FDA.reportPublic FDA data

Lugols Strong Iodine

Product NDC
59365-6064
11-digit product format
593656064
Labeler code
59365
Product ID
59365-6064_0345da45-be35-402b-a37d-c7f1ec510a50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Iodine and Potassium Iodide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
CooperSurgical, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1992-10-01
Marketing end
0000-00-00
Substance
IODINE; POTASSIUM IODIDE
Active strength
0 g/mL; g/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
59365-6064-12021-01-29C16284748780-1ba0f9c33-1788-a910-e053-dadaa90a0b85Lugols Strong Iodine Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59365-6064-0Lugols Strong Iodine8 mL in 1 VIAL, SINGLE-USESOLUTION810
59365-6064-1Lugols Strong Iodine12 in 1 CARTONSOLUTION1210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59365-6064-0ML - Milliliter59365-60647dbe9896-21f0-4afc-8ee6-a102250d829b12013-10-17
59365-6064-1ML - Milliliter59365-6064ab8e656b-296e-4c35-8f6c-4b2af90e5c5212015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IODINEACTIVE INGREDIENT9679TC07X4LUGOLS STRONG IODINE (IODINE AND POTASSIUM IODIDE) SOLUTION [COOPERSURGICAL, INC.]8
POTASSIUM IODIDEACTIVE INGREDIENT1C4QK22F9JLUGOLS STRONG IODINE (IODINE AND POTASSIUM IODIDE) SOLUTION [COOPERSURGICAL, INC.]8
IODIDE IONACTIVE MOIETY09G4I6V86QLUGOLS STRONG IODINE (IODINE AND POTASSIUM IODIDE) SOLUTION [COOPERSURGICAL, INC.]8
IODINEACTIVE MOIETY9679TC07X4LUGOLS STRONG IODINE (IODINE AND POTASSIUM IODIDE) SOLUTION [COOPERSURGICAL, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59365-6064LUGOLS STRONG IODINE (IODINE AND POTASSIUM IODIDE) SOLUTION [COOPERSURGICAL, INC.]10Legacy NDC, 2 package rows20210318_7d8f4f37-948c-4740-8e23-2f23e47ebd5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205228iodine 5 % / potassium iodide 10 % Topical SolutionPSN7d8f4f37-948c-4740-8e23-2f23e47ebd5b10
205228iodine 50 MG/ML / potassium iodide 100 MG/ML Topical SolutionSCD7d8f4f37-948c-4740-8e23-2f23e47ebd5b10
205228iodine 5 % / potassium iodide 10 % Topical SolutionSY7d8f4f37-948c-4740-8e23-2f23e47ebd5b10
205228Iodine 50 MG/ML / K+ Iodide 100 MG/ML Topical SolutionSY7d8f4f37-948c-4740-8e23-2f23e47ebd5b10
205228Iodine 50 MG/ML / Pot Iodide 100 MG/ML Topical SolutionSY7d8f4f37-948c-4740-8e23-2f23e47ebd5b10
205228Lugol's strong iodine 5 % / 10 % Topical SolutionSY7d8f4f37-948c-4740-8e23-2f23e47ebd5b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59365-6064-0593656064008 mL in 1 VIAL, SINGLE-USE8 mlHistorical
59365-6064-15936560640112 VIAL, SINGLE-USE in 1 CARTON (59365-6064-1) > 8 mL in 1 VIAL, SINGLE-USE (59365-6064-0) 1992-10-010000-00-00NoNoCurrent