bacitracin zinc, neomycin sulfate, and polymyxin b sulfate

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

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

Drug Facts

Product Profile

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

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

Manufacturer
Henry Schein

Identifiers & Regulatory

Product NDC 0404-0167
Product ID 0404-0167_446e48e8-d3d2-e6e0-e063-6394a90ad444
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2022-11-03

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 04040167
Hyphenated Format 0404-0167

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 bacitracin zinc, neomycin sulfate, and polymyxin b sulfate (source: ndc)
Generic Name bacitracin zinc, neomycin sulfate, and 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
  • 1728 BOX in 1 CASE (0404-0167-50) / 144 PACKET in 1 BOX / .9 g in 1 PACKET
source: ndc

Packages (1)

0404-0167-50 1728 BOX in 1 CASE (0404-0167-50) / 144 PACKET in 1 BOX / .9 g in 1 PACKET

Ingredients (3)

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

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "446e48e8-d3d2-e6e0-e063-6394a90ad444", "openfda": {"unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["ead9496b-112e-59e6-e053-2995a90a768c"], "manufacturer_name": ["Henry Schein"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1728 BOX in 1 CASE (0404-0167-50)  / 144 PACKET in 1 BOX / .9 g in 1 PACKET", "package_ndc": "0404-0167-50", "marketing_start_date": "20221103"}], "brand_name": "Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate", "product_id": "0404-0167_446e48e8-d3d2-e6e0-e063-6394a90ad444", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "0404-0167", "generic_name": "Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate", "labeler_name": "Henry Schein", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate", "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": "20221103", "listing_expiration_date": "20261231"}