TheraBreath

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: TheraBreath
Generic name: SODIUM FLUORIDE
Manufacturer: Church & Dwight Co., Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 53c1086d-264b-9d00-e063-6394a90ad19d
SPL ID: 5b11930d-111a-400e-e063-6294a90a9e6b
Version: 2
Effective date: 2026-09-09
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:07:53

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M021	openfda.application_number
brand name		TheraBreath	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Church & Dwight Co., Inc.	openfda.manufacturer_name
ndc	package	10237-260-16	openfda.package_ndc
ndc	package	10237-274-01	openfda.package_ndc
ndc	product	10237-274	openfda.product_ndc
ndc11	package	10237027401	derived:openfda.package_ndc
ndc11	package	10237026016	derived:openfda.package_ndc
spl id		5b11930d-111a-400e-e063-6294a90a9e6b	id
spl set id		53c1086d-264b-9d00-e063-6394a90ad19d	set_id

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 Whitening Oral Rinse Keep out of reach of children under 12 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If spilled on fabrics, wash out immediately. This product was sealed with protective packaging. If seal is broken or missing, do not use. Anticavity Oral Rinse Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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