FDA.reportPublic FDA data

TRIPLE ANTIBIOTIC

Product NDC
84722-3032
11-digit product format
847223032
Labeler code
84722
Product ID
84722-3032_236c62bf-3de1-0b3e-e063-6394a90ad6c6
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Vive Health LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-01
Substance
BACITRACIN; NEOMYCIN; POLYMYXIN B
Active strength
400; 3.5; 5000 [USP'U]/1; mg/1; [USP'U]/1
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
BACITRACIN400 [USP'U]/1
NEOMYCIN3.5 mg/1
POLYMYXIN B5000 [USP'U]/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii58H6RWO52I, I16QD7X297, J2VZ07J96K
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
84722-3032-1TRIPLE ANTIBIOTIC1 in 1 TUBEOINTMENT12
84722-3032-0TRIPLE ANTIBIOTIC144 in 1 PACKETOINTMENT1441

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84722-3032TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [VIVE HEALTH LLC]2Current NDC, 1 package rows20241206_21b38b00-1e64-83d8-e063-6294a90a07bd.zip
84722-3032TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [VIVE HEALTH LLC]1Current NDC, 1 package rows20241003_236c62bf-3de0-0b3e-e063-6394a90ad6c6.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 OintmentPSN21b38b00-1e64-83d8-e063-6294a90a07bd2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD21b38b00-1e64-83d8-e063-6294a90a07bd2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY21b38b00-1e64-83d8-e063-6294a90a07bd2
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN236c62bf-3de0-0b3e-e063-6394a90ad6c61
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD236c62bf-3de0-0b3e-e063-6394a90ad6c61
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY236c62bf-3de0-0b3e-e063-6394a90ad6c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84722-3032-084722303200144 OINTMENT in 1 PACKET (84722-3032-0) 144 ointment2024-10-01NoNoHistorical
84722-3032-1847223032011 OINTMENT in 1 TUBE (84722-3032-1) 1 ointment2024-09-23NoNoHistorical