FDA.reportPublic FDA data

UEC Medical First Aid Antibiotic

Product NDC
65923-391
11-digit product format
659230391
Labeler code
65923
Product ID
65923-391_693158fb-ff9d-d911-e053-2a91aa0afaf5
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin zinc, neomycin sulfate, and polymyxin b sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
United Exchange Corp.
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-04-04
Marketing end
0000-00-00
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC
Active strength
4 mg/g; [iU]/g; [iU]/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65923-391IInactivated by FDA2026-07-31
excluded packagepackage65923-39165923-391-20IInactivated by FDA2026-07-31
excluded packagepackage65923-39165923-391-21IInactivated by FDA2026-07-31
excluded packagepackage65923-39165923-391-44IInactivated by FDA2026-07-31
excluded packagepackage65923-39165923-391-45IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Water-Jel 3-in-1 AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATEWater-Jel Technologiesd5fcaffd-af38-4285-a79c-6df7424c76fa2017-11-16WarningsExact identifier
CVS Triple AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN BCVS Pharmacy454bfeed-f58f-003a-e054-00144ff8d46c2017-01-04WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Do not use in the eyes or over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor Ask a doctor before use if you have a deep or puncture wounds, animal bites, or serious burns Stop use and ask a doctor if Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65923-391-202024-01-30C16284748780-11030e365-6e8c-111a-e063-dadaa90a10e2UEC Medical Triple Antibiotic Ointment 0.5g NBE Neosporin 20 and 144 ct- 10391 and 10395 (2018)
65923-391-212024-01-30C16284748780-11030e365-6e8c-111a-e063-dadaa90a10e2UEC Medical Triple Antibiotic Ointment 0.5g NBE Neosporin 20 and 144 ct- 10391 and 10395 (2018)
65923-391-442024-01-30C16284748780-11030e365-6e8c-111a-e063-dadaa90a10e2UEC Medical Triple Antibiotic Ointment 0.5g NBE Neosporin 20 and 144 ct- 10391 and 10395 (2018)
65923-391-452024-01-30C16284748780-11030e365-6e8c-111a-e063-dadaa90a10e2UEC Medical Triple Antibiotic Ointment 0.5g NBE Neosporin 20 and 144 ct- 10391 and 10395 (2018)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-391-20UEC Medical First Aid Antibiotic20 in 1 BOXOINTMENT202
65923-391-20UEC Medical First Aid Antibiotic0.5 g in 1 PACKETOINTMENT0.52
65923-391-21UEC Medical First Aid Antibiotic0.9 g in 1 PACKETOINTMENT0.92
65923-391-21UEC Medical First Aid Antibiotic20 in 1 BOXOINTMENT202
65923-391-44UEC Medical First Aid Antibiotic144 in 1 BOXOINTMENT1442
65923-391-44UEC Medical First Aid Antibiotic0.5 g in 1 PACKETOINTMENT0.52
65923-391-45UEC Medical First Aid Antibiotic0.9 g in 1 PACKETOINTMENT0.92
65923-391-45UEC Medical First Aid Antibiotic144 in 1 BOXOINTMENT1442

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-391UEC MEDICAL FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [UNITED EXCHANGE CORP.]2Legacy NDC, 8 package rows20180406_69237c1b-4a71-8f93-e053-2991aa0a1b02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN69237c1b-4a71-8f93-e053-2991aa0a1b022
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD69237c1b-4a71-8f93-e053-2991aa0a1b022
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY69237c1b-4a71-8f93-e053-2991aa0a1b022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65923-391-206592303912020 PACKET in 1 BOX (65923-391-20) > .5 g in 1 PACKET20 packet2016-04-040000-00-00NoNoCurrent
65923-391-216592303912120 PACKET in 1 BOX (65923-391-21) > .9 g in 1 PACKET20 packet2016-04-040000-00-00NoNoCurrent
65923-391-4465923039144144 PACKET in 1 BOX (65923-391-44) > .5 g in 1 PACKET144 packet2016-04-040000-00-00NoNoCurrent
65923-391-4565923039145144 PACKET in 1 BOX (65923-391-45) > .9 g in 1 PACKET144 packet2016-04-040000-00-00NoNoCurrent