Triple 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: Triple Antibiotic
Generic name: BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.
Manufacturer: TRIFECTA PHARMACEUTICALS USA LLC
Product type: HUMAN OTC DRUG
SPL set ID: 4124e9e2-397f-8921-e063-6394a90a5ffe
SPL ID: 4124eb7b-bb0c-8835-e063-6394a90ad97d
Version: 1
Effective date: 2025-10-14
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:14:48

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		M004	openfda.application_number
brand name		Triple Antibiotic	openfda.brand_name
generic name		BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	openfda.generic_name
manufacturer name		TRIFECTA PHARMACEUTICALS USA LLC	openfda.manufacturer_name
ndc	package	69396-162-09	openfda.package_ndc
ndc	product	69396-162	openfda.product_ndc
ndc11	package	69396016209	derived:openfda.package_ndc
rxcui		204602	openfda.rxcui
spl id		4124eb7b-bb0c-8835-e063-6394a90ad97d	id
spl set id		4124e9e2-397f-8921-e063-6394a90a5ffe	set_id
unii		89Y4M234ES	openfda.unii
unii		057Y626693	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 ● in the eyes ● over large areas of the body ● if you are allergic to any of the ingredients. Ask a doctor before use if you have ● deep or puncture wounds ● animal bites ● serious burns. Stop use and ask a doctor if ● condition persists or gets worse ● you need to use longer than 1 week ● a rash or other allergic reaction develops

Reported adverse events (FAERS/openFDA)#

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