FDA.reportPublic FDA data

Henry Schein Povidone-Iodine Prep Pad

Product NDC
0404-0121
11-digit product format
004040121
Labeler code
0404
Product ID
0404-0121_5cc6fdcd-7aa1-b26c-e063-6394a90a01be
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SWAB
Route
TOPICAL
Labeler
Henry Schein, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-22
Substance
POVIDONE-IODINE
Active strength
1 g/100mL
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
Henry Schein Povidone-Iodine Prep Pad
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE1 g/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0121-01Henry Schein Povidone-Iodine Prep Pad0.5 mL in 1 POUCHSWAB0.53
0404-0121-01Henry Schein Povidone-Iodine Prep Pad8000 in 1 CASESWAB80003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0121HENRY SCHEIN POVIDONE-IODINE PREP PAD (POVIDONE-IODINE) SWAB [HENRY SCHEIN, INC.]3Current NDC, Legacy NDC, 2 package rows20231014_313416b8-60b2-4a77-9b56-5c507aae9072.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 107 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Burn with LidocaineBENZALKONIUM CHLORIDE, LIDOCAINEUnifirst First Aid Corporationbd46efc8-0b36-0931-e053-2a95a90adb6f2024-01-17WarningsExact identifier
application number: M003
Green Guard AntisepticBENZALKONIUM CHLORIDEUnifirst First Aid Corporationbc914c36-e0f0-18c5-e053-2a95a90a894e2024-01-17WarningsExact identifier
application number: M003
Medi-First Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationbca2b641-7fbc-5462-e053-2995a90ae2b42024-01-17WarningsExact identifier
application number: M003
Medi-First Isopropyl Alcohol 70%ISOPROPYL ALCOHOLUnifirst First Aid Corporationdbeac2f5-b897-5e71-e053-2995a90a75492024-01-17WarningsExact identifier
application number: M003
Green Guard Hydrogen PeroxideHYDROGEN PEROXIDEUnifirst First Aid Corporationbca4545e-d477-270a-e053-2995a90a0ed62024-01-17WarningsExact identifier
application number: M003
MyMedic Calendula GelCALENDULA OFFICINALIS FLOWERNantong Health & Beyond Hygienic Products Inc.0f0aa235-ac35-ac91-e063-6394a90a73fc2024-01-16WarningsExact identifier
application number: M003
MyMedic Oral Pain Relief GelBENZOCAINENantong Health & Beyond Hygienic Products Inc.0f0b6157-ec18-13ef-e063-6294a90a2e0c2024-01-16WarningsExact identifier
application number: M003
MyMedic Super SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.0f0c535d-8ff3-4799-e063-6394a90a70632024-01-16WarningsExact identifier
application number: M003
MyMedic Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0f0d1ba7-fe9c-8e0b-e063-6394a90a30812024-01-16WarningsExact identifier
application number: M003
White PetrolatumWHITE PETROLATUMNantong Health & Beyond Hygienic Products Inc.0f0d6ff0-ff30-aaf8-e063-6394a90a27162024-01-16WarningsExact identifier
application number: M003
Thompson Hand SanitizerETHYL ALCOHOLThompsondeada606-8a82-9eeb-e053-2a95a90a9e6d2024-01-16WarningsExact identifier
application number: M003
MyMedic Arnica GelARNICA MONTANANantong Health & Beyond Hygienic Products Inc.0ef8760d-27c0-7ece-e063-6294a90a68732024-01-15WarningsExact identifier
application number: M003
American Safety First Aid AntispeticHYDROGEN PEROXIDEOrazen Incea2fbdfe-1932-9fb4-e053-2a95a90a35632024-01-15WarningsExact identifier
application number: M003
First Aid AntispeticBENZALKONIUM CHLORIDEOrazen Incea2debcb-892c-339f-e053-2a95a90a4b182024-01-15WarningsExact identifier
application number: M003
Ever Ready First AidBENZALKONIUM CHLORIDE, LIDOCAINE HCIEver Ready First Aide53f3bf5-25c0-2b86-e053-2a95a90a010f2024-01-15WarningsExact identifier
application number: M003
FIRST SHIELD First Aid AntisepticBENZALKONIUM CHLORIDEEver Ready First Aide013ef0a-ef3d-7af5-e053-2a95a90a54d32024-01-15WarningsExact identifier
application number: M003
Latalia Hand Sanitizer 80 Alcohol AntisepticALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTDae55fab3-3177-383e-e053-2995a90a17a02024-01-10WarningsExact identifier
application number: M003
Latalia Sanitizing WipeALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTDae564635-898e-fbf6-e053-2995a90a81192024-01-10WarningsExact identifier
application number: M003
Latalia Sanitizing WipesALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTDaf850b5e-c99f-3d4e-e053-2995a90a79482024-01-10WarningsExact identifier
application number: M003
Latalia Alcohol Antiseptic 80 SanitizingALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTDba4b8fb3-09db-fa29-e053-2995a90a86172024-01-10WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797730povidone-iodine 10 % Medicated PadPSN313416b8-60b2-4a77-9b56-5c507aae90723
797730povidone-iodine 100 MG/ML Medicated PadSCD313416b8-60b2-4a77-9b56-5c507aae90723
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY313416b8-60b2-4a77-9b56-5c507aae90723
797730povidone-iodine 10 % Medicated PadSY313416b8-60b2-4a77-9b56-5c507aae90723
797730povidone-iodine 10 % Medicated SwabstickSY313416b8-60b2-4a77-9b56-5c507aae90723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-0121-01004040121018000 POUCH in 1 CASE (0404-0121-01) / .5 mL in 1 POUCH8000 pouch2019-10-220000-00-00NoNoCurrent