FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
61010-5600
11-digit product format
610105600
Labeler code
61010
Product ID
61010-5600_10d3b150-077e-cb76-e063-6394a90ab356
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
2011-08-08
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-5600-12024-02-13C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment
61010-5600-22024-02-13C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment
61010-5600-32024-02-13C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment
61010-5600-42024-02-13C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment
61010-5600-12024-01-30C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment
61010-5600-22024-01-30C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment
61010-5600-32024-01-30C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment
61010-5600-42024-01-30C16284748780-11030e365-68e7-111a-e063-dadaa90a10e261010-5600, Triple Antibiotic Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-5600-1Triple Antibiotic0.9 g in 1 POUCHOINTMENT0.96
61010-5600-2Triple Antibiotic144 in 1 BOXOINTMENT1446
61010-5600-2Triple Antibiotic0.9 g in 1 POUCHOINTMENT0.96
61010-5600-3Triple Antibiotic25 in 1 BOXOINTMENT256
61010-5600-3Triple Antibiotic0.9 g in 1 POUCHOINTMENT0.96
61010-5600-4Triple Antibiotic10 in 1 BOXOINTMENT106
61010-5600-4Triple Antibiotic0.9 g in 1 PACKETOINTMENT0.96

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
bacitracin zincACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]1
neomycin sulfateACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]1
polymyxin b sulfateACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]1
bacitracin zincACTIVE MOIETY89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]1
neomycinACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]1
polymyxin bACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-5600TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.]6Current NDC, Legacy NDC, 7 package rows20240214_96c41fc1-81f9-4757-abc6-867b5383ed5d.zip
61010-5600CARE SCIENCE ESSENTIAL FIRST AID (ETHYL ALCOHOL, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE) KIT [ASO LLC]3Current NDC, Legacy NDC20240830_4e53fc6b-4774-4224-8759-eadd150ff959.zip
61010-5600CARE SCIENCE OSHA FIRST AID (ETHYL ALCOHOL, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, DIPHENHYDRAMINE HYDROCHLORIDE, HYDROCORTISONE, IBUPROFEN, ACETAMINOPHEN, WATER) KIT [ASO LLC]2Current NDC, Legacy NDC20241107_1cbace4d-fd0a-41d1-aa71-907d43620bf8.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 OintmentPSN96c41fc1-81f9-4757-abc6-867b5383ed5d6
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD96c41fc1-81f9-4757-abc6-867b5383ed5d6
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY96c41fc1-81f9-4757-abc6-867b5383ed5d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-5600-161010560001.9 g in 1 POUCH (61010-5600-1) 2011-08-080000-00-00NoNoCurrent
61010-5600-261010560002144 POUCH in 1 BOX (61010-5600-2) / .9 g in 1 POUCH144 pouch2011-08-080000-00-00NoNoCurrent
61010-5600-36101056000325 POUCH in 1 BOX (61010-5600-3) / .9 g in 1 POUCH25 pouch2011-08-080000-00-00NoNoCurrent
61010-5600-46101056000410 PACKET in 1 BOX (61010-5600-4) / .9 g in 1 PACKET10 packet2020-04-010000-00-00NoNoCurrent