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
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
2026-12-31

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
61010-6700-22024-02-1361010-6700, Single Antibiotic with Neomycin, ointment
61010-6700-32024-02-1361010-6700, Single Antibiotic with Neomycin, ointment
61010-6700-22024-01-3061010-6700, Single Antibiotic with Neomycin, ointment
61010-6700-32024-01-3061010-6700, 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

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 8 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GASCO ANTIBACTERIALBENZALKONIUM CHLORIDEGASCO INDUSTRIAL CORP411ffefe-16e5-a2e0-e063-6394a90a0cd42025-10-14WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC4124e9e2-397f-8921-e063-6394a90a5ffe2025-10-14WarningsExact identifier
application number: M004
AntibioticNEOMYCIN SULFATETotal Resources International0725364b-b243-4891-af2f-a6049366d0382025-10-10WarningsExact identifier
application number: M004
MediChoice BacitracinBACITRACINO&M HALYARD, INC.78079b94-c6fc-4529-aaad-8186924ecba52025-10-09WarningsExact identifier
application number: M004
MediChoice Triple AntibioticBACITRACINO&M HALYARD, INC.8369f399-6f64-4441-be72-1f16c7306c0a2025-10-09WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEMedline Industries, LP301ebb9a-033b-4f04-99ff-571e921924ca2025-10-09WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINCMedline Industries, LPf8282204-f9b9-486f-b18b-dc5ba85cce102025-10-09WarningsExact identifier
application number: M004
TheraCare Triple Antibiotic Pain ReliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINEVeridian Healthcarefaf73908-324f-27f5-e053-6394a90aa06e2025-10-02WarningsExact identifier
application number: M004
Viaderma Care First AidBACITRACIN ZINCViaDerma Distribution, Inc.dabb7ce8-3284-4dfc-bc6e-38a691be43c12025-10-02WarningsExact identifier
application number: M004
Double AntibioticBACITRACIN ZINC POLYMYXIN B SULFATEEncube Ethicals, Inc.8f00b059-6729-4fae-8e8c-e14fe8838c592025-09-30WarningsExact identifier
application number: M004
Xpect Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECintas Corporation39355db3-24d7-485f-9ce0-f0e466e965932025-09-26WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE PRAMOXINE HCLEncube Ethicals, Inc.dfea6b2e-cd76-439d-a3da-64e2d87171632025-09-25WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEEncube Ethicals, Inc.2e985ad0-aa50-4c6b-b0af-1d61489a9fda2025-09-25WarningsExact identifier
application number: M004
Medi-First Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationf2f0a1da-3e33-3c1a-e053-2a95a90a12b12025-09-09WarningsExact identifier
application number: M004
Ecolab Triple AntibioticBACITRACIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEcolabs Food Safety Specialties, Inc.4aef8f98-db76-07f2-e054-00144ff8d46c2025-09-09WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationd265f094-e654-4c68-9215-b5d061af885d2025-09-08WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationd7c1a10e-c38d-4ae8-9a27-c07c2208ca842025-09-08WarningsExact identifier
application number: M004
Thompson Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEThompsonf883c4cb-c32c-76e3-e053-6294a90aa4fc2025-09-08WarningsExact identifier
application number: M004
Thompson Triple AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATEThompsonde9489de-e677-2bd3-e053-2a95a90acfb42025-09-08WarningsExact identifier
application number: M004
BACITRACIN ZINCFIRST AID ANTIBIOTICEncube Ethicals, Inc.613cbed4-9790-4e6b-a61b-b7b7a8ee59c92025-09-04WarningsExact 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