FDA.reportPublic FDA data

AQUAFRESH

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-05
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 00:09:26

Label at a glance#

ProductAQUAFRESH SENSITIVE MAXIMUM STRENGTH
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure9 sections

Indications and uses

• aids in the prevention of dental cavities. • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

Dosage and administration

• adults and children 12 years of age and older: o apply at least a 1-inch strip of the product onto a soft bristle toothbrush. o brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. • children under 12 years of age:...

Storage and handling

• store below 30°C (86°F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate (5%)*

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

*maximum FDA sensitivity active ingredient

Purpose

OTC - PURPOSE SECTION

Antihypersensitivity

Anticavity

Uses

INDICATIONS & USAGE SECTION

  • aids in the prevention of dental cavities.
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

Warnings

WARNINGS SECTION

When using this product,

OTC - WHEN USING SECTION

if irritation occurs discontinue use.

Stop use and ask a dentist if

OTC - STOP USE SECTION

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
  • pain/sensitivity still persists after 4 weeks of use.

Keep out of reach of children.

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 12 years of age and older:
    • apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
  • children under 12 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, sodium lauryl sulfate, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide, menthol, 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 0135-0605-01

Aquafresh®

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

triple protection®

DENTIST RECOMMENDED ACTIVE INGREDIENTS

maximum strength* sensitive

Sugar Acid Protection**

from Fluoride

  • healthy gums†
  • strong teeth
  • fresh breath

smooth mint

NET WT 5.6 OZ (158.8 g)

Aquafresh® Maximum Strength* Sensitive toothpaste cares for your mouth, helping you keep it healthy and happy. With regular use, you can once again enjoy your favorite foods without the nagging pain of sensitive teeth.

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

targets the source of Sensitive tooth pain, soothes the nerves and reduces painful sensitivity

†with twice daily brushing

ALWAYS FOLLOW THE LABEL

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

GSK Consumer Healthcare Warren, NJ 07059

*maximum FDA sensitivity active ingredient

©2015 GSK or its licensor.

105481XA

C:\Users\sh821028\Pictures\105481XA_Aquafresh Sensitive Maximum Strength_5_6oz_cartion.
C:\Users\sh821028\Pictures\105481XA_Aquafresh Sensitive Maximum Strength_5_6oz_cartion.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN13
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD13
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY13
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY13
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY13
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY13
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY13

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0605-01AQUAFRESHSENSITIVE MAXIMUM STRENGTH158.8 g in 1 TUBEPASTE158.813
0135-0605-01AQUAFRESHSENSITIVE MAXIMUM STRENGTH1 in 1 CARTONPASTE113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0605AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]13Current NDC, Legacy NDC, 2 package rows20240307_76adbccb-0812-4407-a6fc-a57e6f144fbb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0605-01GM - Gram0135-06059ab66894-b0d9-476f-9512-d5dce913cf6a12021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0Z5
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W75
FLUORIDE IONACTIVE MOIETYQ80VPU408O5
NITRATE IONACTIVE MOIETYT93E9Y28445
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69335
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808B5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD5
GLYCERININACTIVE INGREDIENTPDC6A3C0OX5
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P95
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J5
SORBITOLINACTIVE INGREDIENT506T60A25R5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP5
WATERINACTIVE INGREDIENT059QF0KO0R5
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE5

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
0135-06050135-0605-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM HYDROXIDE55X04QC32IIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
D&C RED NO. 302S42T2808BIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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 1 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii+dosage form
2 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BCAPSULE / ORAL0.1 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPASTE / DENTAL0.6 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BCAPSULE / ORAL0.1 mgExact identifier — unii candidate
14 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / DENTAL0.3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, COATED / ORAL1.16 mgExact identifier — unii candidate
14 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, CHEWABLE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
14 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET / ORAL19 mgExact identifier — unii candidate
14 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, CHEWABLE / ORAL3 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPASTE / DENTAL0.6 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, CHEWABLE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
14 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET / ORAL19 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE / DENTAL1.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
14 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, FILM COATED / ORAL0.26 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE / DENTAL1.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, CHEWABLE / ORAL3 mgExact identifier — unii candidate
14 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
14 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, FILM COATED / ORAL0.26 mgExact identifier — unii candidate
14 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 30D&C RED NO. 302S42T2808BTABLET, COATED / ORAL1.16 mgExact identifier — unii candidate
14 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 SENSITIVE MAXIMUM STRENGTHPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC76adbccb-0812-4407-a6fc-a57e6f144fbb2024-03-05WarningsExact identifier
ndc (package): 0135-0605-01
ndc (product): 0135-0605
ndc11 (package): 00135060501
spl id: 0e988328-62da-43e7-98b3-5d94a4cd6684
spl set id: 76adbccb-0812-4407-a6fc-a57e6f144fbb

Reported adverse events (FAERS/openFDA)#

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