Home NDC 54312-019 VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC
Product NDC 54312-019
11-digit product format 543120019
Labeler code 54312
Product ID 54312-019_43fa588f-3f99-7492-e063-6294a90a5954
Type HUMAN OTC DRUG
Nonproprietary name NEOMYCIN SULFATE
Dosage form OINTMENT
Route TOPICAL
Labeler Compania Internacional de Comercio, S.A.P.I de C.V.
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-07-30
Substance NEOMYCIN SULFATE
Active strength 3.5 mg/g
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [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 VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEOMYCIN SULFATE 3.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1544556 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 54312-019-31 VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC 28 g in 1 TUBE OINTMENT 28 22 54312-019-31 VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC 1 in 1 CARTON OINTMENT 1 22 54312-019-35 VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC 14 g in 1 TUBE OINTMENT 14 22 54312-019-35 VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC 1 in 1 CARTON OINTMENT 1 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54312-019 VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A.P.I DE C.V.] 19 Current NDC, Legacy NDC, 4 package rows 20241219_ba7a3331-466e-496f-bebd-9ee7067bcdb2.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 54312-019-31 54312001931 1 TUBE in 1 CARTON (54312-019-31) / 28 g in 1 TUBE 1 tube 2016-07-30 0000-00-00 No No Current 54312-019-35 54312001935 1 TUBE in 1 CARTON (54312-019-35) / 14 g in 1 TUBE 1 tube 2016-07-30 0000-00-00 No No Current