FDA.reportPublic FDA data

Lugols Solution

Manufacturer
PURTEX INC
Effective date
2019-11-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:30:18

Label at a glance#

ProductLugols Solution
Active ingredientIODINE
Label structure2 sections

Label contents#

Full prescribing information#

Single Use Only. CAUTION: Restricted to use by or on the order of a physcian. Do not use if seal has been broken.

BOXED WARNING SECTION

LugolLugol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LugolsLugols

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
70804-005-082021-01-29C16284748780-1ba0f9c33-29ec-a910-e053-dadaa90a0b85Restricted to use by or on the order of a licensed Physician. Keep cap tightly sealed and protect from light

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70804-005-08Lugols Solution1 g in 1 VIALSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70804-005LUGOLS SOLUTION (IODINE) SOLUTION [PURTEX INC]2Legacy NDC, 1 package rows20191110_406b1c3c-c4a2-5eb3-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70804-00570804-005-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
IODINE9679TC07X4ACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
96b0cfea-8787-2ec0-e053-2a95a90ad322406b1c3c-c4a2-5eb3-e054-00144ff88e882019-11-06Boxed warningExact identifier
spl id: 96b0cfea-8787-2ec0-e053-2a95a90ad322
spl set id: 406b1c3c-c4a2-5eb3-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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