FDA.reportPublic FDA data

NDC 0116-0160 - Betadine

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
0116-0160
Package NDCs from labels
0116-0160-03
Manufacturer
Xttrium Laboratories, Inc.
Effective date
2025-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
5% Betadine Spray 3ozXttrium Laboratories, Inc.2025-05-15HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0160BETADINE (POVIDONE-IODINE) LIQUID [XTTRIUM LABORATORIES, INC.]2Unmatched20250519_265add32-3227-e05a-e063-6394a90a7371.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 8 of 21 · 402 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dukal Povidone-Iodine Scrub Winged SpongesPOVIDONE-IODINE SCRUB WINGED SPONGESDukal LLCe8bce905-929e-30e4-e053-2a95a90a909f2025-11-19WarningsExact identifier
unii: 85H0HZU99M
Dukal Povidone-Iodine Paint Sponge StickPOVIDONE-IODINE PAINT SPONGE STICKDukal LLCf1dc2bc6-f459-af82-e053-2995a90afbd72025-11-19WarningsExact identifier
unii: 85H0HZU99M
PVP-I Prep Pads paper-foilPOVIDONE-IODINEDukal LLCf4596b0c-0e04-d71a-e053-2995a90a3b202025-11-19WarningsExact identifier
unii: 85H0HZU99M
Dukal Povidone-Iodine Scrub Sponge SticksPOVIDONE-IODINE SCRUB SPONGE STICKSDukal LLCf6f5dc9a-b578-70c1-e053-6394a90acdb02025-11-19WarningsExact identifier
unii: 85H0HZU99M
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
Betadine Solution SwabsticksPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.0707b259-52a4-4ae6-b176-d093865906e72025-11-11WarningsExact identifier
unii: 85H0HZU99M
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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
unii: 85H0HZU99M

Reported adverse events (FAERS/openFDA)#

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