FDA.reportPublic FDA data

Antibiotic

Product NDC
67510-0066
11-digit product format
675100066
Labeler code
67510
Product ID
67510-0066_680ad969-184e-6b19-e053-2991aa0a9343
Type
HUMAN OTC DRUG
Nonproprietary name
Neomycin Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Kareway Product, Inc.
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-11
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE
Active strength
4 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67510-0066-12020-09-27C16284748780-1ab0e2407-27c4-f274-e053-dbdaa90a6471Drug Facts
67510-0066-12020-09-25C16284748780-1ab0e2407-27c4-f274-e053-dbdaa90a6471Drug Facts
67510-0066-12020-07-22C16284748780-1ab0e2407-27c4-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0066-1Antibiotic28 g in 1 TUBEOINTMENT284
67510-0066-1Antibiotic1 in 1 BOXOINTMENT14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693ANTIBIOTIC (NEOMYCIN SULFATE ) OINTMENT [KAREWAY PRODUCT, INC.]2
NEOMYCINACTIVE MOIETYI16QD7X297ANTIBIOTIC (NEOMYCIN SULFATE ) OINTMENT [KAREWAY PRODUCT, INC.]2
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NANTIBIOTIC (NEOMYCIN SULFATE ) OINTMENT [KAREWAY PRODUCT, INC.]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SANTIBIOTIC (NEOMYCIN SULFATE ) OINTMENT [KAREWAY PRODUCT, INC.]2
LANOLININACTIVE INGREDIENT7EV65EAW6HANTIBIOTIC (NEOMYCIN SULFATE ) OINTMENT [KAREWAY PRODUCT, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANTIBIOTIC (NEOMYCIN SULFATE ) OINTMENT [KAREWAY PRODUCT, INC.]2
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEANTIBIOTIC (NEOMYCIN SULFATE ) OINTMENT [KAREWAY PRODUCT, INC.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UANTIBIOTIC (NEOMYCIN SULFATE ) OINTMENT [KAREWAY PRODUCT, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHANTIBIOTIC (NEOMYCIN SULFATE ) OINTMENT [KAREWAY PRODUCT, INC.]2
SQUALANEINACTIVE INGREDIENTGW89575KF9ANTIBIOTIC (NEOMYCIN SULFATE ) OINTMENT [KAREWAY PRODUCT, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0066ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [KAREWAY PRODUCT, INC.]4Legacy NDC, 2 package rows20180323_474fab45-bfca-47d0-ba54-971d764ff951.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311928neomycin 0.35 % Topical OintmentPSN474fab45-bfca-47d0-ba54-971d764ff9514
311928neomycin 0.0035 MG/MG Topical OintmentSCD474fab45-bfca-47d0-ba54-971d764ff9514
311928neomycin (as neomycin sulfate 5 MG per 1 GM) 3.5 MG per 1 GM Topical OintmentSY474fab45-bfca-47d0-ba54-971d764ff9514
311928neomycin 0.35 % Topical OintmentSY474fab45-bfca-47d0-ba54-971d764ff9514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67510-0066-16751000660128 g in 1 TUBE28 gHistorical