FDA.reportPublic FDA data

TRIBIOTIC

Product NDC
50332-0095
11-digit product format
503320095
Labeler code
50332
Product ID
50332-0095_aab57ea0-b3c1-49de-bbdd-14b519a8f7e9
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
HART Health
Application
M
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-02
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [iU]/g; mg/g; [iU]/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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [iU]/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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN3d17aba0-220f-42c4-9e26-5c44857847cd2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD3d17aba0-220f-42c4-9e26-5c44857847cd2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY3d17aba0-220f-42c4-9e26-5c44857847cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50332-0095-35033200950325 PACKET in 1 BOX, UNIT-DOSE (50332-0095-3) / .9 g in 1 PACKET25 packet2025-12-02NoNoHistorical
50332-0095-550332009505144 PACKET in 1 BOX, UNIT-DOSE (50332-0095-5) / .9 g in 1 PACKET144 packet2025-12-02NoNoHistorical
50332-0095-65033200950610 PACKET in 1 BOX, UNIT-DOSE (50332-0095-6) / .9 g in 1 PACKET10 packet2025-12-02NoNoHistorical
50332-0095-9503320095092000 PACKET in 1 BOX, UNIT-DOSE (50332-0095-9) / .9 g in 1 PACKET2000 packet2025-12-02NoNoHistorical