FDA.reportPublic FDA data

TRIPLE ANTIBIOTIC

Product NDC
21922-093
11-digit product format
219220093
Labeler code
21922
Product ID
21922-093_f5be6d0e-4fad-46d7-8d9c-925b382e2637
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc neomycin sulfate polymyxin b sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-06
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 5000 [USP'U]/g; mg/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
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 [USP'U]/g
NEOMYCIN SULFATE3.5 mg/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
21922-093-04TRIPLE ANTIBIOTIC14 g in 1 TUBEOINTMENT142
21922-093-04TRIPLE ANTIBIOTIC1 in 1 CARTONOINTMENT12
21922-093-05TRIPLE ANTIBIOTIC28 g in 1 TUBEOINTMENT282
21922-093-05TRIPLE ANTIBIOTIC1 in 1 CARTONOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-093-05GM - Gram21922-09379fa5a91-4d19-4ebe-a7e5-6422561612d212025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-093TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED]1Current NDC, 4 package rows20250330_2e985ad0-aa50-4c6b-b0af-1d61489a9fda.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 OintmentPSN2e985ad0-aa50-4c6b-b0af-1d61489a9fda2
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD2e985ad0-aa50-4c6b-b0af-1d61489a9fda2
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY2e985ad0-aa50-4c6b-b0af-1d61489a9fda2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-093-04219220093041 TUBE in 1 CARTON (21922-093-04) / 14 g in 1 TUBE1 tube2025-03-06NoNoHistorical
21922-093-05219220093051 TUBE in 1 CARTON (21922-093-05) / 28 g in 1 TUBE1 tube2025-03-06NoNoHistorical