Home NDC 49348-600 sunmark
Product NDC 49348-600
11-digit product format 493480600
Labeler code 49348
Product ID 49348-600_39fd0345-f7e8-70ae-e063-6294a90a45c3
Type HUMAN OTC DRUG
Nonproprietary name polymyxin B sulfate, bacitracin zinc, neomycin sulfate, and pramoxine hydrochloride
Dosage form OINTMENT
Route TOPICAL
Labeler Strategic Sourcing Services LLC
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-03-31
Marketing end 2027-08-31
Substance BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength 500; 3.5; 10000; 10 [iU]/g; mg/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
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 sunmark
Brand name suffix triple antibiotic plus pain relief Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 500 [iU]/g NEOMYCIN SULFATE 3.5 mg/g POLYMYXIN B SULFATE 10000 [iU]/g PRAMOXINE HYDROCHLORIDE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1359350 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 49348-600-72 sunmarktriple antibiotic plus pain relief 1 in 1 CARTON OINTMENT 1 4 49348-600-72 sunmarktriple antibiotic plus pain relief 28.4 g in 1 TUBE OINTMENT 28.4 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BACITRACIN ZINC ACTIVE INGREDIENT 89Y4M234ES SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON] 1 NEOMYCIN SULFATE ACTIVE INGREDIENT 057Y626693 SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON] 1 POLYMYXIN B SULFATE ACTIVE INGREDIENT 19371312D4 SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON] 1 PRAMOXINE HYDROCHLORIDE ACTIVE INGREDIENT 88AYB867L5 SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON] 1 BACITRACIN ACTIVE MOIETY 58H6RWO52I SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON] 1 NEOMYCIN ACTIVE MOIETY I16QD7X297 SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON] 1 POLYMYXIN B ACTIVE MOIETY J2VZ07J96K SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON] 1 PRAMOXINE ACTIVE MOIETY 068X84E056 SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [MCKESSON] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49348-600 SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [STRATEGIC SOURCING SERVICES LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241006_941a6a71-e898-4af3-989a-6d3aa3224338.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 49348-600-72 49348060072 1 TUBE in 1 CARTON (49348-600-72) / 28.4 g in 1 TUBE 1 tube 2013-02-13 2027-08-31 No No Current