FDA.reportPublic FDA data

Kali Iodatum 1X

Manufacturer
OHM PHARMA INC.
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:15:22

Label at a glance#

ProductKali Iodatum 1X
Active ingredientPOTASSIUM IODIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT (HPUS*): Kali Iodatum 1X.

* ​The letters "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Pharmacopeia of the United States.

INDICATIONS & USAGE SECTION

USES: Temporarily relieves dysfunctional thyroid metabolism.**

**This statement has not been evaluated by the FDA. It is based on documented Homeopathic Materia Medica.

WARNINGS SECTION

WARNINGS: THIS PRODUCT CONTAINS IODIDE. DO NOT TAKE IF YOU ARE HIPERSENSITIVE OR ALLERGIC TO IODIDE. IF YOU ARE PREGNANT OR BREAST-FEEDING,ask a health care professional before use. If symptoms worsen or persist for more than a week, discontinue use and contact a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • ​Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Shake 10 times before use. Adults & children over 12 years of age: add 1 drop (3.83 mg iodide and 1.18 mg Potassium) to 1 oz of purified water. Take 1 times per day or as directed by a health care professional. Children under 12: contact a doctor.

OTHER SAFETY INFORMATION

Do not use if cap seal is broken.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ethanol Alcohol 5% (Non-GMO, Kosher Certified, Corn, Gluten Allergen Free), Glycerin, Purified Water.

OTC - QUESTIONS SECTION

Mfg. By: OHM Pharma, INC. Mineral Wells, TX 76067

www.ohmpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC MEDICINE

NDC: 66096-166-02

KALI IODATUM 1X

Natural - Safe - Effective

No Side Effects

1 fl oz (30mL) / 5% Alcohol

PRODUCT OF USA

1oz bottle label1oz bottle label

OTC - PURPOSE SECTION

Temporarily relieves dysfunctional thyroid metabolism.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-166-02Kali Iodatum 1X30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-166KALI IODATUM 1X (KALI IODATUM.) LIQUID [OHM PHARMA INC.]4Current NDC, Legacy NDC, 1 package rows20211230_682a651b-699d-45c6-8161-4b802cda1d7d.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66096-16666096-166-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
POTASSIUM IODIDE1C4QK22F9JACTIM

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
Kali Iodatum 1XKALI IODATUM.OHM PHARMA INC.682a651b-699d-45c6-8161-4b802cda1d7d2021-12-29WarningsExact identifier
ndc (package): 66096-166-02
ndc (product): 66096-166
ndc11 (package): 66096016602
spl id: d44b323b-080a-b3d4-e053-2995a90aafb7
spl set id: 682a651b-699d-45c6-8161-4b802cda1d7d

Reported adverse events (FAERS/openFDA)#

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