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 9 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antibiotic Maximum StrengthBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWalgreens9a092f24-65b2-4b57-8103-265ea3e033112025-09-02WarningsExact identifier
application number: M004
AerosootheTRIPLE ANTIBIOTIC OINTMENTAero Healthcare US LLC2287a31c-750c-728d-e054-00144ff88e882025-08-29WarningsExact identifier
application number: M004
Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEChain Drug Marketing Association Inc.3d4b3d73-171a-bc6a-e063-6394a90a69c12025-08-26WarningsExact identifier
application number: M004
Dual Action CreamNEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCLTrifecta Pharmaceutical USA LLCb84015ae-9c76-b1d7-e053-2a95a90a2cc82025-08-23WarningsExact identifier
application number: M004
Natureplex Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDENatureplex LLCf0af8829-72fb-46b1-9328-6f4920710bb12025-08-15WarningsExact identifier
application number: M004
PROHEAL TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.6c61d88e-4ced-4468-8f99-91652f7a03e42025-08-13WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEJ&A Digital Inc.9f006f16-083d-4e95-aec2-6ef83405f3932025-08-07WarningsExact identifier
application number: M004
Vitacilina First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETaisho Pharmaceutical California Inc.93fb9e05-f78c-4d37-b6f1-926cbcb2e7a72025-08-07WarningsExact identifier
application number: M004
SurviveX Triple AntibioticTRIPLE ANTIBIOTIC OINTMENTNantong Health & Beyond Hygienic Products Inc.3bd25bb6-6486-8a0a-e063-6394a90a085c2025-08-07WarningsExact identifier
application number: M004
Thera Plus Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFOURSTAR GROUP USA, INC.09e8bdb7-dc14-4f28-8306-c0e2bf73f0812025-07-31WarningsExact identifier
application number: M004
BacitracinBACITRACINBryant Ranch Prepack0c081802-429f-468f-9650-293cb7a1ad342025-07-29WarningsExact identifier
application number: M004
health and .beyond Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0070ea5f-434d-53a7-e063-6294a90abf182025-07-27WarningsExact identifier
application number: M004
health and beyond TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.13cbe416-a146-447d-be36-8b3af9b3c8952025-07-27WarningsExact identifier
application number: M004
AOSI HEALTHCARE TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.70c53369-7cf6-4352-a19f-c85a55c5a4bd2025-07-27WarningsExact identifier
application number: M004
Pomada de SulfaNEOMYCIN SULFATEMenper Distributors, Inc.216f4d22-e5e8-46c8-a4ef-8d1532792b562025-07-22WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATESTRATEGIC SOURCING SERVICES LLC1bda9c30-8fc8-4814-b211-94550672b22f2025-07-21WarningsExact identifier
application number: M004
Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC6a61c900-2dfc-4c07-8ae5-32ffbd89d2b62025-07-21WarningsExact identifier
application number: M004
FifthPulse Bacitracin Zinc 1ozBACITRACIN ZINCFront Pharmaceutical PLC39f994d4-5f41-fb34-e063-6294a90a45ea2025-07-15WarningsExact identifier
application number: M004
FifthPulse Bacitracin Zinc 4ozBACITRACIN ZINCFront Pharmaceutical PLC39fa0e5f-b794-e1e3-e063-6394a90a4ce32025-07-15WarningsExact identifier
application number: M004
FifthPulse Hydrocortisone 1ozHYDROCORTISONEFront Pharmaceutical PLC39fae2a4-902e-3c88-e063-6394a90acbd52025-07-15WarningsExact 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