triple antibiotic 01

Generic: bacitracin zinc, neomycin sulfate, polymyxin b sulfate

Labeler: cosmuses cosmetics (ningbo) co., ltd.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name triple antibiotic 01
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b sulfate
Labeler cosmuses cosmetics (ningbo) co., ltd.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 400 U/g, neomycin sulfate 3.5 mg/g, polymyxin b sulfate 5000 U/g

Manufacturer
Cosmuses Cosmetics (Ningbo) Co., Ltd.

Identifiers & Regulatory

Product NDC 82953-013
Product ID 82953-013_0e1b75c1-96b6-e939-e063-6394a90abffc
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2024-01-04

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 82953013
Hyphenated Format 82953-013

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 01 (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 U/g
  • 3.5 mg/g
  • 5000 U/g
source: ndc
Packaging
  • .9 g in 1 BAG (82953-013-01)
source: ndc

Packages (1)

82953-013-01 .9 g in 1 BAG (82953-013-01)

Ingredients (3)

bacitracin zinc (400 U/g) neomycin sulfate (3.5 mg/g) polymyxin b sulfate (5000 U/g)

Linked Drug Pages (1)

triple antibiotic 01 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0e1b75c1-96b6-e939-e063-6394a90abffc", "openfda": {"unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["0e1b23f3-fa1e-f42b-e063-6394a90a3bec"], "manufacturer_name": ["Cosmuses Cosmetics (Ningbo) Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": ".9 g in 1 BAG (82953-013-01)", "package_ndc": "82953-013-01", "marketing_start_date": "20240104"}], "brand_name": "triple antibiotic 01", "product_id": "82953-013_0e1b75c1-96b6-e939-e063-6394a90abffc", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "82953-013", "generic_name": "Bacitracin Zinc, Neomycin sulfate, Polymyxin B sulfate", "labeler_name": "Cosmuses Cosmetics (Ningbo) Co., Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "triple antibiotic", "brand_name_suffix": "01", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "400 U/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "5000 U/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240104", "listing_expiration_date": "20261231"}