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 69396-002
Product ID 69396-002_38f2e72b-340b-c56a-e063-6394a90a9a21
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2015-03-10

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 69396002
Hyphenated Format 69396-002

Supplemental Identifiers

RxCUI
204602
UPC
0094922041999 0850026393552 0850026393736 0850026393675
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
  • 1 TUBE in 1 BOX (69396-002-05) / 15 g in 1 TUBE
  • 144 PACKET in 1 BOX (69396-002-09) / .9 g in 1 PACKET
  • 1 TUBE in 1 BOX (69396-002-20) / 28.4 g in 1 TUBE
  • 1 TUBE in 1 BOX (69396-002-22) / 57 g in 1 TUBE
  • 2 TUBE in 1 BOX (69396-002-23) / 28.4 g in 1 TUBE
  • 25 PACKET in 1 BOX (69396-002-25) / .9 g in 1 PACKET
  • 3 TUBE in 1 BOX (69396-002-33) / 28.4 g in 1 TUBE
  • 4 TUBE in 1 BOX (69396-002-44) / 28.4 g in 1 TUBE
source: ndc

Packages (8)

69396-002-05 1 TUBE in 1 BOX (69396-002-05) / 15 g in 1 TUBE 69396-002-09 144 PACKET in 1 BOX (69396-002-09) / .9 g in 1 PACKET 69396-002-20 1 TUBE in 1 BOX (69396-002-20) / 28.4 g in 1 TUBE 69396-002-22 1 TUBE in 1 BOX (69396-002-22) / 57 g in 1 TUBE 69396-002-23 2 TUBE in 1 BOX (69396-002-23) / 28.4 g in 1 TUBE 69396-002-25 25 PACKET in 1 BOX (69396-002-25) / .9 g in 1 PACKET 69396-002-33 3 TUBE in 1 BOX (69396-002-33) / 28.4 g in 1 TUBE 69396-002-44 4 TUBE in 1 BOX (69396-002-44) / 28.4 g in 1 TUBE

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": "38f2e72b-340b-c56a-e063-6394a90a9a21", "openfda": {"upc": ["0094922041999", "0850026393552", "0850026393736", "0850026393675"], "unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["23a35ba8-ebc6-4252-bb88-ec237425056c"], "manufacturer_name": ["TRIFECTA PHARMACEUTICALS USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (69396-002-05)  / 15 g in 1 TUBE", "package_ndc": "69396-002-05", "marketing_start_date": "20160823"}, {"sample": false, "description": "144 PACKET in 1 BOX (69396-002-09)  / .9 g in 1 PACKET", "package_ndc": "69396-002-09", "marketing_start_date": "20220309"}, {"sample": false, "description": "1 TUBE in 1 BOX (69396-002-20)  / 28.4 g in 1 TUBE", "package_ndc": "69396-002-20", "marketing_start_date": "20170313"}, {"sample": false, "description": "1 TUBE in 1 BOX (69396-002-22)  / 57 g in 1 TUBE", "package_ndc": "69396-002-22", "marketing_start_date": "20220201"}, {"sample": false, "description": "2 TUBE in 1 BOX (69396-002-23)  / 28.4 g in 1 TUBE", "package_ndc": "69396-002-23", "marketing_start_date": "20240229"}, {"sample": false, "description": "25 PACKET in 1 BOX (69396-002-25)  / .9 g in 1 PACKET", "package_ndc": "69396-002-25", "marketing_start_date": "20230314"}, {"sample": false, "description": "3 TUBE in 1 BOX (69396-002-33)  / 28.4 g in 1 TUBE", "package_ndc": "69396-002-33", "marketing_start_date": "20240310"}, {"sample": false, "description": "4 TUBE in 1 BOX (69396-002-44)  / 28.4 g in 1 TUBE", "package_ndc": "69396-002-44", "marketing_start_date": "20240229"}], "brand_name": "Triple Antibiotic", "product_id": "69396-002_38f2e72b-340b-c56a-e063-6394a90a9a21", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "69396-002", "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": "20150310", "listing_expiration_date": "20261231"}