FDA.reportPublic FDA data

Triple Antibiotic plus Lidocaine

Product NDC
69396-154
11-digit product format
693960154
Labeler code
69396
Product ID
69396-154_338c12c6-f312-fa55-e063-6294a90a7377
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate, Lidocaine
Dosage form
OINTMENT
Route
TOPICAL
Labeler
TRIFECTA PHARMACEUTICALS USA LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-31
Substance
BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
500; 40; 3.5; 10000 [USP'U]/g; mg/g; mg/g; [USP'U]/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Antiarrhythmic [EPC], Decreased Cell Wall Synthesis & Repair [PE], Local Anesthesia [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 plus Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g
LIDOCAINE40 mg/g
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 98PI200987, 057Y626693, 19371312D4
Rxcui308498

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-154-01Triple Antibiotic plus Lidocaine1 in 1 BOXOINTMENT14
69396-154-01Triple Antibiotic plus Lidocaine28.4 g in 1 TUBEOINTMENT28.44
69396-154-22Triple Antibiotic plus Lidocaine28.4 g in 1 TUBEOINTMENT28.44
69396-154-22Triple Antibiotic plus Lidocaine2 in 1 BOXOINTMENT24
69396-154-44Triple Antibiotic plus Lidocaine28.4 g in 1 TUBEOINTMENT28.44
69396-154-44Triple Antibiotic plus Lidocaine4 in 1 BOXOINTMENT44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-154TRIPLE ANTIBIOTIC PLUS LIDOCAINE (BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE, LIDOCAINE) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]4Current NDC, 6 package rows20250426_14fda967-54ba-c964-e063-6294a90a21ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308498bacitracin 500 UNT / lidocaine 40 MG / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Topical OintmentPSN14fda967-54ba-c964-e063-6294a90a21ee4
308498bacitracin 0.5 UNT/MG / lidocaine 0.04 MG/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Topical OintmentSCD14fda967-54ba-c964-e063-6294a90a21ee4
308498bacitracin 500 UNT / lidocaine 40 MG / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 10,000 UNT per GM Topical OintmentSY14fda967-54ba-c964-e063-6294a90a21ee4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-154-01693960154011 TUBE in 1 BOX (69396-154-01) / 28.4 g in 1 TUBE1 tube2024-03-31NoNoHistorical
69396-154-22693960154222 TUBE in 1 BOX (69396-154-22) / 28.4 g in 1 TUBE2 tube2024-06-26NoNoHistorical
69396-154-44693960154444 TUBE in 1 BOX (69396-154-44) / 28.4 g in 1 TUBE4 tube2024-03-31NoNoHistorical