FDA.reportPublic FDA data

MediChoice Triple Antibiotic

Product NDC
39892-0830
11-digit product format
398920830
Labeler code
39892
Product ID
39892-0830_40b405f4-b084-33f2-e063-6294a90a1027
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
O&M HALYARD, INC.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-27
Substance
BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MediChoice Triple Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN400 [iU]/g
NEOMYCIN SULFATE5 mg/g
POLYMYXIN B SULFATE5000 [iU]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii58H6RWO52I, 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
39892-0830-1MediChoice Triple Antibiotic144 in 1 CARTONOINTMENT1446
39892-0830-1MediChoice Triple Antibiotic0.9 g in 1 PACKETOINTMENT0.96

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52IMEDICHOICE TRIPLE ANTIBIOTIC (BACITRACIN) OINTMENT [OWENS & MINOR INC.]2
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693MEDICHOICE TRIPLE ANTIBIOTIC (BACITRACIN) OINTMENT [OWENS & MINOR INC.]2
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4MEDICHOICE TRIPLE ANTIBIOTIC (BACITRACIN) OINTMENT [OWENS & MINOR INC.]2
BACITRACINACTIVE MOIETY58H6RWO52IMEDICHOICE TRIPLE ANTIBIOTIC (BACITRACIN) OINTMENT [OWENS & MINOR INC.]2
NEOMYCINACTIVE MOIETYI16QD7X297MEDICHOICE TRIPLE ANTIBIOTIC (BACITRACIN) OINTMENT [OWENS & MINOR INC.]2
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KMEDICHOICE TRIPLE ANTIBIOTIC (BACITRACIN) OINTMENT [OWENS & MINOR INC.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UMEDICHOICE TRIPLE ANTIBIOTIC (BACITRACIN) OINTMENT [OWENS & MINOR INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39892-0830MEDICHOICE TRIPLE ANTIBIOTIC (BACITRACIN) OINTMENT [OWENS & MINOR INC.]5Current NDC, Legacy NDC, 2 package rows20231210_8369f399-6f64-4441-be72-1f16c7306c0a.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 OintmentPSN8369f399-6f64-4441-be72-1f16c7306c0a6
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD8369f399-6f64-4441-be72-1f16c7306c0a6
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY8369f399-6f64-4441-be72-1f16c7306c0a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39892-0830-139892083001144 PACKET in 1 CARTON (39892-0830-1) / .9 g in 1 PACKET144 packet2015-03-270000-00-00NoNoCurrent