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 69396-125
Product ID 69396-125_29b3ceb4-42e3-3a65-e063-6294a90a788c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2023-07-18

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 69396125
Hyphenated Format 69396-125

Supplemental Identifiers

RxCUI
204602
UPC
0855413007593
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
  • 25 PACKET in 1 BOX (69396-125-05) / .5 g in 1 PACKET
source: ndc

Packages (1)

69396-125-05 25 PACKET in 1 BOX (69396-125-05) / .5 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": "29b3ceb4-42e3-3a65-e063-6294a90a788c", "openfda": {"upc": ["0855413007593"], "unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["00c52a31-9bfa-a8bf-e063-6294a90ac4d7"], "manufacturer_name": ["TRIFECTA PHARMACEUTICALS USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 PACKET in 1 BOX (69396-125-05)  / .5 g in 1 PACKET", "package_ndc": "69396-125-05", "marketing_start_date": "20230723"}], "brand_name": "Triple Antibiotic", "product_id": "69396-125_29b3ceb4-42e3-3a65-e063-6294a90a788c", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "69396-125", "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": "20230718", "listing_expiration_date": "20261231"}