FDA.reportPublic FDA data

ElixirTripleGuard

Product NDC
84546-0001
11-digit product format
845460001
Labeler code
84546
Product ID
84546-0001_45ded1dd-d9c1-555d-e063-6294a90a059e
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ELIXIR HEALTHCARE USA, LLC.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-24
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [USP'U]/g; mg/g; 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
ElixirTripleGuard
Brand name suffix
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84546-0001-1ElixirTripleGuardTriple Antibiotic28.3 g in 1 TUBEOINTMENT28.32
84546-0001-2ElixirTripleGuardTriple Antibiotic144 in 1 BOXOINTMENT1442
84546-0001-2ElixirTripleGuardTriple Antibiotic0.9 g in 1 PACKETOINTMENT0.92

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 OintmentPSN43edfb80-4d50-9362-e063-6394a90a21992
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD43edfb80-4d50-9362-e063-6394a90a21992
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY43edfb80-4d50-9362-e063-6394a90a21992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84546-0001-18454600010128.3 g in 1 TUBE (84546-0001-1) 28.3 g2025-12-24NoNoHistorical
84546-0001-284546000102144 PACKET in 1 BOX (84546-0001-2) / .9 g in 1 PACKET144 packet2025-12-24NoNoHistorical