triple antibiotic

Generic: bacitracin zinc and neomycin and polymyxin b sulfate

Labeler: melaleuca, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name triple antibiotic
Generic Name bacitracin zinc and neomycin and polymyxin b sulfate
Labeler melaleuca, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 500 U/g, neomycin sulfate 3.5 mg/g, polymyxin b sulfate 10000 U/g

Manufacturer
Melaleuca, Inc.

Identifiers & Regulatory

Product NDC 54473-291
Product ID 54473-291_4747f7af-efc5-1b57-e063-6294a90adb8c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 1995-07-01

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 54473291
Hyphenated Format 54473-291

Supplemental Identifiers

RxCUI
1359363
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 and neomycin and polymyxin b sulfate (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 500 U/g
  • 3.5 mg/g
  • 10000 U/g
source: ndc
Packaging
  • 14 g in 1 TUBE (54473-291-01)
source: ndc

Packages (1)

54473-291-01 14 g in 1 TUBE (54473-291-01)

Ingredients (3)

bacitracin zinc (500 U/g) neomycin sulfate (3.5 mg/g) polymyxin b sulfate (10000 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": "4747f7af-efc5-1b57-e063-6294a90adb8c", "openfda": {"unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["1359363"], "spl_set_id": ["65ae4607-689d-6056-e053-2a91aa0aff56"], "manufacturer_name": ["Melaleuca, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 g in 1 TUBE (54473-291-01)", "package_ndc": "54473-291-01", "marketing_start_date": "20180101"}], "brand_name": "Triple Antibiotic", "product_id": "54473-291_4747f7af-efc5-1b57-e063-6294a90adb8c", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "54473-291", "generic_name": "Bacitracin zinc and Neomycin and Polymyxin B sulfate", "labeler_name": "Melaleuca, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Triple Antibiotic", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "500 U/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 U/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19950701", "listing_expiration_date": "20261231"}