topcare triple antibiotic

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

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, pramoxine hydrochloride
Labeler topco associates 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
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-780
Product ID 36800-780_05358cf0-75b2-4ea0-af54-5aaba75c8923
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2020-03-15

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 36800780
Hyphenated Format 36800-780

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 topcare triple antibiotic (source: ndc)
Generic Name bacitracin zinc, neomycin, polymyxin b, 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 (36800-780-64) / 28 g in 1 TUBE
source: ndc

Packages (1)

36800-780-64 1 TUBE in 1 CARTON (36800-780-64) / 28 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)

topcare triple antibiotic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "05358cf0-75b2-4ea0-af54-5aaba75c8923", "openfda": {"unii": ["89Y4M234ES", "057Y626693", "19371312D4", "88AYB867L5"], "rxcui": ["1359350"], "spl_set_id": ["5e0fc39b-e6d4-4543-8afc-2881e2f85f9b"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (36800-780-64)  / 28 g in 1 TUBE", "package_ndc": "36800-780-64", "marketing_start_date": "20200315"}], "brand_name": "topcare triple antibiotic", "product_id": "36800-780_05358cf0-75b2-4ea0-af54-5aaba75c8923", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Decreased Cell Wall Synthesis & Repair [PE]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "36800-780", "generic_name": "bacitracin zinc, neomycin, polymyxin B, pramoxine hydrochloride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare triple antibiotic", "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": "20200315", "listing_expiration_date": "20261231"}