triple antibiotic plus pain relief

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

Labeler: fred's, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name triple antibiotic plus pain relief
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride
Labeler fred's, inc.
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
FRED'S, INC.

Identifiers & Regulatory

Product NDC 55315-192
Product ID 55315-192_39fcb533-84b6-361f-e063-6294a90a94b6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2012-03-31

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 55315192
Hyphenated Format 55315-192

Supplemental Identifiers

RxCUI
1359350
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 plus pain relief (source: ndc)
Generic Name bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride (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 CARTON (55315-192-34) / 14.2 g in 1 TUBE
source: ndc

Packages (1)

55315-192-34 1 TUBE in 1 CARTON (55315-192-34) / 14.2 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)

Triple Antibiotic Plus Pain Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "39fcb533-84b6-361f-e063-6294a90a94b6", "openfda": {"unii": ["89Y4M234ES", "057Y626693", "19371312D4", "88AYB867L5"], "rxcui": ["1359350"], "spl_set_id": ["a44db5d1-7a74-44aa-9aa7-6247e771aaf2"], "manufacturer_name": ["FRED'S, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (55315-192-34)  / 14.2 g in 1 TUBE", "package_ndc": "55315-192-34", "marketing_start_date": "20190114"}], "brand_name": "Triple Antibiotic Plus Pain Relief", "product_id": "55315-192_39fcb533-84b6-361f-e063-6294a90a94b6", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "55315-192", "generic_name": "bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and pramoxine hydrochloride", "labeler_name": "FRED'S, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Triple Antibiotic", "brand_name_suffix": "Plus Pain 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": "20120331", "listing_expiration_date": "20261231"}