FDA.reportPublic FDA data

Leader Triple antibiotic

Product NDC
70000-0687
11-digit product format
700000687
Labeler code
70000
Product ID
70000-0687_2175e00a-bf86-3377-e063-6394a90a916f
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin,Neomycin,Polymxin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cardinal Health 110 dba LEADER
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-15
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/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
Leader Triple antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 057Y626693, 19371312D4
Rxcui204602

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0687-1Leader Triple antibiotic28 g in 1 TUBEOINTMENT281
70000-0687-1Leader Triple antibiotic1 in 1 BOXOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0687LEADER TRIPLE ANTIBIOTIC (BACITRACIN,NEOMYCIN,POLYMXIN) OINTMENT [CARDINAL HEALTH 110 DBA LEADER]1Current NDC, 2 package rows20240907_2175e00a-bf85-3377-e063-6394a90a916f.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 OintmentPSN2175e00a-bf85-3377-e063-6394a90a916f1
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD2175e00a-bf85-3377-e063-6394a90a916f1
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY2175e00a-bf85-3377-e063-6394a90a916f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0687-1700000687011 TUBE in 1 BOX (70000-0687-1) / 28 g in 1 TUBE1 tube2024-08-15NoNoHistorical