AQUAFRESH

Manufacturer
Haleon US Holdings LLC
Effective date
2026-02-16
Label type
HUMAN OTC DRUG LABEL
Version
23
Source
full-release
Hydrated at
2026-06-01 01:46:12

Label at a glance#

ProductAQUAFRESH EXTREME CLEAN WHITENING ACTION
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Dosage and administration

adults and children 2 years 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 establish...

Storage and handling

store below 30°C (86°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride (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 you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Keep out of reach of children under 6 years of age. (Whitening Multi Action only)

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 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 yearsconsult a dentist or doctor

Other information

STORAGE AND HANDLING SECTION

  • store below 30°C (86°F)

Inactive ingredients (whitening action)

INACTIVE INGREDIENT SECTION

water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, sodium lauryl sulfate, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin, synthetic iron oxide, red 30

Inactive ingredients (deep action)

INACTIVE INGREDIENT SECTION

water, hydrated silica, sorbitol, glycerin, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin, iron oxide, red 30

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-800-897-5623(English/Spanish) weekdays

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0234-08

Aquafresh ®

fluoride toothpaste

triple protection ®

EXTREME CLEAN ®

WITH MICRO-ACTIVE FOAMING ACTION

whitening action

Sugar Acid Protection**

from Fluoride

mint blast

helps restore natural whiteness

TWIN VALUE PACK

2 TUBES OF 5.6 OZ (158.7g) EACH

TOTAL NET WT 11.2 OZ (317.4g)

Aquafresh ®Extreme Clean ®Whitening Action toothpaste creates micro-active foam which seeks out hard to reach places in your mouth and fights bad breath. It rinses clear and carefully polishes your teeth so after only one tube you’ll be left with significantly cleaner, smoother, whiter teeth*. Take the Feeling of Clean to the Extreme! ®

Sugar Acid Protection**

**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

*vs a regular toothpaste

ALWAYS FOLLOW THE LABEL

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

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies.

GSKConsumer Healthcare

Warren, NJ 07059

©2015 GSK group of companies

1-800-897-5623

105517XA

C:\Users\jx336321\Pictures\Drug Listing\105517XA_Aquafresh Extreme Clean Whitening Action 0234_2 x 5.6 oz.JPG
C:\Users\jx336321\Pictures\Drug Listing\105517XA_Aquafresh Extreme Clean Whitening Action 0234_2 x 5.6 oz.JPG

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0432-02

Aquafresh ®

fluoride toothpaste

triple protection ®

EXTREME CLEAN ®

WITH MICRO-ACTIVE FOAMING ACTION + WHITENING

deep action

Sugar Acid Protection**

from Fluoride

mint zest

for a whole mouth clean

NET WT 5.6 oz (158.7g)

Aquafresh ®Extreme Clean ®Deep Action toothpaste creates micro-active foam which seeks hard to reach places; in between teeth and even the back of your tongue and rinses clear to leave your teeth clean and smooth. Enjoy a whole mouth clean. 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.

healthy gums*

strong teeth

fresh breath

*with twice daily brushing

ALWAYS FOLLOW THE LABEL

AQUAFRESH, TRIPLE PROTECTION, the iconic Nurdle device are trademarks of the GSK group of companies.

GlaxoSmithKlineConsumer Healthcare, L.P.

Moon Township, PA 15108

©2015 GSK group of companies

We value your feedback

1-800-897-5623

101883XD

Aquafresh Extreme Clean Deep Action 5.6 oz carton
Aquafresh Extreme Clean Deep Action 5.6 oz carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1044547sodium fluoride 0.25 % ToothpastePSN23
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCD23
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSY23
1044547sodium fluoride 0.25 % ToothpasteSY23

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0234-06AQUAFRESHEXTREME CLEAN WHITENING ACTION1 in 1 CARTONPASTE123
0135-0234-06AQUAFRESHEXTREME CLEAN WHITENING ACTION158.7 g in 1 TUBEPASTE158.723
0135-0234-08AQUAFRESHEXTREME CLEAN WHITENING ACTION158.7 g in 1 TUBEPASTE158.723
0135-0234-08AQUAFRESHEXTREME CLEAN WHITENING ACTION2 in 1 CARTONPASTE223
0135-0234-09AQUAFRESHEXTREME CLEAN WHITENING ACTION3 in 1 CARTONPASTE323
0135-0234-09AQUAFRESHEXTREME CLEAN WHITENING ACTION158.8 g in 1 TUBEPASTE158.823
0135-0432-02AQUAFRESHEXTREME CLEAN DEEP ACTION158.7 g in 1 TUBEPASTE158.723
0135-0432-02AQUAFRESHEXTREME CLEAN DEEP ACTION1 in 1 CARTONPASTE123
0135-0432-05AQUAFRESHEXTREME CLEAN DEEP ACTION1 in 1 CARTONPASTE123
0135-0432-05AQUAFRESHEXTREME CLEAN DEEP ACTION22.7 g in 1 TUBEPASTE22.723

