FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
61010-4400
11-digit product format
610104400
Labeler code
61010
Product ID
61010-4400_10aa39d8-0c61-1391-e063-6294a90a5925
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin sulfate, polymyxin b sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-01
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 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 SULFATE5 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-4400-12024-02-13C16284748780-11030e365-2963-111a-e063-dadaa90a10e261010-4400-1, Triple Antibiotic tube
61010-4400-22024-02-13C16284748780-11030e365-2b02-111a-e063-dadaa90a10e261010-4400-2, Triple Antibiotic
61010-4400-12024-01-30C16284748780-11030e365-2963-111a-e063-dadaa90a10e261010-4400-1, Triple Antibiotic tube
61010-4400-22024-01-30C16284748780-11030e365-2b02-111a-e063-dadaa90a10e261010-4400-2, Triple Antibiotic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-4400-1Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.42
61010-4400-2Triple Antibiotic28 g in 1 TUBEOINTMENT282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-4400TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]2Current NDC, Legacy NDC, 1 package rows20240214_03c05028-5a5f-4690-a836-cc1b1044ab39.zip
61010-4400TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]2Current NDC, Legacy NDC, 1 package rows20240214_59494d5c-dd8a-431c-8e6a-4e1151ba7460.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 OintmentPSN03c05028-5a5f-4690-a836-cc1b1044ab392
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN59494d5c-dd8a-431c-8e6a-4e1151ba74602
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD03c05028-5a5f-4690-a836-cc1b1044ab392
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD59494d5c-dd8a-431c-8e6a-4e1151ba74602
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY03c05028-5a5f-4690-a836-cc1b1044ab392
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY59494d5c-dd8a-431c-8e6a-4e1151ba74602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-4400-16101044000128.4 g in 1 TUBE (61010-4400-1) 28.4 g2019-11-010000-00-00NoNoCurrent
61010-4400-26101044000228 g in 1 TUBE (61010-4400-2) 28 g2022-07-250000-00-00NoNoCurrent