIMMERS Cardinal Health, 110 dba Leader 874857eb-2a9d-6ef7-e053-2995a90af156 2023-12-22 Warnings Exact identifier application number: M014 Earwax Removal Drops CARBAMIDE PEROXIDE 6.5% Pharma Nobis, LLC e21e114c-99b6-861c-e053-2995a90aeac1 2023-12-22 Warnings Exact identifier application number: M014 Quality Choice Instant Ear Dry ISOPROPYL ALCOHOL Chain Drug Manufacturing Association 9d3c681b-a941-6ddb-e053-2a95a90ad3bf 2023-12-20 Warnings Exact identifier application number: M014 Premiere Value Ear Drops for Swimmers ISOPROPYL ALCOHOL Pharmacy Value Alliance; LLC 9d606fe6-ae57-724f-e053-2a95a90abffe 2023-12-20 Warnings Exact identifier application number: M014 CVS Ear Drops for Swimmers ISOPROPYL ALCOHOL CVS Pharmacy cc4614ee-5d6e-4a07-9826-aff12cc35abd 2023-12-20 Warnings Exact identifier application number: M014 Earwax Removal Drops CARBAMIDE PEROXIDE 6.5% Randob Labs, Ltd. a9904b63-27a4-205c-e053-2995a90af762 2023-12-19 Warnings Exact identifier application number: M014 DDM Ear Drops for Swimmers ISOPROPYL ALCOHOL Discount Drug Mart 5d565cbc-874b-41dc-e053-2991aa0a6787 2023-12-19 Warnings Exact identifier application number: M014 TopCare Swimmers Ear Drops ISOPROPYL ALCOHOL TOPCO ASSOCIATES 9dccbc25-d954-f917-e053-2a95a90a0eff 2023-12-18 Warnings Exact identifier application number: M014 HEB Water Drying Aid ISOPROPYL ALCOHOL H E B 5d5741f8-64fd-0a9a-e053-2991aa0a0b5e 2023-12-18 Warnings Exact identifier application number: M014 Best Choice Earwax Removal Kit CARBAMIDE PEROXIDE Valu Merchandisers, Co. f943ac0e-8171-446d-8c6c-69612b482643 2023-12-15 Warnings Exact identifier application number: M014 Quality Choice Earwax Removal Kit CARBAMIDE PEROXIDE Chain Drug Marketing Association, Inc. ba8d71b5-7f1f-44a5-ac5b-1f7ceeb02875 2023-12-15 Warnings Exact identifier application number: M014 DISCOUNT drug mart FOOD FAIR earwax removal kit CARBAMIDE PEROXIDE Discount Drug Mart 83fdf4d6-3cdf-429d-b53d-80775a35d0c9 2023-12-15 Warnings Exact identifier application number: M014 Discount Drug Mart Earwax Removal Drops CARBAMIDE PEROXIDE Discount Drug Mart e30c943e-bba5-4520-8f83-16bfa29ee1cf 2023-12-15 Warnings Exact identifier application number: M014 HUMCO Ear Drops for Swimmers ISOPROPYL ALCOHOL Humco Holding Group, Inc. 6f7ba0a6-8dad-47d3-b7c1-6cc9a02808b2 2023-12-15 Warnings Exact identifier application number: M014 Earwax Removal Drops CARBAMIDE PEROXIDE 6.5% Humco Holding Group, Inc a8c052d8-fb9c-09f2-e053-2a95a90a37af 2023-12-15 Warnings Exact identifier application number: M014 EAR DRYING AGENT ISOPROPYL ALCOHOL 94.998% GLYCERIN 5% Rite Aid 9b4299af-c1a2-43e6-90d4-25f4c89d1bef 2023-12-15 Warnings Exact identifier application number: M014
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