triple antibiotic plus

Generic: polymyxin b sulfate, bacitracin zinc, neomycin sulfate, pramoxine hcl

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name triple antibiotic plus
Generic Name polymyxin b sulfate, bacitracin zinc, neomycin sulfate, pramoxine hcl
Labeler cosette pharmaceuticals, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 500 [USP'U]/g, neomycin 3.5 mg/g, polymyxin b sulfate 10000 [USP'U]/g, pramoxine hydrochloride 10 mg/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0622
Product ID 0713-0622_bbe9b82b-867d-4f19-8948-bcc36695092c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 1998-02-28

Pharmacologic Class

Established (EPC)
aminoglycoside antibacterial [epc]
Chemical Structure
aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130622
Hyphenated Format 0713-0622

Supplemental Identifiers

RxCUI
1359350
UNII
89Y4M234ES I16QD7X297 19371312D4 88AYB867L5
NUI
N0000175477 M0000946

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 plus (source: ndc)
Generic Name polymyxin b sulfate, bacitracin zinc, neomycin sulfate, pramoxine hcl (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 500 [USP'U]/g
  • 3.5 mg/g
  • 10000 [USP'U]/g
  • 10 mg/g
source: ndc
Packaging
  • 28.4 g in 1 TUBE (0713-0622-31)
source: ndc

Packages (1)

0713-0622-31 28.4 g in 1 TUBE (0713-0622-31)

Ingredients (4)

bacitracin zinc (500 [USP'U]/g) neomycin (3.5 mg/g) polymyxin b sulfate (10000 [USP'U]/g) pramoxine hydrochloride (10 mg/g)

Linked Drug Pages (1)

Triple Antibiotic Plus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "bbe9b82b-867d-4f19-8948-bcc36695092c", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["89Y4M234ES", "I16QD7X297", "19371312D4", "88AYB867L5"], "rxcui": ["1359350"], "spl_set_id": ["69d911c2-cb89-2241-35f8-c83acfe18249"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28.4 g in 1 TUBE (0713-0622-31)", "package_ndc": "0713-0622-31", "marketing_start_date": "19980228"}], "brand_name": "Triple Antibiotic Plus", "product_id": "0713-0622_bbe9b82b-867d-4f19-8948-bcc36695092c", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "0713-0622", "generic_name": "Polymyxin B Sulfate, Bacitracin Zinc, Neomycin Sulfate, Pramoxine HCl", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Triple Antibiotic Plus", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "500 [USP'U]/g"}, {"name": "NEOMYCIN", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19980228", "listing_expiration_date": "20261231"}