triple antibiotic with pain relief

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

Labeler: safetec of america, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name triple antibiotic with pain relief
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride
Labeler safetec of america, inc.
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 500 [iU]/g, neomycin sulfate 5 mg/g, polymyxin b sulfate 5000 [iU]/g, pramoxine hydrochloride 10 mg/g

Manufacturer
Safetec of America, Inc.

Identifiers & Regulatory

Product NDC 61010-4401
Product ID 61010-4401_118650cb-1aeb-b30a-e063-6394a90aff5a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2019-11-01

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 610104401
Hyphenated Format 61010-4401

Supplemental Identifiers

RxCUI
2055751
UNII
89Y4M234ES 057Y626693 19371312D4 88AYB867L5

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 with pain relief (source: ndc)
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 500 [iU]/g
  • 5 mg/g
  • 5000 [iU]/g
  • 10 mg/g
source: ndc
Packaging
  • 28.4 g in 1 TUBE (61010-4401-1)
source: ndc

Packages (1)

61010-4401-1 28.4 g in 1 TUBE (61010-4401-1)

Ingredients (4)

bacitracin zinc (500 [iU]/g) neomycin sulfate (5 mg/g) polymyxin b sulfate (5000 [iU]/g) pramoxine hydrochloride (10 mg/g)

Linked Drug Pages (1)

Triple Antibiotic with Pain Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "118650cb-1aeb-b30a-e063-6394a90aff5a", "openfda": {"unii": ["89Y4M234ES", "057Y626693", "19371312D4", "88AYB867L5"], "rxcui": ["2055751"], "spl_set_id": ["ca1df4a0-844d-4b1d-b972-f2704a8ebbab"], "manufacturer_name": ["Safetec of America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28.4 g in 1 TUBE (61010-4401-1)", "package_ndc": "61010-4401-1", "marketing_start_date": "20191101"}], "brand_name": "Triple Antibiotic with Pain Relief", "product_id": "61010-4401_118650cb-1aeb-b30a-e063-6394a90aff5a", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "61010-4401", "generic_name": "bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride", "labeler_name": "Safetec of America, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Triple Antibiotic with Pain Relief", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "500 [iU]/g"}, {"name": "NEOMYCIN SULFATE", "strength": "5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "5000 [iU]/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20191101", "listing_expiration_date": "20261231"}