FDA.reportPublic FDA data

TRIPLE ANTIBIOTIC

Product NDC
84722-3032
11-digit product format
847223032
Labeler code
84722
Product ID
84722-3032_57248739-675b-1867-e063-6294a90a7681
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
POLYMYXIN B; BACITRACIN; NEOMYCIN
Active strength
5000; 400; 3.5 [USP'U]/1; [USP'U]/1; mg/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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
TRIPLE ANTIBIOTIC
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYMYXIN B5000 [USP'U]/1
BACITRACIN400 [USP'U]/1
NEOMYCIN3.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J2VZ07J96KInternal UNII lookup
58H6RWO52IInternal UNII lookup
I16QD7X297Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204602Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
236c62bf-3de0-0b3e-e063-6394a90ad6c6Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 22 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEFRONT PHARMACEUTICAL PLCcb7fdcde-2bd8-4834-ba4e-4d6fd15125992023-10-26WarningsExact identifier
application number: M004
GENUINE FIRST AID AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.23abfe12-5b50-4b49-878e-4fcdb6c341fd2023-10-19WarningsExact identifier
application number: M004
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
application number: M004
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
application number: M004

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 ointment2024-10-01NoNoCurrent
84722-3032-1847223032014 OINTMENT in 1 TUBE (84722-3032-1) 4 ointment2024-09-23NoNoCurrent