FDA.reportPublic FDA data

Triple antibiotic and pain relief

Product NDC
79481-0016
11-digit product format
794810016
Labeler code
79481
Product ID
79481-0016_f202600b-ca3a-f1c9-e053-2a95a90ab17e
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin,Neomycin,Polymyxin, Pramoxine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Meijer
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-06-25
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500 [USP'U]/g; mg/g; [USP'U]/g; mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79481-0016-12025-01-30C16284748780-12cef2736-a431-d83d-e063-dadaa90ab31fMeijer Triple Antibiotic + Pain Relief Ointment
79481-0016-22025-01-30C16284748780-12cef2736-a431-d83d-e063-dadaa90ab31fMeijer Triple Antibiotic + Pain Relief Ointment
79481-0016-52025-01-30C16284748780-12cef2736-a431-d83d-e063-dadaa90ab31fMeijer Triple Antibiotic + Pain Relief Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0016-1Triple antibiotic and pain relief1 in 1 BOXOINTMENT16
79481-0016-1Triple antibiotic and pain relief28 g in 1 TUBEOINTMENT286
79481-0016-2Triple antibiotic and pain relief1 in 1 BOXOINTMENT16
79481-0016-2Triple antibiotic and pain relief2 in 1 PACKAGE, COMBINATIONOINTMENT26
79481-0016-5Triple antibiotic and pain relief14 g in 1 TUBEOINTMENT146
79481-0016-5Triple antibiotic and pain relief1 in 1 BOXOINTMENT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0016TRIPLE ANTIBIOTIC AND PAIN RELIEF (BACITRACIN,NEOMYCIN,POLYMYXIN, PRAMOXINE) OINTMENT [MEIJER]6Legacy NDC, 6 package rows20230112_c59a94ef-63d7-50d7-e053-2995a90ae125.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical OintmentPSNc59a94ef-63d7-50d7-e053-2995a90ae1256
1359350bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCDc59a94ef-63d7-50d7-e053-2995a90ae1256
1359350bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSYc59a94ef-63d7-50d7-e053-2995a90ae1256

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79481-0016-1794810016011 TUBE in 1 BOX (79481-0016-1) > 28 g in 1 TUBE1 tube2021-06-250000-00-00NoNoCurrent
79481-0016-2794810016021 PACKAGE, COMBINATION in 1 BOX (79481-0016-2) > 2 TUBE in 1 PACKAGE, COMBINATION > 28 g in 1 TUBE2021-06-250000-00-00NoNoCurrent
79481-0016-5794810016051 TUBE in 1 BOX (79481-0016-5) > 14 g in 1 TUBE1 tube2021-06-250000-00-00NoNoCurrent