Home NDC 55315-180 Triple Antibiotic
Product NDC 55315-180
11-digit product format 553150180
Labeler code 55315
Product ID 55315-180_39fb9892-fd98-37e2-e063-6394a90adb6e
Type HUMAN OTC DRUG
Nonproprietary name Bacitracin Zinc, Neomycin Sulfate, and POLYMYXIN B SULFATE
Dosage form OINTMENT
Route TOPICAL
Labeler Fred's, Inc.
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-11-15
Substance BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength 400; 3.5; 5000 [iU]/g; mg/g; [iU]/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 Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N000004-004 PAREDRINE HYDROXYAMPHETAMINE HYDROBROMIDE 1% SOLUTION/DROPS / OPHTHALMIC Approved before 1982
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Triple Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE Fred's, Inc. 41ee7a50-d36b-4214-b6f8-44f47ab44a84 2025-07-15 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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 Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if you need to use longer than 1 week condition persists or gets worse rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Additional Listing Data#
Finished product Yes
Brand name base Triple Antibiotic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 400 [iU]/g NEOMYCIN SULFATE 3.5 mg/g POLYMYXIN B SULFATE 5000 [iU]/g
Harmonized Identifiers# Field, Values table Field Values Unii 89Y4M234ES, 057Y626693, 19371312D4 Rxcui 204602
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55315-180-56 Triple Antibiotic 1 in 1 CARTON OINTMENT 1 3 55315-180-56 Triple Antibiotic 28.4 g in 1 TUBE OINTMENT 28.4 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55315-180 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [FRED'S, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20241109_41ee7a50-d36b-4214-b6f8-44f47ab44a84.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55315-180-56 55315018056 1 TUBE in 1 CARTON (55315-180-56) / 28.4 g in 1 TUBE 1 tube 2018-11-15 0000-00-00 No No Current