FDA.reportPublic FDA data

TRIPLE ANTIBIOTIC

Product NDC
71205-006
11-digit product format
712050006
Labeler code
71205
Product ID
71205-006_92996a14-b98c-41d0-8519-2f66b294040d
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Proficient Rx LP
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-06-01
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [iU]/g; mg/g; [iU]/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 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [iU]/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
71205-006-28TRIPLE ANTIBIOTIC28 g in 1 TUBEOINTMENT286
71205-006-28TRIPLE ANTIBIOTIC1 in 1 CARTONOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-006-28GM - Gram71205-006e8584ac3-f54e-49b1-a8a2-cc2565de157d12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-006TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PROFICIENT RX LP]6Current NDC, Legacy NDC, 2 package rows20240201_949c5b44-ee52-4913-8872-39181d319998.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 OintmentPSN949c5b44-ee52-4913-8872-39181d3199986
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD949c5b44-ee52-4913-8872-39181d3199986
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY949c5b44-ee52-4913-8872-39181d3199986

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-006-28712050006281 TUBE in 1 CARTON (71205-006-28) / 28 g in 1 TUBE1 tube2018-04-020000-00-00NoNoCurrent