first aid antibiotic plus burn relief

Generic: bacitracinzinc,neomycinsulfate,polymxinbsulfate,pramoxinehci

Labeler: trifecta pharmaceuticals usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name first aid antibiotic plus burn relief
Generic Name bacitracinzinc,neomycinsulfate,polymxinbsulfate,pramoxinehci
Labeler trifecta pharmaceuticals usa llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

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

Manufacturer
Trifecta Pharmaceuticals USA LLC

Identifiers & Regulatory

Product NDC 69396-138
Product ID 69396-138_298dae2b-f42d-53a1-e063-6394a90a223b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2023-09-04

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 69396138
Hyphenated Format 69396-138

Supplemental Identifiers

RxCUI
1359350
UPC
0850026393897
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 first aid antibiotic plus burn relief (source: ndc)
Generic Name bacitracinzinc,neomycinsulfate,polymxinbsulfate,pramoxinehci (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
  • 1 TUBE in 1 BOX (69396-138-02) / 57 g in 1 TUBE
source: ndc

Packages (1)

69396-138-02 1 TUBE in 1 BOX (69396-138-02) / 57 g in 1 TUBE

Ingredients (4)

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

Linked Drug Pages (1)

First Aid Antibiotic plus Burn Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "298dae2b-f42d-53a1-e063-6394a90a223b", "openfda": {"upc": ["0850026393897"], "unii": ["89Y4M234ES", "057Y626693", "19371312D4", "88AYB867L5"], "rxcui": ["1359350"], "spl_set_id": ["048871e2-c917-292d-e063-6394a90af130"], "manufacturer_name": ["Trifecta Pharmaceuticals USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (69396-138-02)  / 57 g in 1 TUBE", "package_ndc": "69396-138-02", "marketing_start_date": "20230904"}], "brand_name": "First Aid Antibiotic plus Burn Relief", "product_id": "69396-138_298dae2b-f42d-53a1-e063-6394a90a223b", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "69396-138", "generic_name": "Bacitracinzinc,NeomycinSulfate,PolymxinBSulfate,PramoxineHCI", "labeler_name": "Trifecta Pharmaceuticals USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "First Aid Antibiotic plus Burn Relief", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "500 [USP'U]/g"}, {"name": "NEOMYCIN SULFATE", "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": "20230904", "listing_expiration_date": "20261231"}