FDA.reportPublic FDA data

LEADER 2% Mild Iodine Tincture

Product NDC
70000-0401
11-digit product format
700000401
Labeler code
70000
Product ID
70000-0401_1855b847-f240-9f78-e063-6394a90a3df3
Type
HUMAN OTC DRUG
Nonproprietary name
Iodine and Sodium Iodide and Alcohol Liquid
Dosage form
LIQUID
Route
TOPICAL
Labeler
Cardinal Health, 110 dba Leader
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-15
Substance
SODIUM IODIDE; IODINE
Active strength
24; 20 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct70000-0401IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70000-040170000-0401-1IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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 2% Mild Iodine Tincture
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM IODIDE24 mg/mL
IODINE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5WR8N145CInternal UNII lookup
9679TC07X4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2284244Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7f810b92-60f6-2f72-e053-2991aa0ab973Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0401-12024-05-13C16284748780-11030e365-2ef8-111a-e063-dadaa90a10e2LEADER 2% Mild Iodine Tincture
70000-0401-12024-01-30C16284748780-11030e365-2ef8-111a-e063-dadaa90a10e2LEADER 2% Mild Iodine Tincture

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0401-1LEADER 2% Mild Iodine Tincture30 mL in 1 BOTTLE, PLASTICLIQUID305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0401-1ML - Milliliter70000-0401991c2419-4dc6-480a-89f9-187c53ec5be112019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0401LEADER 2% MILD IODINE TINCTURE (IODINE AND SODIUM IODIDE AND ALCOHOL LIQUID) LIQUID [CARDINAL HEALTH, 110 DBA LEADER]5Current NDC, Legacy NDC, 1 package rows20240514_7f810b92-60f6-2f72-e053-2991aa0ab973.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 93 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5ee961-1d64-0d9d-e053-2a95a90a60102024-12-18WarningsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLSZY Holdings, LLC dba EverReady First Aid1e39b0f4-66d1-47ac-aed6-d6ac019888ce2024-12-18WarningsExact identifier
application number: M003
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5eb0df-cd2d-691c-e053-2995a90a25112024-12-18WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLFirst Aid Research Corp.7d1c0382-31b3-48d0-a514-c5cc45a2299e2024-12-18WarningsExact identifier
application number: M003
First Aid Only First Aid-BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEAcme United Corporationf31a44ff-e4ac-de1e-e053-2a95a90ab0362024-12-18WarningsExact identifier
application number: M003
Hand Sanitizer (Lavender Rosemary)HAND SANITIZER SPRAYTubby Todd2992a52a-21a9-18be-e063-6294a90a834d2024-12-18WarningsExact identifier
application number: M003
CVS Decolorized IodineALCOHOLCVS Pharmacyd9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd2024-12-18WarningsExact identifier
application number: M003
De La Cruz Decolorized IodineETHYL ALCOHOLDLC Laboratories, Inc.5d8f6aaa-0b87-1166-e053-2991aa0a297f2024-12-18WarningsExact identifier
application number: M003
Humco Povidone IodinePOVIDONE IODINE 10%Humco Holding Group, Inc.1e078022-f32c-48bd-8add-f83aebcc58122024-12-18WarningsExact identifier
application number: M003
Univ of Vermont Medical Center AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7841cfa9-e94e-4c3d-b5fb-6769240178452024-12-17WarningsExact identifier
application number: M003
Northside Hospital Mothers VaginalALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7f1a85fd-086b-4fc7-abac-863dd3ea505a2024-12-17WarningsExact identifier
application number: M003
Mary Kay Satin Hands Shea Hand SanitizerALCOHOLMary Kay Inc.b6c2b979-2940-1569-e053-2995a90a532c2024-12-17WarningsExact identifier
application number: M003
Foster and Thrive Decolorized IodineALCOHOL LIQUIDStrategic Sourcing Services, LLC2981529a-2bd0-3e9e-e063-6294a90a72362024-12-17WarningsExact identifier
application number: M003
Foster and Thrive 2% Mild Iodine TinctureIODINE AND SODIUM IODIDE AND ALCOHOL LIQUIDStrategic Sourcing Services, LLC2981cb97-17de-ebda-e063-6394a90ad2812024-12-17WarningsExact identifier
application number: M003
Northside Hospital H.E.A.R.T. Strings ToteALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLcf8369a27-1995-4fdd-a282-35c344c11d832024-12-17WarningsExact identifier
application number: M003
Northside Hospital Amenity KitALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLc877ce875-c5b0-4d9b-8f00-682914e3bc0e2024-12-17WarningsExact identifier
application number: M003
Wellstar AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcced9dd96-7922-43d7-906f-32afaad733ec2024-12-17WarningsExact identifier
application number: M003
Northside Hospital C-Section MothersALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc9df6d0e9-631c-4619-9d96-d2c5a32a590e2024-12-17WarningsExact identifier
application number: M003
Memorial Sloan Kettering Cancer Center Amenity KitSODIUM MONOFLUOROPHOSPHATEASP Global, LLccab0bef1-f486-4eac-a61b-6030467d86502024-12-17WarningsExact identifier
application number: M003
Sarasota Memorial AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcf5dda019-fcfd-4e99-89cc-e79e76b402e72024-12-17WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2284244iodine 2 % / sodium iodide 2.4 % Topical SolutionPSN7f810b92-60f6-2f72-e053-2991aa0ab9735
2284244iodine 20 MG/ML / sodium iodide 24 MG/ML Topical SolutionSCD7f810b92-60f6-2f72-e053-2991aa0ab9735
2284244iodine 2 % / sodium iodide 2.4 % Topical SolutionSY7f810b92-60f6-2f72-e053-2991aa0ab9735

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0401-17000004010130 mL in 1 BOTTLE, PLASTIC (70000-0401-1) 30 ml2019-01-150000-00-00NoNoCurrent