FDA.reportPublic FDA data

parodontax

Manufacturer
Haleon US Holdings LLC
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:27:58

Label at a glance#

Productparodontax Active Gum Repair Breath Freshener
Active ingredientSTANNOUS FLUORIDE
Label structure10 sections

Indications and uses

• aids in the prevention of dental cavities. • helps control bleeding gums. • helps interfere with harmful effects of plaque associated with gingivitis.

Dosage and administration

• adults and children 2 years of age and older: • brush teeth thoroughly, preferably after each meal or 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

OTC - PURPOSE SECTION

Anticavity

Antigingivitis

Uses

INDICATIONS & USAGE SECTION

  • aids in the prevention of dental cavities.
  • helps control bleeding gums.
  • helps interfere with harmful effects of plaque associated with gingivitis.

Warnings

WARNINGS SECTION

Stop use and ask a dentist if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older:
    • brush teeth thoroughly, preferably after each meal or 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin, zinc chloride, carrageenan

Questions or comments?

OTC - QUESTIONS SECTION

1-855-328-5202

Additional information

SPL UNCLASSIFIED SECTION

ALWAYS FOLLOW THE LABEL

parodontax ACTIVE GUM REPAIR
Bleeding, redness, swelling, and bad breath can be signs of gum disease.

parodontax Active Gum RepairBreath Freshener is a daily fluoride toothpaste that reduces signs of early gum disease and uses Breath Cleanse Technology to purify bad breath instead of just masking it. Specially formulated to kill plaque bacteria at the gumline to help keep the gum seal tight.

Its Breath Cleanse Technology utilizes zinc, an ingredient clinically proven to purify the gases that cause bad breath.

*vs. a regular toothpaste used by people who have gingivitis

Targets plaque bacteria

Fights early gum problems

Reduces bad breath

breathcleanse TECHNOLOGY

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DENTIST RECOMMENDED

parodontax

TOOTHPASTE FOR ANTIGINGIVITIS AND CAVITY PREVENTION

ACTIVE GUM REPAIR

BREATH FRESHENER

CLINICALLY PROVEN TO REDUCE SIGNS OF EARLY GUM DISEASE*:

✓ BLEEDING ✓ REDNESS ✓ SWELLING ✓BAD BREATH

breathcleanse

TECHNOLOGY

NET WT 3.4 OZ (96.4 g)

Parodontax Active Gum Repair Breath Freshener 3.4 oz
Parodontax Active Gum Repair Breath Freshener 3.4 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN6
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD6
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY6
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY6
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0737-01parodontaxActive Gum Repair Breath Freshener96.4 g in 1 TUBEPASTE96.46
0135-0737-01parodontaxActive Gum Repair Breath Freshener1 in 1 CARTONPASTE16
0135-0737-02parodontaxActive Gum Repair Breath Freshener23 g in 1 TUBEPASTE236
0135-0737-02parodontaxActive Gum Repair Breath Freshener1 in 1 CARTONPASTE16
0135-0737-03parodontaxActive Gum Repair Breath Freshener65 g in 1 TUBEPASTE656
0135-0737-03parodontaxActive Gum Repair Breath Freshener1 in 1 CARTONPASTE16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-07370135-0737-01, 0135-0737-02, 0135-0737-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
STANNOUS FLUORIDE3FTR44B32QACTIM
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ZINC CHLORIDE86Q357L16BIACT
CARRAGEENAN5C69YCD2YJIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
parodontax Active Gum Repair Breath FreshenerSTANNOUS FLUORIDEHaleon US Holdings LLCaddcb1e2-24b9-4367-adf3-6806e2439a802025-12-22WarningsExact identifier
ndc (package): 0135-0737-01
ndc (package): 0135-0737-02
ndc (package): 0135-0737-03
ndc (product): 0135-0737
ndc11 (package): 00135073702
ndc11 (package): 00135073701
ndc11 (package): 00135073703
spl id: 8d02125c-336e-4b68-a49d-1cffd670ed6b
spl set id: addcb1e2-24b9-4367-adf3-6806e2439a80

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.