warnings
Warning Keep Out of Reach of Children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
SENSODYNE PRONAMEL Intensive Enamel Repair Clean 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
- Brand name
- SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint
- Generic name
- SODIUM FLUORIDE
- Manufacturer
- Haleon US Holdings LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 817c0dad-d109-428e-adb5-3354604acc94
- SPL ID
- 0a03a9b2-cbbd-4b73-91db-aea9d3a32264
- Version
- 3
- Effective date
- 2024-10-28
- Source export date
- 2026-11-06
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/b00a73f24c6ff050408c570063640e3d80d1f71dfc9a165d1cf072a25659445a/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 07:02:47
| 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.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application number | M022 | openfda.application_number | |
| brand name | SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint | openfda.brand_name | |
| brand name | SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh | openfda.brand_name | |
| generic name | SODIUM FLUORIDE | openfda.generic_name | |
| manufacturer name | Haleon US Holdings LLC | openfda.manufacturer_name | |
| ndc | package | 0135-0451-01 | openfda.package_ndc |
| ndc | package | 0135-0449-01 | openfda.package_ndc |
| ndc | product | 0135-0451 | openfda.product_ndc |
| ndc | product | 0135-0449 | openfda.product_ndc |
| ndc11 | package | 00135044901 | derived:openfda.package_ndc |
| ndc11 | package | 00135045101 | derived:openfda.package_ndc |
| rxcui | 240698 | openfda.rxcui | |
| spl id | 0a03a9b2-cbbd-4b73-91db-aea9d3a32264 | id | |
| spl set id | 817c0dad-d109-428e-adb5-3354604acc94 | set_id | |
| unii | 8ZYQ1474W7 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.