Betadine Gargle

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: Betadine Gargle
Generic name: POVIDONE-IODINE
Manufacturer: Atlantis Consumer Healthcare, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 5f0a3377-1398-2603-c632-f0d214bb88ec
SPL ID: 803ae961-c01c-4910-91f7-4f668956d3ad
Version: 10
Effective date: 2026-01-21
Source export date: 2026-10-12
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:13:09

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M022	openfda.application_number
brand name		Betadine Gargle	openfda.brand_name
generic name		POVIDONE-IODINE	openfda.generic_name
manufacturer name		Atlantis Consumer Healthcare, Inc.	openfda.manufacturer_name
ndc	package	67618-181-08	openfda.package_ndc
ndc	package	67618-181-16	openfda.package_ndc
ndc	product	67618-181	openfda.product_ndc
ndc11	package	67618018116	derived:openfda.package_ndc
ndc11	package	67618018108	derived:openfda.package_ndc
rxcui		2374363	openfda.rxcui
rxcui		314935	openfda.rxcui
spl id		803ae961-c01c-4910-91f7-4f668956d3ad	id
spl set id		5f0a3377-1398-2603-c632-f0d214bb88ec	set_id
unii		85H0HZU99M	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

Warnings SoreThroat Warning: Severe or persistent sore throat or sore throataccompanied by high fever, headache, nausea, and vomiting may be serious.Consult doctor promptly. Do not use more than 2 days or administerto children under 3 years of age unless directed by a doctor. Do not use this product for more than 7 days unless directed by a dentist or doctor if you are allergic to povidone-iodine or any other ingredientsin this product if you have any thyroid conditions When using this product do not get into eyes. If contact occurs, rinse eyes thoroughlywith water. If irritation persists, consult a doctor do not swallow do not use with hydrogen peroxide Stop use and ask a doctor if symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops

Reported adverse events (FAERS/openFDA)#

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