FDA.reportPublic FDA data

Antibiotic

Product NDC
55550-730
11-digit product format
555500730
Labeler code
55550
Product ID
55550-730_5cf31e3a-83a6-48dd-9396-dcc812cd8cbf
Type
HUMAN OTC DRUG
Nonproprietary name
neomycin sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Total Resources International
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-07
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55550-730-21367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55550-730-21557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55550-730-218af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55550-730-21834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55550-730-211332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55550-730-21fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55550-730-2186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55550-730-21bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55550-730-218dfbde2a14a4…c9ff85d89658…

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
Antibiotic
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
0725364b-b243-4891-af2f-a6049366d038Available 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#

Effective, Related label table
EffectiveRelated label
2024-10-030725364b-b243-4891-af2f-a6049366d038
2024-10-030725364b-b243-4891-af2f-a6049366d038
2024-01-300725364b-b243-4891-af2f-a6049366d038
2024-01-300725364b-b243-4891-af2f-a6049366d038
2022-12-190725364b-b243-4891-af2f-a6049366d038
2022-12-190725364b-b243-4891-af2f-a6049366d038
2021-01-290725364b-b243-4891-af2f-a6049366d038
2021-01-290725364b-b243-4891-af2f-a6049366d038

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55550-730-21Antibiotic0.9 g in 1 POUCHOINTMENT0.94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55550-730ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [TOTAL RESOURCES INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20241004_0725364b-b243-4891-af2f-a6049366d038.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 13 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Balma Septic Antiseptic Hand WashBENZALKONIUM CHLORIDERochester Midland Corporation1b8e0a27-dcdd-4d07-b0f2-55cf74a9b5282025-01-10WarningsExact identifier
application number: M004
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380CHLOROXYLENOLABC Compounding Co., Inc.efa3938f-64de-77ba-e053-2a95a90ac8402025-01-10WarningsExact identifier
application number: M004
BacitracinBACITRACINA-S Medication Solutions64aa660d-2d69-48e8-bd0d-4876815d89ff2025-01-08WarningsExact identifier
application number: M004
BacitracinBACITRACINWater-Jel Technologies412928a1-3708-4fa8-99c5-aaa2b079cf6e2025-01-06WarningsExact identifier
application number: M004
AVON HeXashield Triple Antibiotic with Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLTai Guk Pharm. Co., Ltd.8e0cb861-d8aa-1f71-e053-2a95a90aaa882025-01-01WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA LLC087694c2-4b1b-e293-e063-6294a90a961f2024-12-31WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETRIFECTA PHARMACEUTICALS USA LLC0c017b10-29b6-e30f-e063-6294a90a8a3c2024-12-31WarningsExact identifier
application number: M004
Triple Antibiotic and Pain ReliefBACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC0bf08cf6-be3f-f9aa-e063-6294a90a43932024-12-31WarningsExact identifier
application number: M004
Single Antibiotic with BacitracinBACITRACIN ZINCRandob Labs Ltd.2a807f1b-986f-a9ea-e063-6394a90aed252024-12-30WarningsExact identifier
application number: M004
TripleantibioticapainscaritchFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCLTrifecta Pharmaceutical USA LLC935106c6-8a9e-07fa-e053-2a95a90a24842024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.TRIFECTA PHARMACEUTICALS USA LLC00c52a31-9bfa-a8bf-e063-6294a90ac4d72024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATETrifecta Pharmaceuticals Usa Llcd04b397c-1608-4fd9-be28-ef7285d6a9962024-12-20WarningsExact identifier
application number: M004
TripleantibioticointmentandpainreliefFAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINETrifecta Pharmaceutical USA LLC91575333-5268-5d8f-e053-2a95a90a7a892024-12-20WarningsExact identifier
application number: M004
Premier Value Max Strength Antibiotic plus pain reliefPREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLPharmacy Value Alliance LLC9767821e-054b-3bd3-e053-2a95a90a4b0e2024-12-20WarningsExact identifier
application number: M004
Premier Value Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPremier Value Alliance LLC.ab843664-a1e0-6716-e053-2995a90a20632024-12-20WarningsExact identifier
application number: M004
Premier Value Bacitracin ZincBACITRACIN ZINCPharmacy Value Alliance LLC99d789be-aa85-0917-e053-2a95a90acd132024-12-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEPremier Value Alliance LLC.ab863d90-1a8f-3c1f-e053-2a95a90aa0a72024-12-20WarningsExact identifier
application number: M004
Family Wellness First Aid AntibioticFAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATETrifecta Pharmaceuticals USA, LLC9157681a-3ed1-096e-e053-2a95a90a05e32024-12-18WarningsExact identifier
application number: M004
Family Wellness OriginalFAMILY WELLNESS BACITRACIN, NEOMYCIN, POLYMYXIN BTrifecta Pharmaceuticals USA LLC.915759af-0d4f-6a87-e053-2a95a90acbd62024-12-18WarningsExact identifier
application number: M004
Family Wellness Pain Scar ItchBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLTrifecta Pharmaceutical USA LLC9e507ec5-310d-3a21-e053-2a95a90a15a62024-12-18WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311928neomycin 0.35 % Topical OintmentPSN0725364b-b243-4891-af2f-a6049366d0384
311928neomycin 0.0035 MG/MG Topical OintmentSCD0725364b-b243-4891-af2f-a6049366d0384
311928neomycin (as neomycin sulfate 5 MG per 1 GM) 3.5 MG per 1 GM Topical OintmentSY0725364b-b243-4891-af2f-a6049366d0384
311928neomycin 0.35 % Topical OintmentSY0725364b-b243-4891-af2f-a6049366d0384

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55550-730-2155550073021.9 g in 1 POUCH (55550-730-21) 2019-10-070000-00-00NoNoCurrent