Indications and uses
• aids in the prevention of dental cavities. • helps control bleeding gums. • helps interfere with harmful effects of plaque associated with gingivitis.
parodontax
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2025-12-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 12
- Source
- full-release
- Hydrated at
- 2026-06-01 01:27:39
Label at a glance#
Productparodontax
Active ingredientSTANNOUS FLUORIDE
Label structure12 sections
Dosage and administration
• adults and children 2 years of age and older: • brush teeth thoroughly, preferably after each meal at least twice a day, or as directed by a dentist or doctor. Minimize swallowing. • to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established. • children under 2 years of age: Consult a dentist or doctor.
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Stannous fluoride 0.454 % (0.15 % w/v fluoride ion)
Purposes
Anticavity
Antigingivitis
Uses
- aids in the prevention of dental cavities.
- helps control bleeding gums.
- helps interfere with harmful effects of plaque associated with gingivitis.
Warnings
Stop use and ask a dentist if
- 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 may be signs or symptoms of periodontitis, a serious form of gum disease.
Keep out of reach of children under 6 years of age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 years of age and older:
- brush teeth thoroughly, preferably after each meal at least twice a day, or as directed by a dentist or doctor. Minimize swallowing.
- to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
- children under 2 years of age: Consult a dentist or doctor.
Other information
- products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
- this product is specially formulated to help prevent staining.
- do not store above 25ºC (77ºF)
Inactive ingredients
glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin
Questions or comments?
Call toll-free 1-866-844-2797
Additional Information
ALWAYS FOLLOW THE LABEL
Healthy gums don’t bleed
If you spit blood when you brush or floss, it could be a sign of early gum disease. parodontax is clinically proven to help reduce bleeding gums* by removing the plaque buildup that can cause gums to swell and bleed.
parodontax is a daily fluoride toothpaste that also prevents cavities, provides fresh breath, and whitens – for healthy gums and strong teeth.
parodontax toothpaste offers a fresh, minty flavor.
*with twice daily brushing
Unhealthy gums
Healthy gums
ADA Accepted
American Dental Association ®
Principal Display Panel - Clean Mint
DENTIST RECOMMENDED
parodontax
TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION
CLEAN MINT
DAILY GUM CARE
HELPS CONTROL BLEEDING GUMS
NET WT 3.4 OZ (96.4 g)
Principal Display Panel – Extra Fresh
CLINICALLY PROVEN ∙ HEALTHY GUMS AND STRONG TEETH
NDC 0135-0599-02
parodontax
EXTRA FRESH
DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE
Helps prevent bleeding gums
NET WT
3.4 OZ (96.4 g)
PLAQUE BUILDS UP
GUMS SWELL AND BLEED
PARODONTAX HELPS REMOVE PLAQUE
Healthy gums don’t bleed
If you spit blood when you brush or floss it could be a sign of early gum disease. parodontax is clinically proven to help reduce bleeding gums by removing the plaque buildup that can cause gums to swell and bleed.
parodontax is a daily fluoride toothpaste that also prevents cavities, provides fresh breath and whitening- for healthy gums and strong teeth.
Principal Display Panel – Whitening
DENTIST RECOMMENDED
parodontax
TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION
WHITENING
DAILY GUM CARE
HELPS CONTROL BLEEDING GUMS
NET WT 3.4 OZ (96.4 g)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste | PSN | 12 |
| 416784 | stannous fluoride 0.00454 MG/MG Toothpaste | SCD | 12 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste | SY | 12 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste | SY | 12 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste | SY | 12 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0598-01 | parodontax | 96.4 g in 1 TUBE | PASTE | 96.4 | 12 | |
| 0135-0598-01 | parodontax | 1 in 1 CARTON | PASTE | 1 | 12 | |
| 0135-0598-02 | parodontax | 1 in 1 CARTON | PASTE | 1 | 12 | |
| 0135-0598-02 | parodontax | 23 g in 1 TUBE | PASTE | 23 | 12 | |
| 0135-0599-01 | parodontax | 23 g in 1 TUBE | PASTE | 23 | 12 | |
| 0135-0599-01 | parodontax | 1 in 1 CARTON | PASTE | 1 | 12 | |
| 0135-0599-02 | parodontax | 1 in 1 CARTON | PASTE | 1 | 12 | |
| 0135-0599-02 | parodontax | 96.4 g in 1 TUBE | PASTE | 96.4 | 12 | |
| 0135-0601-01 | parodontax | 96.4 g in 1 TUBE | PASTE | 96.4 | 12 | |
| 0135-0601-01 | parodontax | 1 in 1 CARTON | PASTE | 1 | 12 | |
| 0135-0601-02 | parodontax | 2 in 1 CARTON | PASTE | 2 | 12 | |
| 0135-0601-02 | parodontax | 96.4 g in 1 TUBE | PASTE | 96.4 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0598-01 | GM - Gram | 0135-0598 | c3e0bcda-0825-42d2-b06c-16ef4d35c439 | 1 | 2017-03-06 |
| 0135-0599-02 | GM - Gram | 0135-0599 | 64f30c3e-83fa-481b-b140-03bc80bb5cf7 | 1 | 2017-03-06 |
| 0135-0601-01 | GM - Gram | 0135-0601 | 5d289d50-b9f3-49b2-b927-2e1009c691c5 | 1 | 2017-03-06 |
Products#
Every source-derived product name is available through these pages.
- parodontax
- stannous fluoride
- FLUORIDE ION
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- HYDRATED SILICA
- SODIUM TRIPOLYPHOSPHATE ANHYDROUS
- SODIUM LAURYL SULFATE
- TITANIUM DIOXIDE
- CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
- COCAMIDOPROPYL BETAINE
- SACCHARIN SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0135-0598 | 0135-0598-01, 0135-0598-02 |
| 0135-0599 | 0135-0599-01, 0135-0599-02 |
| 0135-0601 | 0135-0601-01, 0135-0601-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| parodontax | STANNOUS FLUORIDE | Haleon US Holdings LLC | 0f07aa1a-97be-44af-92d8-a10777e24e0a | 2025-12-22 | Warnings | 0135-0599-01 0135-0601-02 0135-0599-02 0135-0601-01 0135-0598-02 0135-0598-01 0135-0598 0135-0599 0135-0601 00135059902 00135059802 00135059801 00135059901 00135060102 00135060101 c8ed1491-d424-49f6-b49e-56a938dc7328 0f07aa1a-97be-44af-92d8-a10777e24e0a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.