triple antibiotic plus lidocaine

Generic: bacitracin zinc, neomycin sulfate , polymyxin b sulfate, lidocaine

Labeler: trifecta pharmaceuticals usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name triple antibiotic plus lidocaine
Generic Name bacitracin zinc, neomycin sulfate , polymyxin b sulfate, lidocaine
Labeler trifecta pharmaceuticals usa llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 500 [USP'U]/g, lidocaine 40 mg/g, neomycin sulfate 3.5 mg/g, polymyxin b sulfate 10000 [USP'U]/g

Manufacturer
TRIFECTA PHARMACEUTICALS USA LLC

Identifiers & Regulatory

Product NDC 69396-154
Product ID 69396-154_338c12c6-f312-fa55-e063-6294a90a7377
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2024-03-31

Pharmacologic Class

Established (EPC)
amide local anesthetic [epc] antiarrhythmic [epc]
Chemical Structure
amides [cs]
Physiologic Effect
local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69396154
Hyphenated Format 69396-154

Supplemental Identifiers

RxCUI
308498
UPC
0850058161112
UNII
89Y4M234ES 98PI200987 057Y626693 19371312D4
NUI
N0000175682 M0000897 N0000175426 N0000175976

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name triple antibiotic plus lidocaine (source: ndc)
Generic Name bacitracin zinc, neomycin sulfate , polymyxin b sulfate, lidocaine (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 500 [USP'U]/g
  • 40 mg/g
  • 3.5 mg/g
  • 10000 [USP'U]/g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (69396-154-01) / 28.4 g in 1 TUBE
  • 2 TUBE in 1 BOX (69396-154-22) / 28.4 g in 1 TUBE
  • 4 TUBE in 1 BOX (69396-154-44) / 28.4 g in 1 TUBE
source: ndc

Packages (3)

69396-154-01 1 TUBE in 1 BOX (69396-154-01) / 28.4 g in 1 TUBE 69396-154-22 2 TUBE in 1 BOX (69396-154-22) / 28.4 g in 1 TUBE 69396-154-44 4 TUBE in 1 BOX (69396-154-44) / 28.4 g in 1 TUBE

Ingredients (4)

bacitracin zinc (500 [USP'U]/g) lidocaine (40 mg/g) neomycin sulfate (3.5 mg/g) polymyxin b sulfate (10000 [USP'U]/g)

Linked Drug Pages (1)

Triple Antibiotic plus Lidocaine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "338c12c6-f312-fa55-e063-6294a90a7377", "openfda": {"nui": ["N0000175682", "M0000897", "N0000175426", "N0000175976"], "upc": ["0850058161112"], "unii": ["89Y4M234ES", "98PI200987", "057Y626693", "19371312D4"], "rxcui": ["308498"], "spl_set_id": ["14fda967-54ba-c964-e063-6294a90a21ee"], "pharm_class_cs": ["Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Amide Local Anesthetic [EPC]", "Antiarrhythmic [EPC]"], "manufacturer_name": ["TRIFECTA PHARMACEUTICALS USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (69396-154-01)  / 28.4 g in 1 TUBE", "package_ndc": "69396-154-01", "marketing_start_date": "20240331"}, {"sample": false, "description": "2 TUBE in 1 BOX (69396-154-22)  / 28.4 g in 1 TUBE", "package_ndc": "69396-154-22", "marketing_start_date": "20240626"}, {"sample": false, "description": "4 TUBE in 1 BOX (69396-154-44)  / 28.4 g in 1 TUBE", "package_ndc": "69396-154-44", "marketing_start_date": "20240331"}], "brand_name": "Triple Antibiotic plus Lidocaine", "product_id": "69396-154_338c12c6-f312-fa55-e063-6294a90a7377", "dosage_form": "OINTMENT", "pharm_class": ["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]"], "product_ndc": "69396-154", "generic_name": "Bacitracin zinc, Neomycin sulfate , Polymyxin B sulfate, Lidocaine", "labeler_name": "TRIFECTA PHARMACEUTICALS USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Triple Antibiotic plus Lidocaine", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "500 [USP'U]/g"}, {"name": "LIDOCAINE", "strength": "40 mg/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240331", "listing_expiration_date": "20261231"}