FDA.reportPublic FDA data

TRIPLE ANTIBIOTIC

Product NDC
73598-1004
11-digit product format
735981004
Labeler code
73598
Product ID
73598-1004_1b96edfa-c13e-41e7-a0a4-bdfcdccd6bc3
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC, NEOMYCIN SULFATE, and POLYMYXIN B SULFATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
JHK Inc dba American Safety & First Aid
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-02-02
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [iU]/.5g; mg/.5g; [iU]/.5g
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
TRIPLE ANTIBIOTIC
Listing expiration
2026-12-31

Active Ingredients#

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

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
73598-1004-12024-04-26C16284748780-11030e365-4afe-111a-e063-dadaa90a10e2TRIPLE ANTIBIOTIC
73598-1004-12024-01-30C16284748780-11030e365-4afe-111a-e063-dadaa90a10e2TRIPLE ANTIBIOTIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73598-1004-1TRIPLE ANTIBIOTIC25 in 1 BOXOINTMENT252
73598-1004-1TRIPLE ANTIBIOTIC0.5 g in 1 POUCHOINTMENT0.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73598-1004TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [JHK INC DBA AMERICAN SAFETY & FIRST AID]2Current NDC, Legacy NDC, 2 package rows20240427_26e66025-9457-42b3-9319-51302c17506e.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 OintmentPSN26e66025-9457-42b3-9319-51302c17506e2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD26e66025-9457-42b3-9319-51302c17506e2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY26e66025-9457-42b3-9319-51302c17506e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73598-1004-17359810040125 POUCH in 1 BOX (73598-1004-1) / .5 g in 1 POUCH25 pouch2000-02-020000-00-00NoNoCurrent