tripleantibioticointmentandpainrelief

Generic: family wellness bacitracin,neomycin,polymyxinb,pramoxine

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

Drug Facts

Product Profile

Brand Name tripleantibioticointmentandpainrelief
Generic Name family wellness bacitracin,neomycin,polymyxinb,pramoxine
Labeler trifecta pharmaceutical usa llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin 500 [USP'U]/100g, neomycin sulfate 3.5 mg/100g, polymyxin b sulfate 10000 [USP'U]/100g, pramoxine hydrochloride 10 mg/100g

Manufacturer
Trifecta Pharmaceutical USA LLC

Identifiers & Regulatory

Product NDC 69396-044
Product ID 69396-044_29b3e33a-544c-40b4-e063-6394a90a1107
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2019-08-30

Pharmacologic Class

Physiologic Effect
decreased cell wall synthesis & repair [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69396044
Hyphenated Format 69396-044

Supplemental Identifiers

RxCUI
1359350
UPC
0032251533129
UNII
58H6RWO52I 057Y626693 19371312D4 88AYB867L5
NUI
N0000008479

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 tripleantibioticointmentandpainrelief (source: ndc)
Generic Name family wellness bacitracin,neomycin,polymyxinb,pramoxine (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 500 [USP'U]/100g
  • 3.5 mg/100g
  • 10000 [USP'U]/100g
  • 10 mg/100g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (69396-044-01) / 28.4 g in 1 TUBE
source: ndc

Packages (1)

69396-044-01 1 TUBE in 1 BOX (69396-044-01) / 28.4 g in 1 TUBE

Ingredients (4)

bacitracin (500 [USP'U]/100g) neomycin sulfate (3.5 mg/100g) polymyxin b sulfate (10000 [USP'U]/100g) pramoxine hydrochloride (10 mg/100g)

Linked Drug Pages (1)

Tripleantibioticointmentandpainrelief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "29b3e33a-544c-40b4-e063-6394a90a1107", "openfda": {"nui": ["N0000008479"], "upc": ["0032251533129"], "unii": ["58H6RWO52I", "057Y626693", "19371312D4", "88AYB867L5"], "rxcui": ["1359350"], "spl_set_id": ["91575333-5268-5d8f-e053-2a95a90a7a89"], "pharm_class_pe": ["Decreased Cell Wall Synthesis & Repair [PE]"], "manufacturer_name": ["Trifecta Pharmaceutical USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (69396-044-01)  / 28.4 g in 1 TUBE", "package_ndc": "69396-044-01", "marketing_start_date": "20190922"}], "brand_name": "Tripleantibioticointmentandpainrelief", "product_id": "69396-044_29b3e33a-544c-40b4-e063-6394a90a1107", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "69396-044", "generic_name": "Family Wellness Bacitracin,Neomycin,PolymyxinB,Pramoxine", "labeler_name": "Trifecta Pharmaceutical USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tripleantibioticointmentandpainrelief", "active_ingredients": [{"name": "BACITRACIN", "strength": "500 [USP'U]/100g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/100g"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/100g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/100g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190830", "listing_expiration_date": "20261231"}