FDA.reportPublic FDA data

NDC 0591-2190-54 - Neomycin and Polymyxin B Sulfates

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0591-2190
Requested NDC
0591-2190-54
Package NDCs from labels
0591-2190-54, 0591-2190-45, 0591-2190-50
Manufacturer
Actavis Pharma, Inc.
Effective date
2017-12-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Neomycin and Polymyxin B Sulfates - Actavis Pharma, Inc.Actavis Pharma, Inc.2017-12-21HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2190-45ML - Milliliter0591-21905cd30a3a-8baf-4804-aa2d-c3f03f2659e412012-07-24
0591-2190-50ML - Milliliter0591-2190651ab705-aae1-4fcb-96b5-c374ed80c65812012-07-24
0591-2190-54ML - Milliliter0591-219095378bee-1cea-46e2-a53d-1393c8bf791e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693NEOMYCIN AND POLYMYXIN B SULFATES IRRIGANT [WATSON LABORATORIES, INC.]9
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4NEOMYCIN AND POLYMYXIN B SULFATES IRRIGANT [WATSON LABORATORIES, INC.]9
NEOMYCINACTIVE MOIETYI16QD7X297NEOMYCIN AND POLYMYXIN B SULFATES IRRIGANT [WATSON LABORATORIES, INC.]9
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KNEOMYCIN AND POLYMYXIN B SULFATES IRRIGANT [WATSON LABORATORIES, INC.]9
WATERINACTIVE INGREDIENT059QF0KO0RNEOMYCIN AND POLYMYXIN B SULFATES IRRIGANT [WATSON LABORATORIES, INC.]9

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 1 of 28 · 548 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
polymyxin b sulfate and trimethoprim sulfatePOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEREMEDYREPACK INC.c68818b2-d849-41d2-be07-731244afbbac2026-09-09Warnings, Adverse reactionsExact identifier
unii: 19371312D4
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATENuCare Pharmaceutical, Inc.5b14499e-e45c-7c05-e063-6294a90a1cc22026-09-09WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0df2da-1688-c477-e053-2995a90a74a22026-09-07WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0d108f-42bf-3364-e053-2a95a90a45422026-09-07WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4d0a4-b90c-99b0-e053-2995a90ab4232026-09-04WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Lil Drug Store Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INCe6e5263b-328f-4775-9fac-34302f050ce02026-09-04WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e42c5c-e080-4efb-e053-2a95a90af52e2026-09-04WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4854a-ee01-df72-e053-2995a90aa8ea2026-09-04WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Circle K Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INC84c3f7e4-b28b-40bb-8d9d-7c8d679e3a3a2026-09-04WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLWalgreen Companyb982091a-5aa0-4bbc-bb1d-08016f6d0a702026-09-03WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
SurviveX Triple AntibioticTRIPLE ANTIBIOTICNantong Health & Beyond Hygienic Products Inc.5a7cb52d-a60c-b947-e063-6394a90afb0d2026-09-02WarningsExact identifier
unii: 057Y626693
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BWalgreen Company4f3cfe39-2df8-48b4-954d-5997217c92ba2026-08-31WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
First Aid AntibioticBACITRACIN ZINCNINGBO TIANBO FIRST AID PRODUCT CO., LTD.217aa2b8-94f5-468a-99b4-52824a77b5732026-08-28WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
OP Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEYiwu Ori-Power Medtech Co., Ltd.03f3cce9-7e9f-90a6-e063-6294a90a660b2026-08-28WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Be Smart Get Prepared Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETotal Resources International, Inc57ed1a03-7e1b-4eb4-8001-dfd118805edc2026-08-24WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ClaravieBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN BGentell LLC597cb2f0-ff05-a1ab-e063-6294a90acda92026-08-20WarningsExact identifier
unii: 057Y626693
Medpride First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEShield Line LLC5ba3e703-7873-4724-a0bf-bb22d8a257482026-08-18WarningsExact identifier
unii: 057Y626693
unii: 19371312D4
First Aid Antibiotic and Burn ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEAmazon.com Services LLC3459a453-0a94-4122-adad-bb120daecd9e2026-08-18WarningsExact identifier
unii: 057Y626693
unii: 19371312D4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.