triple antibiotic

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

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name triple antibiotic
Generic Name bacitracin zinc, neomycin sulfate, and polymyxin b sulfate
Labeler topco associates llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 400 [iU]/g, neomycin sulfate 3.5 mg/g, polymyxin b sulfate 5000 [iU]/g

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-564
Product ID 36800-564_39fcb533-84a4-361f-e063-6294a90a94b6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2015-12-15

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 36800564
Hyphenated Format 36800-564

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, and polymyxin b sulfate (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 400 [iU]/g
  • 3.5 mg/g
  • 5000 [iU]/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (36800-564-01) / 14.2 g in 1 TUBE
  • 1 TUBE in 1 CARTON (36800-564-02) / 28.4 g in 1 TUBE
source: ndc

Packages (2)

36800-564-01 1 TUBE in 1 CARTON (36800-564-01) / 14.2 g in 1 TUBE 36800-564-02 1 TUBE in 1 CARTON (36800-564-02) / 28.4 g in 1 TUBE

Ingredients (3)

bacitracin zinc (400 [iU]/g) neomycin sulfate (3.5 mg/g) polymyxin b sulfate (5000 [iU]/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": "39fcb533-84a4-361f-e063-6294a90a94b6", "openfda": {"unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["55a8a52c-4d03-417d-9283-406f6879bcb5"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (36800-564-01)  / 14.2 g in 1 TUBE", "package_ndc": "36800-564-01", "marketing_start_date": "20161130"}, {"sample": false, "description": "1 TUBE in 1 CARTON (36800-564-02)  / 28.4 g in 1 TUBE", "package_ndc": "36800-564-02", "marketing_start_date": "20161130"}], "brand_name": "Triple Antibiotic", "product_id": "36800-564_39fcb533-84a4-361f-e063-6294a90a94b6", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "36800-564", "generic_name": "Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Triple Antibiotic", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "400 [iU]/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "5000 [iU]/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20151215", "listing_expiration_date": "20261231"}