FDA.reportPublic FDA data

PENIMIXCINA

Product NDC
69729-615
11-digit product format
697290615
Labeler code
69729
Product ID
69729-615_18ae5c8b-2507-fac3-e063-6394a90a6072
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN, NEOMYCIN SULFATE, POLYMIXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
OPMX LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-05
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
500; 5; 5000; 10 [iU]/g; mg/g; [iU]/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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PENIMIXCINA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/g
NEOMYCIN SULFATE5 mg/g
POLYMYXIN B SULFATE5000 [iU]/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4, 88AYB867L5
Rxcui2055751

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
69729-615-052024-05-19C16284748780-19d75b9d0-643c-f424-e053-dadaa90a57cePenimixcina - First Aid Ointment
69729-615-052024-01-30C16284748780-19d75b9d0-643c-f424-e053-dadaa90a57cePenimixcina - First Aid Ointment
69729-615-052022-10-19C16284748780-19d75b9d0-643c-f424-e053-dadaa90a57cePenimixcina - First Aid Ointment
69729-615-052020-01-31C16284748780-19d75b9d0-643c-f424-e053-dadaa90a57cePenimixcina - First Aid Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-615-01PENIMIXCINA14 g in 1 TUBEOINTMENT145
69729-615-05PENIMIXCINA1 in 1 BOXOINTMENT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-615PENIMIXCINA (BACITRACIN, NEOMYCIN SULFATE, POLYMIXIN B SULFATE, PRAMOXINE HYDROCHLORIDE) OINTMENT [OPMX LLC]5Current NDC, Legacy NDC, 2 package rows20240521_92bcbc02-9683-4117-af2b-6d4687796f1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2055751bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT / pramoxine HCl 10 MG per GM Topical OintmentPSN92bcbc02-9683-4117-af2b-6d4687796f1f5
2055751bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical OintmentSCD92bcbc02-9683-4117-af2b-6d4687796f1f5
2055751bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT / pramoxine HCl 10 MG per GM Topical OintmentSY92bcbc02-9683-4117-af2b-6d4687796f1f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69729-615-016972906150114 g in 1 TUBE14 gHistorical
69729-615-05697290615051 TUBE in 1 BOX (69729-615-05) / 14 g in 1 TUBE (69729-615-01) 1 tube2018-09-050000-00-00NoNoCurrent