major triple antibiotic

Generic: bacitracin zinc, neomycin, polymyxin b sulfat

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name major triple antibiotic
Generic Name bacitracin zinc, neomycin, polymyxin b sulfat
Labeler major pharmaceuticals
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
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-8805
Product ID 0904-8805_21dbd44e-7fb5-874e-e063-6394a90a4e8b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2020-04-20

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 09048805
Hyphenated Format 0904-8805

Supplemental Identifiers

RxCUI
204602
UPC
0309048805319 0309048805678
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 major triple antibiotic (source: ndc)
Generic Name bacitracin zinc, neomycin, polymyxin b sulfat (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
  • 1 TUBE in 1 BOX (0904-8805-31) / 28 g in 1 TUBE
  • 144 PACKET in 1 CARTON (0904-8805-67) / .9 g in 1 PACKET
source: ndc

Packages (2)

0904-8805-31 1 TUBE in 1 BOX (0904-8805-31) / 28 g in 1 TUBE 0904-8805-67 144 PACKET in 1 CARTON (0904-8805-67) / .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)

Major Triple Antibiotic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "21dbd44e-7fb5-874e-e063-6394a90a4e8b", "openfda": {"upc": ["0309048805319", "0309048805678"], "unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["a6cc3fbc-6302-4033-e053-2a95a90a19f0"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (0904-8805-31)  / 28 g in 1 TUBE", "package_ndc": "0904-8805-31", "marketing_start_date": "20240820"}, {"sample": false, "description": "144 PACKET in 1 CARTON (0904-8805-67)  / .9 g in 1 PACKET", "package_ndc": "0904-8805-67", "marketing_start_date": "20200529"}], "brand_name": "Major Triple Antibiotic", "product_id": "0904-8805_21dbd44e-7fb5-874e-e063-6394a90a4e8b", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "0904-8805", "generic_name": "Bacitracin Zinc, Neomycin, Polymyxin B Sulfat", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Major 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": "20200420", "listing_expiration_date": "20261231"}