triple antibiotic plus pain relief

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

Labeler: genomma lab usa, 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 genomma lab usa, 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
GENOMMA LAB USA, INC.

Identifiers & Regulatory

Product NDC 50066-202
Product ID 50066-202_38f62d88-9504-c0a2-e063-6294a90a12c0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2023-12-21

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 50066202
Hyphenated Format 50066-202

Supplemental Identifiers

RxCUI
1359350
UPC
0650240070655
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 (50066-202-01) / 28.4 g in 1 TUBE
source: ndc

Packages (1)

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)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "38f62d88-9504-c0a2-e063-6294a90a12c0", "openfda": {"upc": ["0650240070655"], "unii": ["89Y4M234ES", "057Y626693", "19371312D4", "88AYB867L5"], "rxcui": ["1359350"], "spl_set_id": ["506fcda5-df44-49c8-8dbd-cab7434b06b2"], "manufacturer_name": ["GENOMMA LAB USA, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (50066-202-01)  / 28.4 g in 1 TUBE", "package_ndc": "50066-202-01", "marketing_start_date": "20231221"}], "brand_name": "TRIPLE ANTIBIOTIC PLUS PAIN RELIEF", "product_id": "50066-202_38f62d88-9504-c0a2-e063-6294a90a12c0", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "50066-202", "generic_name": "Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride", "labeler_name": "GENOMMA LAB USA, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TRIPLE ANTIBIOTIC 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": "20231221", "listing_expiration_date": "20261231"}