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
IODINE; SODIUM IODIDE
Active strength
20; 24 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LEADER 2% Mild Iodine Tincture
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9679TC07X4, F5WR8N145C
Rxcui2284244

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

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