FDA.reportPublic FDA data

Lugols Strong Iodine

Product NDC
59365-6064
Requested package NDC
59365-6064-1
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59365-606459365-6064-1IInactivated by FDA2026-10-05

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
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