FDA.reportPublic FDA data

Leader Povidone-Iodine 10% Topical Solution

Product NDC
70000-0060
11-digit product format
700000060
Labeler code
70000
Product ID
70000-0060_5d2e72eb-db0a-3a54-e063-6394a90a1cfa
Type
HUMAN OTC DRUG
Nonproprietary name
Povidone Iodine Prep Solution 10%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Cardinal Health
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-25
Substance
POVIDONE-IODINE
Active strength
10 mg/mL
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
Leader Povidone-Iodine 10% Topical Solution
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0060-1Leader Povidone-Iodine 10% Topical Solution237 mL in 1 BOTTLELIQUID2376

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0060-1ML - Milliliter70000-0060fda308d7-4327-4c14-99b2-89e915757dc512022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0060LEADER POVIDONE-IODINE 10% TOPICAL SOLUTION (POVIDONE IODINE PREP SOLUTION 10%) LIQUID [CARDINAL HEALTH]5Current NDC, Legacy NDC, 1 package rows20241127_b023e2e3-a4af-eb19-e053-2995a90a7c6e.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 45 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone-lodine prep padPOVIDONE-LODINE PREP PADSHENZHEN BENLIJU BIO-TECH CO.,LTD201545b8-0697-5601-e063-6394a90a12f42026-01-05WarningsExact identifier
application number: M003
Sting Relief prep PadSTING RELIEF PREP PADSHENZHEN BENLIJU BIO-TECH CO.,LTD202c7b77-1a48-52a5-e063-6394a90a2eb22026-01-05WarningsExact identifier
application number: M003
Skin Cleaning Care WipesSKIN CLEANING CARE WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD203d7a95-65fe-ca65-e063-6294a90acc6e2026-01-05WarningsExact identifier
application number: M003
ANTISEPTIC CLEANSING WIPE(0.9% NACL)ANTISEPTIC CLEANSING WIPE(0.9% NACL)SHENZHEN BENLIJU BIO-TECH CO.,LTD33e1c026-8a35-a47a-e063-6294a90a24062026-01-05WarningsExact identifier
application number: M003
Hand Sanitizing WipesHAND SANITIZING WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD37487da6-4e0e-6625-e063-6394a90a0af12026-01-05WarningsExact identifier
application number: M003
Hand wipesHAND WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD39f3acca-7275-88ca-e063-6394a90ad1a22026-01-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Vanilla HeavenALCOHOLShenzhen Lantern Scicence Co.,Ltd.47a0781b-9b25-f04b-e063-6294a90ae7e52026-01-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.47a16397-dff3-7d79-e063-6394a90a040f2026-01-05WarningsExact identifier
application number: M003
IDOSWAB BISOPROPYL ALCOHOLIDO PHARM16d19630-b67a-f3e1-e063-6394a90a74292026-01-05WarningsExact identifier
application number: M003
Sure Comfort Alcohol Prep PadsISOPROPYL ALCOHOLIDO PHARM27def94b-d3a6-18b7-e063-6394a90a22a62026-01-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Lemon LimeALCOHOLShenzhen Lantern Scicence Co.,Ltd.47aeaae9-740d-a28a-e063-6294a90a64602026-01-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Calming LavenderALCOHOLShenzhen Lantern Scicence Co.,Ltd.47aeeef9-0eed-e7d0-e063-6394a90a6d312026-01-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Coconut BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.47af27a7-3df9-270a-e063-6394a90abc7d2026-01-05WarningsExact identifier
application number: M003
Hand SanitiserALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a44d82bf-68a3-56bc-e053-2995a90ae5262026-01-05WarningsExact identifier
application number: M003
Green Island SanitiserALCOHOLZhejiang Guoyao Aerosol Co., Ltda7d1df16-3566-badf-e053-2a95a90aa61a2026-01-05WarningsExact identifier
application number: M003
Green IslandETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a7443a72-6ee5-07f7-e053-2995a90a33412026-01-05WarningsExact identifier
application number: M003
SHABOINKETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a8bc5da3-8660-6343-e053-2995a90ac9052026-01-05WarningsExact identifier
application number: M003
SHABOINKETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a8c0c9ce-05ac-0f33-e053-2a95a90ab8ed2026-01-05WarningsExact identifier
application number: M003
H2OneETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.a9bcecf7-7767-69b4-e053-2995a90a92472026-01-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer MermicornoALCOHOLShenzhen Lantern Scicence Co.,Ltd.47af97d6-ae84-adfe-e063-6394a90aa7772026-01-05WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSNb023e2e3-a4af-eb19-e053-2995a90a7c6e6
312564povidone-iodine 100 MG/ML Topical SolutionSCDb023e2e3-a4af-eb19-e053-2995a90a7c6e6
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSYb023e2e3-a4af-eb19-e053-2995a90a7c6e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0060-170000006001237 mL in 1 BOTTLE (70000-0060-1) 237 ml2020-09-250000-00-00NoNoCurrent