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: Safetec of America, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 59494d5c-dd8a-431c-8e6a-4e1151ba7460
SPL ID: 10aa746d-d831-277b-e063-6294a90ac9b8
Version: 2
Effective date: 2024-02-05
Source export date: 2026-10-12
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:25:15

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		Safetec of America, Inc.	openfda.manufacturer_name
ndc	package	61010-4400-2	openfda.package_ndc
ndc	product	61010-4400	openfda.product_ndc
ndc11	package	61010440002	derived:openfda.package_ndc
rxcui		204602	openfda.rxcui
spl id		10aa746d-d831-277b-e063-6294a90ac9b8	id
spl set id		59494d5c-dd8a-431c-8e6a-4e1151ba7460	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 internally in eyes over large areas of the body or on puncture wounds, animal bites or serious burns for more than 1 week unless directed by a doctor if you are allergic to any of the ingredients Stop use and ask a doctor if a rash or allergic reaction develops condition worsens or persists Keep out of reach of children If ingested, contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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