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

Manufacturer
Safetec of America, Inc.

Identifiers & Regulatory

Product NDC 61010-5600
Product ID 61010-5600_10d3b150-077e-cb76-e063-6394a90ab356
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2011-08-08

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 610105600
Hyphenated Format 61010-5600

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 [USP'U]/g
  • 3.5 mg/g
  • 5000 [USP'U]/g
source: ndc
Packaging
  • .9 g in 1 POUCH (61010-5600-1)
  • 144 POUCH in 1 BOX (61010-5600-2) / .9 g in 1 POUCH
  • 25 POUCH in 1 BOX (61010-5600-3) / .9 g in 1 POUCH
  • 10 PACKET in 1 BOX (61010-5600-4) / .9 g in 1 PACKET
source: ndc

Packages (4)

61010-5600-1 .9 g in 1 POUCH (61010-5600-1) 61010-5600-2 144 POUCH in 1 BOX (61010-5600-2) / .9 g in 1 POUCH 61010-5600-3 25 POUCH in 1 BOX (61010-5600-3) / .9 g in 1 POUCH 61010-5600-4 10 PACKET in 1 BOX (61010-5600-4) / .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": "10d3b150-077e-cb76-e063-6394a90ab356", "openfda": {"unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["96c41fc1-81f9-4757-abc6-867b5383ed5d"], "manufacturer_name": ["Safetec of America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": ".9 g in 1 POUCH (61010-5600-1)", "package_ndc": "61010-5600-1", "marketing_start_date": "20110808"}, {"sample": false, "description": "144 POUCH in 1 BOX (61010-5600-2)  / .9 g in 1 POUCH", "package_ndc": "61010-5600-2", "marketing_start_date": "20110808"}, {"sample": false, "description": "25 POUCH in 1 BOX (61010-5600-3)  / .9 g in 1 POUCH", "package_ndc": "61010-5600-3", "marketing_start_date": "20110808"}, {"sample": false, "description": "10 PACKET in 1 BOX (61010-5600-4)  / .9 g in 1 PACKET", "package_ndc": "61010-5600-4", "marketing_start_date": "20200401"}], "brand_name": "Triple Antibiotic", "product_id": "61010-5600_10d3b150-077e-cb76-e063-6394a90ab356", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "61010-5600", "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 [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": "20110808", "listing_expiration_date": "20261231"}