FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
69396-015
11-digit product format
693960015
Labeler code
69396
Product ID
69396-015_29b3cf7a-7949-6a29-e063-6294a90ac3d7
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
2016-03-18
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
69396-015-05Triple Antibiotic1 in 1 BOXOINTMENT17
69396-015-05Triple Antibiotic15 g in 1 TUBEOINTMENT157
69396-015-20Triple Antibiotic1 in 1 BOXOINTMENT17
69396-015-20Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-015-05GM - Gram69396-0151389f37c-e1e6-4a15-9576-ba154997dac612023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-015TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]7Current NDC, Legacy NDC, 4 package rows20241222_d04b397c-1608-4fd9-be28-ef7285d6a996.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 OintmentPSNd04b397c-1608-4fd9-be28-ef7285d6a9967
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDd04b397c-1608-4fd9-be28-ef7285d6a9967
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYd04b397c-1608-4fd9-be28-ef7285d6a9967

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-015-05693960015051 TUBE in 1 BOX (69396-015-05) / 15 g in 1 TUBE1 tube2016-03-180000-00-00NoNoCurrent
69396-015-20693960015201 TUBE in 1 BOX (69396-015-20) / 28.4 g in 1 TUBE1 tube2016-03-180000-00-00NoNoCurrent