thera plus original strength triple antibiotic

Generic: bacitracin zinc, neomycin sulfate, polymyxin b sulfate

Labeler: fourstar group usa, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name thera plus original strength triple antibiotic
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b sulfate
Labeler fourstar group usa, inc.
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
FOURSTAR GROUP USA, INC.

Identifiers & Regulatory

Product NDC 80684-140
Product ID 80684-140_3b3a56f2-a534-06b6-e063-6394a90a0a3c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2025-03-03

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 80684140
Hyphenated Format 80684-140

Supplemental Identifiers

RxCUI
204602
UPC
0049696700337
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 thera plus original strength triple antibiotic (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
  • 14 g in 1 TUBE (80684-140-00)
source: ndc

Packages (1)

80684-140-00 14 g in 1 TUBE (80684-140-00)

Ingredients (3)

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

Linked Drug Pages (1)

Thera Plus Original Strength Triple Antibiotic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3b3a56f2-a534-06b6-e063-6394a90a0a3c", "openfda": {"upc": ["0049696700337"], "unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["09e8bdb7-dc14-4f28-8306-c0e2bf73f081"], "manufacturer_name": ["FOURSTAR GROUP USA, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 g in 1 TUBE (80684-140-00)", "package_ndc": "80684-140-00", "marketing_start_date": "20250303"}], "brand_name": "Thera Plus Original Strength Triple Antibiotic", "product_id": "80684-140_3b3a56f2-a534-06b6-e063-6394a90a0a3c", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "80684-140", "generic_name": "BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE", "labeler_name": "FOURSTAR GROUP USA, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Thera Plus Original Strength Triple Antibiotic", "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": "20250303", "listing_expiration_date": "20261231"}