Home NDC 61010-5600 Triple Antibiotic
Product NDC 61010-5600
11-digit product format 610105600
Labeler code 61010
Product ID 61010-5600_10d3b150-077e-cb76-e063-6394a90ab356
Type HUMAN OTC DRUG
Nonproprietary name bacitracin zinc, neomycin sulfate, polymyxin b sulfate
Dosage form OINTMENT
Route TOPICAL
Labeler Safetec of America, Inc.
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-08-08
Substance BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/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 [USP'U]/g NEOMYCIN SULFATE 3.5 mg/g POLYMYXIN B SULFATE 5000 [USP'U]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 89Y4M234ES Internal UNII lookup 057Y626693 Internal UNII lookup 19371312D4 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 61010-5600-1 2024-02-13 61010-5600, Triple Antibiotic Ointment 61010-5600-2 2024-02-13 61010-5600, Triple Antibiotic Ointment 61010-5600-3 2024-02-13 61010-5600, Triple Antibiotic Ointment 61010-5600-4 2024-02-13 61010-5600, Triple Antibiotic Ointment 61010-5600-1 2024-01-30 61010-5600, Triple Antibiotic Ointment 61010-5600-2 2024-01-30 61010-5600, Triple Antibiotic Ointment 61010-5600-3 2024-01-30 61010-5600, Triple Antibiotic Ointment 61010-5600-4 2024-01-30 61010-5600, Triple Antibiotic Ointment
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-5600-1 Triple Antibiotic 0.9 g in 1 POUCH OINTMENT 0.9 6 61010-5600-2 Triple Antibiotic 144 in 1 BOX OINTMENT 144 6 61010-5600-2 Triple Antibiotic 0.9 g in 1 POUCH OINTMENT 0.9 6 61010-5600-3 Triple Antibiotic 25 in 1 BOX OINTMENT 25 6 61010-5600-3 Triple Antibiotic 0.9 g in 1 POUCH OINTMENT 0.9 6 61010-5600-4 Triple Antibiotic 10 in 1 BOX OINTMENT 10 6 61010-5600-4 Triple Antibiotic 0.9 g in 1 PACKET OINTMENT 0.9 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded bacitracin zinc ACTIVE INGREDIENT 89Y4M234ES TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.] 1 neomycin sulfate ACTIVE INGREDIENT 057Y626693 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.] 1 polymyxin b sulfate ACTIVE INGREDIENT 19371312D4 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.] 1 bacitracin zinc ACTIVE MOIETY 89Y4M234ES TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.] 1 neomycin ACTIVE MOIETY I16QD7X297 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.] 1 polymyxin b ACTIVE MOIETY J2VZ07J96K TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.] 1 petrolatum INACTIVE INGREDIENT 4T6H12BN9U TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-5600 TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [SAFETEC OF AMERICA, INC.] 6 Current NDC, Legacy NDC, 7 package rows 20240214_96c41fc1-81f9-4757-abc6-867b5383ed5d.zip 61010-5600 CARE SCIENCE ESSENTIAL FIRST AID (ETHYL ALCOHOL, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE) KIT [ASO LLC] 3 Current NDC, Legacy NDC 20240830_4e53fc6b-4774-4224-8759-eadd150ff959.zip 61010-5600 CARE SCIENCE OSHA FIRST AID (ETHYL ALCOHOL, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN-B SULFATE, DIPHENHYDRAMINE HYDROCHLORIDE, HYDROCORTISONE, IBUPROFEN, ACETAMINOPHEN, WATER) KIT [ASO LLC] 2 Current NDC, Legacy NDC 20241107_1cbace4d-fd0a-41d1-aa71-907d43620bf8.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 61010-5600-1 61010560001 .9 g in 1 POUCH (61010-5600-1) 2011-08-08 0000-00-00 No No Current 61010-5600-2 61010560002 144 POUCH in 1 BOX (61010-5600-2) / .9 g in 1 POUCH 144 pouch 2011-08-08 0000-00-00 No No Current 61010-5600-3 61010560003 25 POUCH in 1 BOX (61010-5600-3) / .9 g in 1 POUCH 25 pouch 2011-08-08 0000-00-00 No No Current 61010-5600-4 61010560004 10 PACKET in 1 BOX (61010-5600-4) / .9 g in 1 PACKET 10 packet 2020-04-01 0000-00-00 No No Current