FDA.reportPublic FDA data

TRIPLE ANTIBIOTIC

Product NDC
50090-1859
11-digit product format
500901859
Labeler code
50090
Product ID
50090-1859_706f279f-0331-42d8-893f-e367cac94828
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc, neomycin, polymyxin B
Dosage form
OINTMENT
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-05-20
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1859-02023-02-07C16284748780-1f386c649-b114-0266-e053-dadaa90a7c1aTRIPLE ANTIBIOTIC
50090-1859-02023-01-30C16284748780-1f386c649-b114-0266-e053-dadaa90a7c1aTRIPLE ANTIBIOTIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1859-0TRIPLE ANTIBIOTIC1 in 1 CARTONOINTMENT113
50090-1859-0TRIPLE ANTIBIOTIC14 g in 1 TUBEOINTMENT1413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1859-0GM - Gram50090-1859be751855-e2e9-49d4-bebf-6a030ccb5a9d12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1859TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B) OINTMENT [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 2 package rows20241107_de07139e-ece9-424b-8468-f5ed4bbb2b2b.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 OintmentPSNde07139e-ece9-424b-8468-f5ed4bbb2b2b13
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCDde07139e-ece9-424b-8468-f5ed4bbb2b2b13
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSYde07139e-ece9-424b-8468-f5ed4bbb2b2b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1859-0500901859001 TUBE in 1 CARTON (50090-1859-0) / 14 g in 1 TUBE1 tube2015-06-080000-00-00NoNoCurrent