Thera Plus Original Strength 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: Thera Plus Original Strength Triple Antibiotic
Generic name: BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Manufacturer: FOURSTAR GROUP USA, INC.
Product type: HUMAN OTC DRUG
SPL set ID: 09e8bdb7-dc14-4f28-8306-c0e2bf73f081
SPL ID: 3b3a56f2-a534-06b6-e063-6394a90a0a3c
Version: 4
Effective date: 2025-07-31
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:19:13

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		Thera Plus Original Strength Triple Antibiotic	openfda.brand_name
generic name		BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	openfda.generic_name
manufacturer name		FOURSTAR GROUP USA, INC.	openfda.manufacturer_name
ndc	package	80684-140-00	openfda.package_ndc
ndc	product	80684-140	openfda.product_ndc
ndc11	package	80684014000	derived:openfda.package_ndc
rxcui		204602	openfda.rxcui
spl id		3b3a56f2-a534-06b6-e063-6394a90a0a3c	id
spl set id		09e8bdb7-dc14-4f28-8306-c0e2bf73f081	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 if you are allergic to any of the ingredients in this product in contact with the eyes or mucous membranes over large areas of the body longer than 1 week unless directed by a doctor When using this product avoid contact with eyes Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if symptoms last for more than 7 days the condition persists or gets worse symptoms clear up and then occur again within a few days a rash or other allergic reaction occurs 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.