FDA.reportPublic FDA data

POMADA SULFA FIRST AID ANTIBIOTIC

Product NDC
48201-104
11-digit product format
482010104
Labeler code
48201
Product ID
48201-104_42407f73-c1f3-9f81-e063-6294a90a502d
Type
HUMAN OTC DRUG
Nonproprietary name
NEOMYCIN SULFATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
GRANDALL DISTRIBUTING, LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-18
Substance
NEOMYCIN SULFATE
Active strength
.5 g/100g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
POMADA SULFA FIRST AID ANTIBIOTIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE.5 g/100g

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
1544556Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d8e1fca-6864-7c08-e063-6394a90a08b6Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48201-104-40POMADA SULFA FIRST AID ANTIBIOTIC40 g in 1 JAROINTMENT402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48201-104POMADA SULFA FIRST AID ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [GRANDALL DISTRIBUTING, LLC]1Current NDC, 1 package rows20240720_1d8e1fca-6864-7c08-e063-6394a90a08b6.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 14 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Antibiotic plus Burn ReliefBACITRACINZINC,NEOMYCINSULFATE,POLYMXINBSULFATE,PRAMOXINEHCITrifecta Pharmaceuticals USA LLC048871e2-c917-292d-e063-6394a90af1302024-12-18WarningsExact identifier
application number: M004
TheraCare Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEVeridian Healthcare0c3fc798-9a97-5316-e063-6394a90a68302024-12-18WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCRugby Laboratoriesac3c9897-c812-1360-e053-2a95a90ad5912024-12-17WarningsExact identifier
application number: M004
Major BacitracinBACITRACIN ZINCMajor Pharmaceuticalsa23ce772-7078-0a4b-e053-2995a90aff0d2024-12-17WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLCeea0d90c-914b-2624-e053-2a95a90a34c92024-12-13WarningsExact identifier
application number: M004
OP First Aid Series TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.cadebf07-dd48-4855-8296-7a91e28d71232024-12-05WarningsExact identifier
application number: M004
triple antibiotic and pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDECVS Pharmacyf0864d78-23e6-4e6c-bc67-7ba3e6dd862c2024-12-03WarningsExact identifier
application number: M004
triple antibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEPublix Super Markets Inc330c7b7a-d0d1-42dc-b8f7-9c96aeaf69f92024-11-25WarningsExact identifier
application number: M004
WinCo Maximum Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDEWinCo Foods, LLC01b03c7e-6c4e-43aa-8480-aff1c2688f7f2024-11-21WarningsExact identifier
application number: M004
WinCo Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEWinCo Foods, LLCe364b623-6e20-4894-8d4c-5c739be78f862024-11-21WarningsExact identifier
application number: M004
Winco Bacitracin ZincBACITRACIN ZINCWinCo Foods, LLCdcdf647f-fa32-4b72-b714-a77e8e3323582024-11-21WarningsExact identifier
application number: M004
Walgreens Multi-Antibiotic with Pain Relief CreamPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDEWalgreens Companyf4feccc3-ac25-4d8a-9b68-9a24f755524a2024-11-20WarningsExact identifier
application number: M004
Walgreens Kids Multi-Antibiotic with Pain Relief CreamPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDEWalgreens Companyfbc364d7-d8b8-43f5-99cc-290438f3982b2024-11-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAcme United Corporationf9a48f73-aa12-cf68-e053-6294a90a8e532024-11-19WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEAcme United Corporatione55cbf7e-c955-7f1a-e053-2a95a90a3f282024-11-19WarningsExact identifier
application number: M004
First Aid Only Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAcme United Corporationf4eba34c-ce31-3004-e053-2995a90a245b2024-11-19WarningsExact identifier
application number: M004
First Aid Only Neomycin AntibioticNEOMYCIN SULFATEAcme United Corporationc651e98e-aabe-de46-e053-2a95a90a63072024-11-19WarningsExact identifier
application number: M004
Neosporin OriginalBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEKenvue Brands LLCf07d3bca-4312-46ed-b0c4-f886c01bd0952024-11-14WarningsExact identifier
application number: M004
Polysporin First Aid AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEKenvue Brands LLCe0fcf83e-a374-4fc0-a629-8730330543922024-11-14WarningsExact identifier
application number: M004
Neosporin Pain Itch ScarBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC55392c48-b5d8-44cd-8c10-6d86683498482024-11-13WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544556neomycin sulfate 0.5 % Topical OintmentPSN1d8e1fca-6864-7c08-e063-6394a90a08b62
1544556neomycin sulfate 0.005 MG/MG Topical OintmentSCD1d8e1fca-6864-7c08-e063-6394a90a08b62
1544556neomycin sulfate 0.5 % Topical OintmentSY1d8e1fca-6864-7c08-e063-6394a90a08b62
1544556neomycin sulfate 5 MG/GM Topical OintmentSY1d8e1fca-6864-7c08-e063-6394a90a08b62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48201-104-404820101044040 g in 1 JAR (48201-104-40) 40 g2024-07-18NoNoCurrent