FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
36800-564
11-digit product format
368000564
Labeler code
36800
Product ID
36800-564_39fcb533-84a4-361f-e063-6294a90a94b6
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-12-15
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400; 3.5; 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
Triple Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [iU]/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE5000 [iU]/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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
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
36800-564-01Triple Antibiotic1 in 1 CARTONOINTMENT15
36800-564-01Triple Antibiotic14.2 g in 1 TUBEOINTMENT14.25
36800-564-02Triple Antibiotic1 in 1 CARTONOINTMENT15
36800-564-02Triple Antibiotic28.4 g in 1 TUBEOINTMENT28.45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-564TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 4 package rows20241109_55a8a52c-4d03-417d-9283-406f6879bcb5.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 OintmentPSN55a8a52c-4d03-417d-9283-406f6879bcb55
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD55a8a52c-4d03-417d-9283-406f6879bcb55
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY55a8a52c-4d03-417d-9283-406f6879bcb55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-564-01368000564011 TUBE in 1 CARTON (36800-564-01) / 14.2 g in 1 TUBE1 tube2016-11-300000-00-00NoNoCurrent
36800-564-02368000564021 TUBE in 1 CARTON (36800-564-02) / 28.4 g in 1 TUBE1 tube2016-11-300000-00-00NoNoCurrent