ProcureTriple Antibiotic

Product NDC
55681-216
11-digit product format
556810216
Labeler code
55681
Product ID
55681-216_37feb566-9772-cf1c-e063-6394a90abfba
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B
Dosage form
OINTMENT
Route
TOPICAL
Labeler
TWIN MED, LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-02-05
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 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
ProcureTriple Antibiotic
Brand name suffix
Triple Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55681-216-012021-09-28C16284748780-19d75b9cf-d823-f424-e053-dadaa90a57ceDrug Facts
55681-216-012020-01-31C16284748780-19d75b9cf-d823-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-216-01ProcureTriple AntibioticTriple Antibiotic0.9 g in 1 PACKETOINTMENT0.99
55681-216-02ProcureTriple AntibioticTriple Antibiotic28.3 g in 1 TUBEOINTMENT28.39

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55681-216PROCURETRIPLE ANTIBIOTIC TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B) OINTMENT [TWIN MED, LLC]8Current NDC, Legacy NDC, 2 package rows20240109_71592776-407b-489c-8cdb-8c0573d844f8.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 OintmentPSN71592776-407b-489c-8cdb-8c0573d844f89
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD71592776-407b-489c-8cdb-8c0573d844f89
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY71592776-407b-489c-8cdb-8c0573d844f89

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55681-216-0155681021601.9 g in 1 PACKET (55681-216-01) 2021-09-220000-00-00NoNoCurrent
55681-216-025568102160228.3 g in 1 TUBE (55681-216-02) 28.3 g2022-08-180000-00-00NoNoCurrent