FDA.reportPublic FDA data

Major Triple Antibiotic

Product NDC
0904-8805
11-digit product format
009048805
Labeler code
0904
Product ID
0904-8805_21dbd44e-7fb5-874e-e063-6394a90a4e8b
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin, Polymyxin B Sulfat
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Major Pharmaceuticals
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-20
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
Major 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
0904-8805-31Major Triple Antibiotic28 g in 1 TUBEOINTMENT285
0904-8805-31Major Triple Antibiotic1 in 1 BOXOINTMENT15
0904-8805-67Major Triple Antibiotic144 in 1 CARTONOINTMENT1445
0904-8805-67Major Triple Antibiotic0.9 g in 1 PACKETOINTMENT0.95

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-8805-31GM - Gram0904-88051ddaba87-ed34-4e7e-a729-99f3a70b30d412024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-8805MAJOR TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B SULFAT) OINTMENT [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 4 package rows20240918_a6cc3fbc-6302-4033-e053-2a95a90a19f0.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 OintmentPSNa6cc3fbc-6302-4033-e053-2a95a90a19f05
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDa6cc3fbc-6302-4033-e053-2a95a90a19f05
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYa6cc3fbc-6302-4033-e053-2a95a90a19f05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-8805-31009048805311 TUBE in 1 BOX (0904-8805-31) / 28 g in 1 TUBE1 tube2024-08-20NoNoHistorical
0904-8805-6700904880567144 PACKET in 1 CARTON (0904-8805-67) / .9 g in 1 PACKET144 packet2020-05-290000-00-00NoNoCurrent