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0234-08GM - Gram0135-02345ade2443-0c83-4e6d-a38d-f62e76c321d512017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W711
FLUORIDE IONACTIVE MOIETYQ80VPU408O11
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O693311
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJ11
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX11
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808B11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD11
GLYCERININACTIVE INGREDIENTPDC6A3C0OX11
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P911
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ11
POTASSIUM PYROPHOSPHATEINACTIVE INGREDIENTB9W4019H5G11
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY11
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU11
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR11
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J11
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8Z11
SODIUM TRIPOLYPHOSPHATEINACTIVE INGREDIENT5HK03SA80J11
SORBITOLINACTIVE INGREDIENT506T60A25R11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP11
WATERINACTIVE INGREDIENT059QF0KO0R11
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE11
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16B11

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-02340135-0234-06, 0135-0234-08, 0135-0234-09
0135-04320135-0432-02, 0135-0432-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 244 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, DELAYED RELEASE / ORAL35 mgExact identifier — unii candidate
144 equally ranked IID candidates
ZINC CHLORIDEZINC CHLORIDE86Q357L16BTABLET / ORAL14 mgExact identifier — unii candidate
20 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / ORAL70200 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQEMULSION / TOPICAL1.2 %w/wExact identifier — unii candidate
144 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii+route+dosage form
4 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
144 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUSPENSION / ORAL400 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE / ORAL13440 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION, SOLUTION / INTRAVENOUS24186 mgExact identifier — unii candidate
144 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii+dosage form
4 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, COATED / ORAL1.16 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQLIQUID / TOPICAL1 %w/wExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION, SOLUTION / INTRAVENOUS24186 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET / ORAL193 mgExact identifier — unii candidate
144 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSYRUP / ORAL740 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
144 equally ranked IID candidates
ZINC CHLORIDEZINC CHLORIDE86Q357L16BTABLET / ORAL14 mgExact identifier — unii candidate
20 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, CHEWABLE / ORAL3 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE / ORAL13440 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQOINTMENT / TOPICAL1950 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSYRUP / ORAL740 mgExact identifier — unii candidate
144 equally ranked IID candidates
ZINC CHLORIDEZINC CHLORIDE86Q357L16BSOLUTION/ DROPS / OPHTHALMICNAExact identifier — unii candidate
20 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION, SOLUTION / INTRAMUSCULAR20.3 %w/vExact identifier — unii candidate
144 equally ranked IID candidates
SODIUM PYROPHOSPHATESODIUM PYROPHOSPHATEO352864B8ZPASTE, DENTIFRICE / DENTAL1 %w/wExact identifier — unii+route
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQEMULSION / TOPICAL1.2 %w/wExact identifier — unii candidate
144 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSPONGE / TOPICALNAExact identifier — unii candidate
144 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET / ORAL19 mgExact identifier — unii candidate
28 equally ranked IID candidates
ZINC CHLORIDEZINC CHLORIDE86Q357L16BINJECTION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCONCENTRATE / ORAL3000 mgExact identifier — unii candidate
144 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
28 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJPASTE / DENTAL0.3 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJPASTE / DENTAL0.3 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii candidate
144 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSWAB / TOPICAL5250 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQOINTMENT / TOPICAL1950 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION, SOLUTION / INTRAMUSCULAR20.3 %w/vExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQFILM, SOLUBLE / ORAL29 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, DELAYED RELEASE / ORAL26 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAMUSCULAR406 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSPRAY, METERED / NASAL320 mgExact identifier — unii candidate
144 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUPPOSITORY / RECTAL0.25 mg/mgExact identifier — unii candidate
144 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii candidate
8 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii candidate
144 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
28 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQLOTION / TOPICAL5 %w/wExact identifier — unii candidate
144 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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 WHITENING ACTIONSODIUM FLUORIDEHaleon US Holdings LLCaaff19d9-4ba5-462a-893b-7220feb25d6c2026-02-16WarningsExact identifier
ndc (package): 0135-0432-02
ndc (package): 0135-0234-08
ndc (package): 0135-0234-06
ndc (package): 0135-0432-05
ndc (package): 0135-0234-09
ndc (product): 0135-0234
ndc (product): 0135-0432
ndc11 (package): 00135043202
ndc11 (package): 00135023409
ndc11 (package): 00135023408
ndc11 (package): 00135043205
ndc11 (package): 00135023406
spl id: 4af3766f-39a7-abd8-e063-6294a90ad4a7
spl set id: aaff19d9-4ba5-462a-893b-7220feb25d6c

Reported adverse events (FAERS/openFDA)#

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