Aquafresh

Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:10:50

Label at a glance#

ProductAquafresh Extreme Clean Pure Breath Action
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

adults and children 2 years of age and older: apply toothpaste onto a toothbrush brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing. to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are esta...

Storage and handling

store below 30°C (86°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

  • aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

When using this product,

OTC - WHEN USING SECTION

if irritation occurs discontinue use.

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:
    • apply toothpaste onto a toothbrush
    • brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • 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

STORAGE AND HANDLING SECTION

  • store below 30°C (86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium citrate, sodium saccharin, zinc chloride, iron oxides, red 30, blue 1

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-897-5623

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0604-01

Aquafresh ®

triple protection®

fluoride toothpaste

pure breath action

Sugar Acid Protection**

from Fluoride

EXTREME CLEAN ®

WITH MICRO-ACTIVE FOAMING ACTION + WHITENING

for 80% cleaner, purer breath*

NET WT 5.6 OZ (158.8g )

fresh mint

Aquafresh ®Extreme Clean ®Pure Breath Action toothpaste creates micro-active foam which seeks out hard to reach places and rinses clear to leave your teeth clean and smooth. It neutralizes bad breath odors for 80% cleaner, purer breath.* Take the Feeling of Clean to the Extreme! ®

**With Sugar Acid Protection provided by fluoride, which strengthens enamel, creating a shield that protects the tooth surface against sugar acid attack.

triple protection®

  • healthy gums†
  • strong teeth
  • fresh breath

†with twice daily brushing

*immediately after brushing versus a zinc free toothpaste

ALWAYS FOLLOW THE LABEL

Trademarks are owned by or licensed to the GSK group of companies.

©2015 GSK group of companies or its licensor. All rights reserved.

GSKConsumer Healthcare

Warren, NJ 07059

1-800-897-5623

105483XA

105483XA_Aquafresh Extreme Clean pure breath_5.6 oz.JPG
105483XA_Aquafresh Extreme Clean pure breath_5.6 oz.JPG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044547sodium fluoride 0.25 % ToothpastePSN5
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCD5
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSY5
1044547sodium fluoride 0.25 % ToothpasteSY5

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
0135-0604-01AquafreshExtreme Clean Pure Breath Action158.8 g in 1 TUBEPASTE158.85
0135-0604-01AquafreshExtreme Clean Pure Breath Action1 in 1 CARTONPASTE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0604AQUAFRESH EXTREME CLEAN PURE BREATH ACTION (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC, 2 package rows20240410_462eb309-deca-4464-b13a-7ae314e53ede.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06040135-0604-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
Aquafresh Extreme Clean Pure Breath ActionSODIUM FLUORIDEHaleon US Holdings LLC462eb309-deca-4464-b13a-7ae314e53ede2024-04-08WarningsExact identifier
ndc (package): 0135-0604-01
ndc (product): 0135-0604
ndc11 (package): 00135060401
spl id: 159951ee-7188-6795-e063-6294a90a314d
spl set id: 462eb309-deca-4464-b13a-7ae314e53ede

Reported adverse events (FAERS/openFDA)#

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