Home NDC 58228-2261 PS-2261 Triple Antibiotic, 0.5g
Product NDC 58228-2261
11-digit product format 582282261
Labeler code 58228
Product ID 58228-2261_46013412-e449-b632-e063-6394a90a0b04
Type HUMAN OTC DRUG
Nonproprietary name PS-2261 Triple Antibiotic, 0.5g
Dosage form OINTMENT
Route TOPICAL
Labeler ProStat First Aid LLC
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-31
Substance POLYMYXIN B SULFATE; BACITRACIN ZINC; NEOMYCIN SULFATE
Active strength 5000; 400; 5 [iU]/g; [iU]/g; mg/g
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base PS-2261 Triple Antibiotic, 0.5g
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYMYXIN B SULFATE 5000 [iU]/g BACITRACIN ZINC 400 [iU]/g NEOMYCIN SULFATE 5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 19371312D4 Internal UNII lookup 89Y4M234ES Internal UNII lookup 057Y626693 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204602 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58228-2261-1 PS-2261 Triple Antibiotic, 0.5g 10 in 1 BOX OINTMENT 10 3 58228-2261-1 PS-2261 Triple Antibiotic, 0.5g 1000 in 1 CARTON OINTMENT 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58228-2261 PS-2261 TRIPLE ANTIBIOTIC, 0.5G OINTMENT [PROSTAT FIRST AID LLC] 2 Current NDC, 2 package rows 20241127_0072f8de-fc06-d529-e063-6294a90a08db.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 22 of 22 · 421 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cuadriderma BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE ProMex LLC 4fa99b96-ab4b-4523-82bc-343dbaf39fb6 2022-01-25 Warnings Exact identifier application number: M004
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58228-2261-1 58228226101 1000 BOX in 1 CARTON (58228-2261-1) / 10 PACKET in 1 BOX / .5 g in 1 PACKET 1000 box 2023-07-31 No No Current