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
2027-12-31
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
Single Antibiotic with Neomycin
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
057Y626693Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311928Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e989cf7e-f3d1-42d2-af45-fc80095b97cbAvailable on FDA.report

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#

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

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 20 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Triple AntibioticFIRST AID TRIPLE ANTIBIOTICCardinal Health 110,Inc.844cd9a1-b68e-47d8-a5eb-c9e880ba019e2024-01-18WarningsExact identifier
application number: M004
Multi-Action Antibiotic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE OINTMENTTarget Corporation8fecff32-bd67-4351-90f7-0c28cb335ea32024-01-18WarningsExact identifier
application number: M004
Leader Poly BacitracinFIRST AID ANTIBIOTICCardinal Health 110, Inc.442e11aa-7d14-44f9-bf14-446018f1de0d2024-01-18WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporation7b16cb9b-5847-4360-9974-2118f4a2c70f2024-01-17WarningsExact identifier
application number: M004
Green Guard Triple AntibioticBACITRACIN ZIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationbd456e2f-e6d7-d2ad-e053-2995a90a5c122024-01-17WarningsExact identifier
application number: M004
Medi-First Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationbd432abc-fefb-1b4b-e053-2995a90acb182024-01-17WarningsExact identifier
application number: M004
Crane Safety Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECrane Safety LLC96dbc282-4b3f-aaf3-e053-2995a90a56942024-01-17WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATETarget Corporation10c4a1b5-bb91-48da-b0ae-303e4adf793a2024-01-17WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINCTarget Corporation6020956d-2f58-4be8-97da-3f6b7e0f34aa2024-01-17WarningsExact identifier
application number: M004
Triple Antibiotic and Pain ReliefTRIPLE ANTIBIOTICTarget Corporation8fda7b8a-72f3-4b92-a229-ac5be0e3b3eb2024-01-17WarningsExact identifier
application number: M004
Travel Savvy First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEBellegrove Medical Supply, Inc.69fa1c9d-5e6d-4593-e053-2a91aa0a76902024-01-16WarningsExact identifier
application number: M004
American Safety First Aid AntispeticISOPROPYL ALCOHOLOrazen Incea302ba4-a63d-e713-e053-2995a90a3fc42024-01-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESled Distribution, LLCe7398df8-8e23-5439-e053-2a95a90ac3aa2024-01-15WarningsExact identifier
application number: M004
ER Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVER READY FIRST AID20f97e1c-584f-4844-afd8-8641ffe2f4662024-01-11WarningsExact identifier
application number: M004
Lightning X Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0e66af91-e0b4-827f-e063-6294a90a98472024-01-07WarningsExact identifier
application number: M004
triple antibiotic 01BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECosmuses Cosmetics (Ningbo) Co., Ltd.0e1b23f3-fa1e-f42b-e063-6394a90a3bec2024-01-04WarningsExact identifier
application number: M004
Triple Antibiotic Ointment, Circle KTRIPLE ANTIBIOTICLil' Drug Store products, Inc.0d98477b-aa33-ebb7-e063-6294a90a597f2024-01-03WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLCd9f2702c-a514-cb69-e053-2a95a90a29a92024-01-02WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.Geri-Care Pharmaceuticals, Corpef309620-1cf9-d007-e053-2995a90ad46f2024-01-02WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCGeri-Care Pharmaceuticals, Corp.eec90f72-fd13-05c9-e053-2995a90a642a2024-01-02WarningsExact identifier
application number: M004

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