triple antibiotic

Generic: bacitracin zinc, neomycin sulfate, polymyxin b sulfate

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

Drug Facts

Product Profile

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

bacitracin zinc 400 [USP'U]/g, neomycin sulfate 3.5 mg/g, polymyxin b sulfate 5000 [USP'U]/g

Manufacturer
Trifecta Pharmaceuticals USA LLC

Identifiers & Regulatory

Product NDC 69396-135
Product ID 69396-135_2a920704-0306-b340-e063-6394a90ae5dc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2023-10-23

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs] decreased cell wall synthesis & repair [pe] polymyxin-class antibacterial [epc] polymyxins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69396135
Hyphenated Format 69396-135

Supplemental Identifiers

RxCUI
204602
UPC
0850026393859
UNII
89Y4M234ES 057Y626693 19371312D4

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 (source: ndc)
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b sulfate (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 400 [USP'U]/g
  • 3.5 mg/g
  • 5000 [USP'U]/g
source: ndc
Packaging
  • 10 PACKET in 1 CARTON (69396-135-10) / .9 g in 1 PACKET
  • 25 PACKET in 1 CARTON (69396-135-25) / .9 g in 1 PACKET
source: ndc

Packages (2)

69396-135-10 10 PACKET in 1 CARTON (69396-135-10) / .9 g in 1 PACKET 69396-135-25 25 PACKET in 1 CARTON (69396-135-25) / .9 g in 1 PACKET

Ingredients (3)

bacitracin zinc (400 [USP'U]/g) neomycin sulfate (3.5 mg/g) polymyxin b sulfate (5000 [USP'U]/g)

Linked Drug Pages (1)

Triple Antibiotic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2a920704-0306-b340-e063-6394a90ae5dc", "openfda": {"upc": ["0850026393859"], "unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["087694c2-4b1b-e293-e063-6294a90a961f"], "manufacturer_name": ["Trifecta Pharmaceuticals USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 PACKET in 1 CARTON (69396-135-10)  / .9 g in 1 PACKET", "package_ndc": "69396-135-10", "marketing_start_date": "20231023"}, {"sample": false, "description": "25 PACKET in 1 CARTON (69396-135-25)  / .9 g in 1 PACKET", "package_ndc": "69396-135-25", "marketing_start_date": "20231023"}], "brand_name": "Triple Antibiotic", "product_id": "69396-135_2a920704-0306-b340-e063-6394a90ae5dc", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "69396-135", "generic_name": "Bacitracin zinc, Neomycin Sulfate, Polymyxin B Sulfate", "labeler_name": "Trifecta Pharmaceuticals USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Triple Antibiotic", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "400 [USP'U]/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "5000 [USP'U]/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231023", "listing_expiration_date": "20261231"}