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: POTASSIUM NITRATE, SODIUM FLUORIDE
Manufacturer: Church & Dwight Co., Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 4b812a38-f7cb-51c8-e063-6394a90ab82c
SPL ID: 59906b37-9bbf-710d-e063-6294a90abee4
Version: 2
Effective date: 2026-08-21
Source export date: 2026-10-27
Source partition: 14
Source file: https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/9122bd1bdced046e8f62ea012d80757473b7d83ea1faeea61faef490e06fd630/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 21:10:23

Harmonized routes table
Harmonized routes
DENTAL

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 · 16 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		POTASSIUM NITRATE, SODIUM FLUORIDE	openfda.generic_name
manufacturer name		Church & Dwight Co., Inc.	openfda.manufacturer_name
ndc	package	10237-273-07	openfda.package_ndc
ndc	package	10237-273-04	openfda.package_ndc
ndc	package	10237-273-24	openfda.package_ndc
ndc	product	10237-273	openfda.product_ndc
ndc11	package	10237027304	derived:openfda.package_ndc
ndc11	package	10237027307	derived:openfda.package_ndc
ndc11	package	10237027324	derived:openfda.package_ndc
rxcui		1038929	openfda.rxcui
spl id		59906b37-9bbf-710d-e063-6294a90abee4	id
spl set id		4b812a38-f7cb-51c8-e063-6394a90ab82c	set_id
unii		8ZYQ1474W7	openfda.unii
unii		RU45X2JN0Z	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 Do not use longer than 4 weeks unless recommended by a dentist or doctor Stop use and ask a dentist or doctor if sensitivity persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Keep out of reach of children. If more than used for brushing 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.