FDA.reportPublic FDA data

Thera Plus Original Strength Triple Antibiotic

Product NDC
80684-198
11-digit product format
806840198
Labeler code
80684
Product ID
80684-198_44fbe805-2f02-fcac-e063-6394a90ad403
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Fourstar Group USA, Inc
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-20
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
Thera Plus Original Strength 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-198-00Thera Plus Original Strength Triple Antibiotic6 in 1 BOXOINTMENT61
80684-198-00Thera Plus Original Strength Triple Antibiotic0.9 g in 1 PACKETOINTMENT0.91

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 OintmentPSN2f916502-4daf-4cb9-a638-f37bb96c80771
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD2f916502-4daf-4cb9-a638-f37bb96c80771
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY2f916502-4daf-4cb9-a638-f37bb96c80771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80684-198-00806840198006 PACKET in 1 BOX (80684-198-00) / .9 g in 1 PACKET6 packet2025-11-20NoNoHistorical