topcare triple antibiotic

Generic: bacitracin zinc, neomycin, polymyxin b

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topcare triple antibiotic
Generic Name bacitracin zinc, neomycin, polymyxin b
Labeler topco associates llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

bacitracin zinc 400 [USP'U]/g, neomycin sulfate 3.5 mg/g, polymyxin b sulfate 5000 [USP'U]/g

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-416
Product ID 36800-416_ad03114a-7d22-43d3-9e2f-dc62936cd5d1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2020-02-26

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 36800416
Hyphenated Format 36800-416

Supplemental Identifiers

RxCUI
204602
UNII
89Y4M234ES 057Y626693 19371312D4

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 topcare triple antibiotic (source: ndc)
Generic Name bacitracin zinc, neomycin, polymyxin b (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 400 [USP'U]/g
  • 3.5 mg/g
  • 5000 [USP'U]/g
source: ndc
Packaging
  • 2 TUBE in 1 CARTON (36800-416-26) / 56 g in 1 TUBE
  • 1 TUBE in 1 CARTON (36800-416-58) / 14.2 g in 1 TUBE
  • 1 TUBE in 1 CARTON (36800-416-64) / 28 g in 1 TUBE
source: ndc

Packages (3)

36800-416-26 2 TUBE in 1 CARTON (36800-416-26) / 56 g in 1 TUBE 36800-416-58 1 TUBE in 1 CARTON (36800-416-58) / 14.2 g in 1 TUBE 36800-416-64 1 TUBE in 1 CARTON (36800-416-64) / 28 g in 1 TUBE

Ingredients (3)

bacitracin zinc (400 [USP'U]/g) neomycin sulfate (3.5 mg/g) polymyxin b sulfate (5000 [USP'U]/g)

Linked Drug Pages (1)

topcare triple antibiotic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "ad03114a-7d22-43d3-9e2f-dc62936cd5d1", "openfda": {"unii": ["89Y4M234ES", "057Y626693", "19371312D4"], "rxcui": ["204602"], "spl_set_id": ["675665ee-bd0d-4168-81b8-341b1258c102"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TUBE in 1 CARTON (36800-416-26)  / 56 g in 1 TUBE", "package_ndc": "36800-416-26", "marketing_start_date": "20200226"}, {"sample": false, "description": "1 TUBE in 1 CARTON (36800-416-58)  / 14.2 g in 1 TUBE", "package_ndc": "36800-416-58", "marketing_start_date": "20200226"}, {"sample": false, "description": "1 TUBE in 1 CARTON (36800-416-64)  / 28 g in 1 TUBE", "package_ndc": "36800-416-64", "marketing_start_date": "20200226"}], "brand_name": "topcare triple antibiotic", "product_id": "36800-416_ad03114a-7d22-43d3-9e2f-dc62936cd5d1", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "36800-416", "generic_name": "bacitracin zinc, neomycin, polymyxin B", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare triple antibiotic", "active_ingredients": [{"name": "BACITRACIN ZINC", "strength": "400 [USP'U]/g"}, {"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "5000 [USP'U]/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200226", "listing_expiration_date": "20261231"}