FDA.reportPublic FDA data

KALI IODATUM 1X

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:35:57

Label at a glance#

ProductKALI IODATUM 1X
Active ingredientPOTASSIUM IODIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (HPUS*): Kali Iodatum 1X

OTC - PURPOSE SECTION

Uses:  Temporarily relieves swelling with pain.**

INDICATIONS & USAGE SECTION

Uses:  Temporarily relieves swelling with pain.**

DOSAGE & ADMINISTRATION SECTION

Directions:  Adults & children above 12 years:  1 drop orally once daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN.  In case of overdose (or accidental ingestion)   get    medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

WARNINGS SECTION

WARNINGS:

  *Consult a physician for use in children under 12 years of age.

  * IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.

  * KEEP OUT OF THE REACH OF CHILDREN.  In case of overdose (or accidental ingestion)   get    medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Ethyl Alcohol USP, Glycerin USP, Purified Water.

OTC - QUESTIONS SECTION

Questions & Comments?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

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

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0094-1

KALI IODATUM 1X

HOMEOPATHIC

1 fl oz (30 mL) 5% Alcohol

UPC: 877730003881

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130877730003881GTIN-13: 0877730003881
EAN-13: 0877730003881
GTIN-12: 877730003881
UPC-A: 877730003881
GTIN storage (14 digits): 00877730003881		KALI IODATUM 1X.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0094-12023-01-10C16284748780-1d6a99b39-d370-a426-e053-dadaa90af4c2KALI IODATUM 1X
43406-0094-12022-01-28C16284748780-1d6a99b39-d370-a426-e053-dadaa90af4c2KALI IODATUM 1X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0094-1KALI IODATUM 1X30 mL in 1 BOTTLE, DROPPERLIQUID304

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-009443406-0094-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM IODIDE1C4QK22F9JACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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 1XPOTASSIUM IODIDENatural Creations, Inc.15eb7796-9787-454d-91a9-066b1dec9fd02025-12-16WarningsExact identifier
ndc (package): 43406-0094-1
ndc (product): 43406-0094
ndc11 (package): 43406009401
spl id: 942de3fe-3159-4e71-a64a-8704b291732a
spl set id: 15eb7796-9787-454d-91a9-066b1dec9fd0

Reported adverse events (FAERS/openFDA)#

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