FDA.reportPublic FDA data

Ora Zen Triple Antibiotic

Product NDC
71927-034
11-digit product format
719270034
Labeler code
71927
Product ID
71927-034_4cc7d45b-44bd-c250-e063-6294a90a54d0
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Orazen Inc
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-11
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; .0035; 5000 [USP'U]/g; g/g; [USP'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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ora Zen Triple Antibiotic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [USP'U]/g
NEOMYCIN SULFATE.0035 g/g
POLYMYXIN B SULFATE5000 [USP'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
71927-034-01Ora Zen Triple Antibiotic0.5 g in 1 POUCHOINTMENT0.51
71927-034-02Ora Zen Triple Antibiotic25 in 1 BOXOINTMENT251

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 OintmentPSN503c6c0e-3e1a-71ed-e063-6394a90abfa21
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSNabbf8c34-87cb-4366-9840-7264a5114b541
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD503c6c0e-3e1a-71ed-e063-6394a90abfa21
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDabbf8c34-87cb-4366-9840-7264a5114b541
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY503c6c0e-3e1a-71ed-e063-6394a90abfa21
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYabbf8c34-87cb-4366-9840-7264a5114b541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71927-034-01719270034010.5 g in 1 POUCH0.5 gHistorical
71927-034-027192700340225 POUCH in 1 BOX (71927-034-02) / .5 g in 1 POUCH (71927-034-01) 25 pouch2026-03-11NoNoCurrent