FDA.reportPublic FDA data

NDC 60816-2340 - Wiley Spinal 199-2340

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
60816-2340
Package NDCs from labels
60816-2340-1
Manufacturer
Epimed International | Aplicare, Inc.
Effective date
2013-09-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Wiley Spinal 199-2340 - Epimed International | Aplicare, Inc.Epimed International | Aplicare, Inc.2013-09-30MEDICAL DEVICE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60816-2340-1Wiley Spinal199-23401 in 1 PACKAGEKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60816-2340WILEY SPINAL 199-2340 () KIT [EPIMED INTERNATIONAL]11 package rows20131001_2ddbb193-4e4f-4ff5-bac1-41d7b8e91260.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Povidone-iodineACTIVE INGREDIENT85H0HZU99MWILEY SPINAL 199-2340 () KIT [EPIMED INTERNATIONAL]1
IODINEACTIVE MOIETY9679TC07X4WILEY SPINAL 199-2340 () KIT [EPIMED INTERNATIONAL]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPWILEY SPINAL 199-2340 () KIT [EPIMED INTERNATIONAL]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TWILEY SPINAL 199-2340 () KIT [EPIMED INTERNATIONAL]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IWILEY SPINAL 199-2340 () KIT [EPIMED INTERNATIONAL]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74WILEY SPINAL 199-2340 () KIT [EPIMED INTERNATIONAL]1
WATERINACTIVE INGREDIENT059QF0KO0RWILEY SPINAL 199-2340 () KIT [EPIMED INTERNATIONAL]1

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 10 of 25 · 484 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Povidone Iodine PrepPOVIDONE IODINEPHOENIX HEALTHCARE SOLUTIONS, LLCc17603f2-3548-4225-b611-216c2763e51f2025-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone Iodine Prep SwabstickPOVIDONE IODINEPHOENIX HEALTHCARE SOLUTIONS, LLC8a0aba34-3f96-46b6-8521-f4388fb73edf2025-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine Prep Pads MediumPOVIDONE-IODINEMedline Industries, LP28c05c5c-09d3-2c62-e054-00144ff8d46c2025-10-23WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine Swabsticks SinglesPOVIDONE-IODINEMedline Industries, LP28c26a44-0699-4fa5-e054-00144ff88e882025-10-23WarningsExact identifier
unii: 85H0HZU99M
PROHEAL POVIDONE IODINE PREP PADSPOVIDONE-IODINEClick Industries LLC53733b6c-fa62-43e0-bfcc-3d23b5e1a95a2025-10-23WarningsExact identifier
unii: 85H0HZU99M
POVIDONE-IODINEPOVIDONE-IODINEJames Alexander Corporation181a6363-2249-45f0-a28b-79f2c5ffad592025-10-23WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
Povidone-IodinePOVIDONE-IODINEMedline Industries, LP2b95078e-2caf-7005-e054-00144ff88e882025-10-22WarningsExact identifier
unii: 85H0HZU99M
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
equate First Aid AntisepticPOVIDONE-IODINEWalmart Inc.43bbedec-be30-482a-8552-949b13d4bea12025-10-14WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
MediChoice Povidone-Iodine Prep PadPOVIDONE-IODINEO&M HALYARD, INC.00bfdd07-af21-4b01-81fb-c89deea332882025-10-09WarningsExact identifier
unii: 85H0HZU99M
Povidone-Iodine PrepPOVIDONE-IODINEO&M HALYARD, INC.f3e0af11-39b6-44a0-8f84-a4b36631e8f02025-10-09WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M
MediChoice PVPPOVIDONE-IODINEO&M HALYARD, INC.04e9b3e7-2505-48c4-96a5-eb8eb2d1625e2025-10-09WarningsExact identifier
unii: 85H0HZU99M
MediChoice PVPPOVIDONE-IODINEO&M HALYARD, INC.63c6d510-5869-4416-96b9-5c4fb27e8c362025-10-09WarningsExact identifier
unii: 85H0HZU99M
MediChoice Povidone-IodinePOVIDONE-IODINEO&M HALYARD, INC.959332db-d522-450b-b09e-be6a998899db2025-10-09WarningsExact identifier
unii: 85H0HZU99M
MediChoice PVP PrepPOVIDONE-IODINEO&M HALYARD, INC.141c3490-3f50-9246-e063-6394a90a553c2025-10-09WarningsExact identifier
rxcui: 312564
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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