bacitracin zinc, polymyxin b sulfate, and neomycin sulfate

Generic: bacitracin zinc, polymyxin b sulfate, and neomycin sulfate

Labeler: henry schein
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name bacitracin zinc, polymyxin b sulfate, and neomycin sulfate
Generic Name bacitracin zinc, polymyxin b sulfate, and neomycin sulfate
Labeler henry schein
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 400 [iU]/g, neomycin sulfate 5 mg/g, polymyxin b sulfate 50000 [iU]/g

Manufacturer
Henry Schein

Identifiers & Regulatory

Product NDC 0404-0171
Product ID 0404-0171_446e5eab-25ec-f12c-e063-6394a90a9c12
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2022-11-04

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 04040171
Hyphenated Format 0404-0171

Supplemental Identifiers

RxCUI
204602
UPC
0304040171509
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 bacitracin zinc, polymyxin b sulfate, and neomycin sulfate (source: ndc)
Generic Name bacitracin zinc, polymyxin b sulfate, and neomycin sulfate (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 400 [iU]/g
  • 5 mg/g
  • 50000 [iU]/g
source: ndc
Packaging
  • 72 BOX in 1 CASE (0404-0171-50) / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE
source: ndc

Packages (1)

0404-0171-50 72 BOX in 1 CASE (0404-0171-50) / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE

Ingredients (3)

bacitracin zinc (400 [iU]/g) neomycin sulfate (5 mg/g) polymyxin b sulfate (50000 [iU]/g)

Linked Drug Pages (1)

Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "446e5eab-25ec-f12c-e063-6394a90a9c12", "openfda": {"upc": ["0304040171509"], "unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["eadb847e-aefe-41cf-e053-2995a90af2cd"], "manufacturer_name": ["Henry Schein"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "72 BOX in 1 CASE (0404-0171-50)  / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE", "package_ndc": "0404-0171-50", "marketing_start_date": "20221104"}], "brand_name": "Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate", "product_id": "0404-0171_446e5eab-25ec-f12c-e063-6394a90a9c12", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "0404-0171", "generic_name": "Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate", "labeler_name": "Henry Schein", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "400 [iU]/g"}, {"name": "NEOMYCIN SULFATE", "strength": "5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "50000 [iU]/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20221104", "listing_expiration_date": "20261231"}