FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
69396-131
11-digit product format
693960131
Labeler code
69396
Product ID
69396-131_2a9212c8-b14c-b537-e063-6394a90a5119
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
TRIFECTA PHARMACEUTICALS USA LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-08
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
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
69396-131-01Triple Antibiotic1 in 1 BOXOINTMENT12
69396-131-01Triple Antibiotic28.3 g in 1 TUBEOINTMENT28.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-131TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]2Current NDC, 2 package rows20250101_0c017b10-29b6-e30f-e063-6294a90a8a3c.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 OintmentPSN0c017b10-29b6-e30f-e063-6294a90a8a3c2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD0c017b10-29b6-e30f-e063-6294a90a8a3c2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY0c017b10-29b6-e30f-e063-6294a90a8a3c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-131-01693960131011 TUBE in 1 BOX (69396-131-01) / 28.3 g in 1 TUBE1 tube2023-12-08NoNoCurrent