FDA.reportPublic FDA data

Single Antibiotic with Neomycin

Product NDC
61010-6700
11-digit product format
610106700
Labeler code
61010
Product ID
61010-6700_10dff217-0d5f-cc47-e063-6294a90a632d
Type
HUMAN OTC DRUG
Nonproprietary name
neomycin sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Safetec of America
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-11-13
Substance
NEOMYCIN SULFATE
Active strength
3.5 mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Single Antibiotic with Neomycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE3.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii057Y626693
Rxcui311928

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
61010-6700-22024-02-13C16284748780-11030e365-670f-111a-e063-dadaa90a10e261010-6700, Single Antibiotic with Neomycin, ointment
61010-6700-32024-02-13C16284748780-11030e365-670f-111a-e063-dadaa90a10e261010-6700, Single Antibiotic with Neomycin, ointment
61010-6700-22024-01-30C16284748780-11030e365-670f-111a-e063-dadaa90a10e261010-6700, Single Antibiotic with Neomycin, ointment
61010-6700-32024-01-30C16284748780-11030e365-670f-111a-e063-dadaa90a10e261010-6700, Single Antibiotic with Neomycin, ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-6700-1Single Antibiotic with Neomycin0.9 g in 1 POUCHOINTMENT0.94
61010-6700-2Single Antibiotic with Neomycin144 in 1 BOXOINTMENT1444
61010-6700-3Single Antibiotic with Neomycin25 in 1 BOXOINTMENT254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-6700SINGLE ANTIBIOTIC WITH NEOMYCIN (NEOMYCIN SULFATE) OINTMENT [SAFETEC OF AMERICA]4Current NDC, Legacy NDC, 3 package rows20240214_e989cf7e-f3d1-42d2-af45-fc80095b97cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311928neomycin 0.35 % Topical OintmentPSNe989cf7e-f3d1-42d2-af45-fc80095b97cb4
311928neomycin 0.0035 MG/MG Topical OintmentSCDe989cf7e-f3d1-42d2-af45-fc80095b97cb4
311928neomycin (as neomycin sulfate 5 MG per 1 GM) 3.5 MG per 1 GM Topical OintmentSYe989cf7e-f3d1-42d2-af45-fc80095b97cb4
311928neomycin 0.35 % Topical OintmentSYe989cf7e-f3d1-42d2-af45-fc80095b97cb4
311928neomycin 0.35 % Topical OintmentPSNc651e98e-aabe-de46-e053-2a95a90a63073
311928neomycin 0.0035 MG/MG Topical OintmentSCDc651e98e-aabe-de46-e053-2a95a90a63073
311928neomycin (as neomycin sulfate 5 MG per 1 GM) 3.5 MG per 1 GM Topical OintmentSYc651e98e-aabe-de46-e053-2a95a90a63073
311928neomycin 0.35 % Topical OintmentSYc651e98e-aabe-de46-e053-2a95a90a63073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-6700-1610106700010.9 g in 1 POUCH0.9 gHistorical
61010-6700-261010670002144 POUCH in 1 BOX (61010-6700-2) / .9 g in 1 POUCH (61010-6700-1) 144 pouch2008-11-130000-00-00NoNoCurrent
61010-6700-36101067000325 POUCH in 1 BOX (61010-6700-3) / .9 g in 1 POUCH (61010-6700-1) 25 pouch2008-11-130000-00-00NoNoCurrent