triple antibiotic

Generic: bacitracin zinc, neomycin sulfate, polymyxin b sulfate

Labeler: safetec of america, inc.
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 safetec of america, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 400 [iU]/g, neomycin sulfate 5 mg/g, polymyxin b sulfate 5000 [iU]/g

Manufacturer
Safetec of America, Inc.

Identifiers & Regulatory

Product NDC 61010-4400
Product ID 61010-4400_10aa746d-d831-277b-e063-6294a90ac9b8
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2022-07-25

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 610104400
Hyphenated Format 61010-4400

Supplemental Identifiers

RxCUI
204602
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 [iU]/g
  • 5 mg/g
  • 5000 [iU]/g
source: ndc
Packaging
  • 28 g in 1 TUBE (61010-4400-2)
source: ndc

Packages (1)

61010-4400-2 28 g in 1 TUBE (61010-4400-2)

Ingredients (3)

bacitracin zinc (400 [iU]/g) neomycin sulfate (5 mg/g) polymyxin b sulfate (5000 [iU]/g)

Linked Drug Pages (2)

Triple Antibiotic ndc-match (0.9) Triple Antibiotic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "10aa746d-d831-277b-e063-6294a90ac9b8", "openfda": {"unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["59494d5c-dd8a-431c-8e6a-4e1151ba7460"], "manufacturer_name": ["Safetec of America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 g in 1 TUBE (61010-4400-2)", "package_ndc": "61010-4400-2", "marketing_start_date": "20220725"}], "brand_name": "Triple Antibiotic", "product_id": "61010-4400_10aa746d-d831-277b-e063-6294a90ac9b8", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "61010-4400", "generic_name": "bacitracin zinc, neomycin sulfate, polymyxin b sulfate", "labeler_name": "Safetec of America, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Triple Antibiotic", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "400 [iU]/g"}, {"name": "NEOMYCIN SULFATE", "strength": "5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "5000 [iU]/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220725", "listing_expiration_date": "20261231"}