Home NDC 46122-414 Triple Antibiotic
Product NDC 46122-414
11-digit product format 461220414
Labeler code 46122
Product ID 46122-414_5c53008d-8fa0-e51f-e063-6294a90a8846
Type HUMAN OTC DRUG
Nonproprietary name Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Dosage form OINTMENT
Route TOPICAL
Labeler AmerisourceBergen
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-12-15
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 2027-12-31
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 Triple Antibiotic
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 400 [iU]/g NEOMYCIN SULFATE 3.5 mg/g POLYMYXIN B SULFATE 5000 [iU]/g
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46122-414-03 Triple Antibiotic 28.4 g in 1 TUBE OINTMENT 28.4 4 46122-414-03 Triple Antibiotic 1 in 1 CARTON OINTMENT 1 4 46122-414-05 Triple Antibiotic 1 in 1 CARTON OINTMENT 1 4 46122-414-05 Triple Antibiotic 14.2 g in 1 TUBE OINTMENT 14.2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46122-414 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE) OINTMENT [AMERISOURCEBERGEN] 3 Current NDC, Legacy NDC, 4 package rows 20241109_f3c9b5cf-790a-46c6-94eb-4f866deac1e5.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 · 424 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Family Wellness Antiseptic and Pain Relief BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE FRONT PHARMACEUTICAL PLC cb7fdcde-2bd8-4834-ba4e-4d6fd1512599 2023-10-26 Warnings Exact identifier application number: M004 GENUINE FIRST AID Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Nantong Health & Beyond Hygienic Products Inc. 23abfe12-5b50-4b49-878e-4fcdb6c341fd 2023-10-19 Warnings Exact identifier application number: M004 EVERLIT CARE Triple Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Nantong Health & Beyond Hygienic Products Inc. f4921508-c32f-426f-a2f0-16c3acbd4713 2023-10-14 Warnings Exact identifier application number: M004 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 Marketing end Sample Exclude flag Status 46122-414-03 46122041403 1 TUBE in 1 CARTON (46122-414-03) / 28.4 g in 1 TUBE 1 tube 2017-04-04 0000-00-00 No No Current 46122-414-05 46122041405 1 TUBE in 1 CARTON (46122-414-05) / 14.2 g in 1 TUBE 1 tube 2017-04-04 0000-00-00 No No Current