Topcare Antibiotic

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Topcare Antibiotic
Generic name: NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE
Manufacturer: Topco Associates LLC
Product type: HUMAN OTC DRUG
SPL set ID: 8c349cac-20e1-4600-9b0a-fcfe929551c5
SPL ID: cc235da2-c30c-4192-a5e7-5956c5981d72
Version: 4
Effective date: 2024-09-26
Source export date: 2026-10-12
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:10:18

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Topcare Antibiotic	openfda.brand_name
generic name		NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Topco Associates LLC	openfda.manufacturer_name
ndc	package	36800-976-58	openfda.package_ndc
ndc	product	36800-976	openfda.product_ndc
ndc11	package	36800097658	derived:openfda.package_ndc
rxcui		1359360	openfda.rxcui
spl id		cc235da2-c30c-4192-a5e7-5956c5981d72	id
spl set id		8c349cac-20e1-4600-9b0a-fcfe929551c5	set_id
unii		057Y626693	openfda.unii
unii		88AYB867L5	openfda.unii
unii		19371312D4	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. Do not use • if you are allergic to any of the ingredients • in the eyes • over large areas of the body Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • symptoms persist for more than 1 week, or clear up and occur again within a few days • rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.