Thyrosafe

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Thyrosafe
Generic name: POTASSIUM IODIDE
Manufacturer: BTG International Inc
Product type: HUMAN OTC DRUG
SPL set ID: 30387dc3-da14-1964-e063-6394a90afa4e
SPL ID: 596697f9-8674-0e84-e063-6294a90a5efe
Version: 2
Effective date: 2026-08-19
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:48:40

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	076350	derived:openfda.application_number
application number		ANDA076350	openfda.application_number
brand name		Thyrosafe	openfda.brand_name
generic name		POTASSIUM IODIDE	openfda.generic_name
manufacturer name		BTG International Inc	openfda.manufacturer_name
ndc	package	50633-920-20	openfda.package_ndc
ndc	product	50633-920	openfda.product_ndc
ndc11	package	50633092020	derived:openfda.package_ndc
rxcui		312539	openfda.rxcui
rxcui		2735395	openfda.rxcui
spl id		596697f9-8674-0e84-e063-6294a90a5efe	id
spl set id		30387dc3-da14-1964-e063-6394a90afa4e	set_id
unii		1C4QK22F9J	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNING People who are allergic to iodine, have dermatitis herpetiformis or hypocomplementemic vasculitis, or have nodular thyroid disease with heart disease should not take KI. Keep out of the reach of children. In case of an allergic reaction (difficulty breathing, speaking or swallowing; wheezing; shortness of breath or swelling of the mouth or throat), call 911 or get medical care right away. In case of overdose, get medical help or call a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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