{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "parodontax stannous fluoride 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 parodontax stannous fluoride 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 parodontax stannous fluoride 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" ], "active_ingredient": [ "Active ingredient Stannous fluoride 0.454 % (0.15 % w/v fluoride ion)" ], "purpose": [ "Purposes Anticavity Antigingivitis" ], "indications_and_usage": [ "Uses • aids in the prevention of dental cavities. • helps control bleeding gums. • helps interfere with harmful effects of plaque associated with gingivitis." ], "warnings": [ "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." ], "stop_use": [ "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": [ "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." ], "dosage_and_administration": [ "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_safety_information": [ "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_ingredient": [ "Inactive ingredients glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin" ], "questions": [ "Questions or comments? Call toll-free 1-866-844-2797" ], "spl_unclassified_section": [ "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 ®" ], "package_label_principal_display_panel": [ "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) Parodontax Clean Mint 3.4 oz", "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. Parodontax Extra Fresh 3.4 oz", "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) Parodontax Whitening 3.4 oz" ], "set_id": "0f07aa1a-97be-44af-92d8-a10777e24e0a", "id": "c8ed1491-d424-49f6-b49e-56a938dc7328", "effective_time": "20251222", "version": "12", "openfda": { "application_number": [ "M022" ], "brand_name": [ "parodontax" ], "generic_name": [ "STANNOUS FLUORIDE" ], "manufacturer_name": [ "Haleon US Holdings LLC" ], "product_ndc": [ "0135-0598", "0135-0599", "0135-0601" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "DENTAL" ], "substance_name": [ "STANNOUS FLUORIDE" ], "rxcui": [ "416784" ], "spl_id": [ "c8ed1491-d424-49f6-b49e-56a938dc7328" ], "spl_set_id": [ "0f07aa1a-97be-44af-92d8-a10777e24e0a" ], "package_ndc": [ "0135-0598-01", "0135-0598-02", "0135-0599-01", "0135-0599-02", "0135-0601-01", "0135-0601-02" ], "is_original_packager": [ true ], "unii": [ "3FTR44B32Q" ] } } ] }