Triple Antibiotic Plus

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 Plus
Generic name: POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCL
Manufacturer: Cosette Pharmaceuticals, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 69d911c2-cb89-2241-35f8-c83acfe18249
SPL ID: bbe9b82b-867d-4f19-8948-bcc36695092c
Version: 5
Effective date: 2023-12-21
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:19:34

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M004	openfda.application_number
brand name		Triple Antibiotic Plus	openfda.brand_name
generic name		POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCL	openfda.generic_name
manufacturer name		Cosette Pharmaceuticals, Inc.	openfda.manufacturer_name
ndc	package	0713-0622-31	openfda.package_ndc
ndc	product	0713-0622	openfda.product_ndc
ndc11	package	00713062231	derived:openfda.package_ndc
rxcui		1359350	openfda.rxcui
spl id		bbe9b82b-867d-4f19-8948-bcc36695092c	id
spl set id		69d911c2-cb89-2241-35f8-c83acfe18249	set_id
unii		89Y4M234ES	openfda.unii
unii		I16QD7X297	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 longer than 1 week unless directed by a doctor. Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if the condition persists or gets worse symptoms persist for more than 1 week, or clear up and occur again within a few days a rash or other allergic reaction develops

Reported adverse events (FAERS/openFDA)#

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