SENSODYNE Sensitivity Gum and Enamel Mint

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: SENSODYNE Sensitivity Gum and Enamel Mint
Generic name: STANNOUS FLUORIDE
Manufacturer: Haleon US Holdings LLC
Product type: HUMAN OTC DRUG
SPL set ID: d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2
SPL ID: 13128d65-3388-ef9b-e063-6394a90af6ff
Version: 4
Effective date: 2024-03-07
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:15:06

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M022	openfda.application_number
brand name		SENSODYNE Sensitivity Gum and Enamel Mint	openfda.brand_name
generic name		STANNOUS FLUORIDE	openfda.generic_name
manufacturer name		Haleon US Holdings LLC	openfda.manufacturer_name
ndc	package	0135-5022-01	openfda.package_ndc
ndc	package	0135-5022-03	openfda.package_ndc
ndc	package	0135-5022-02	openfda.package_ndc
ndc	product	0135-5022	openfda.product_ndc
ndc11	package	00135502203	derived:openfda.package_ndc
ndc11	package	00135502202	derived:openfda.package_ndc
ndc11	package	00135502201	derived:openfda.package_ndc
rxcui		416784	openfda.rxcui
spl id		13128d65-3388-ef9b-e063-6394a90af6ff	id
spl set id		d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2	set_id
unii		3FTR44B32Q	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 Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use. gingivitis, bleeding, or redness persists for more than 2 weeks. you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These maybe signs or symptoms of periodontitis, a serious form of gum disease. 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.