topcare antibiotic

Generic: 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 antibiotic
Generic Name neomycin, polymyxin b, pramoxine hydrochloride
Labeler topco associates llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

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 36800-976
Product ID 36800-976_cc235da2-c30c-4192-a5e7-5956c5981d72
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2020-04-03

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs] polymyxin-class antibacterial [epc] polymyxins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800976
Hyphenated Format 36800-976

Supplemental Identifiers

RxCUI
1359360
UNII
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 antibiotic (source: ndc)
Generic Name neomycin, polymyxin b, pramoxine hydrochloride (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/g
  • 10000 [USP'U]/g
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (36800-976-58) / 14 g in 1 TUBE
source: ndc

Packages (1)

36800-976-58 1 TUBE in 1 CARTON (36800-976-58) / 14 g in 1 TUBE

Ingredients (3)

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

Linked Drug Pages (1)

Topcare Antibiotic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "cc235da2-c30c-4192-a5e7-5956c5981d72", "openfda": {"unii": ["057Y626693", "19371312D4", "88AYB867L5"], "rxcui": ["1359360"], "spl_set_id": ["8c349cac-20e1-4600-9b0a-fcfe929551c5"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (36800-976-58)  / 14 g in 1 TUBE", "package_ndc": "36800-976-58", "marketing_start_date": "20200403"}], "brand_name": "Topcare Antibiotic", "product_id": "36800-976_cc235da2-c30c-4192-a5e7-5956c5981d72", "dosage_form": "CREAM", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "36800-976", "generic_name": "neomycin, polymyxin B, pramoxine hydrochloride", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare Antibiotic", "active_ingredients": [{"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": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200403", "listing_expiration_date": "20261231"}