FDA.reportPublic FDA data

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
IngredientStrength
WHITE PETROLATUM83 g/100g
LIGHT MINERAL OIL15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B6E5W8RQJ4Internal UNII lookup
N6K5787QVPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
746083Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
298db04a-21a9-e46e-e063-6294a90acee2Available on FDA.report

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

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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EAR WAX RMVL Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aid9e3cedcc-e523-2653-e053-2a95a90ad1432023-12-15WarningsExact identifier
application number: M014
EarWax Removal Kit Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aidda78ac58-6c1c-4fa9-baac-e9dec02413852023-12-15WarningsExact identifier
application number: M014
Otix Ear wax Removal System Ear wax and BulbCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.15868798-28cd-4495-9baf-711e81ad8bdd2023-12-14WarningsExact identifier
application number: M014
Otix Ear wax Removal DropsCARBAMIDE PEROXIDEBell Pharmaceuticals, Inc.0e70ab09-9360-4ab6-a1fe-6f82af3925812023-12-14WarningsExact identifier
application number: M014
TopCare Earwax Removal DropsCARBAMIDE PEROXIDETopco Associates LLCc5b1ad0e-3712-40fd-afbe-54c0b5f1160b2023-12-14WarningsExact identifier
application number: M014
DG Health Earwax Removal kitCARBAMIDE PEROXIDE 6.5%DOLLAR GENERAL CORPORATION4b6fc00f-72d7-4675-9881-b763f27c06e32023-12-07WarningsExact identifier
application number: M014
Ear Wax Removal Drops EquateCARBAMIDE PEROXIDE - 6.5%WALMART STORES INC33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d2023-12-04WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEProficient Rx LPa131447b-a5a0-45cd-a59c-a9f719275baa2023-12-01WarningsExact identifier
application number: M014
Ear Wax Removal DropsCARBAMIDE PEROXIDE - 6.5%Sheffield Pharmaceuticals LLCaad7e2cd-cb28-423c-a441-eabe6516d40f2022-12-06WarningsExact identifier
application number: M014

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