FDA.reportPublic FDA data

AQUAFRESH

Product NDC
0135-0605
11-digit product format
001350605
Labeler code
0135
Product ID
0135-0605_0e988328-62da-43e7-98b3-5d94a4cd6684
Type
HUMAN OTC DRUG
Nonproprietary name
potassium nitrate and sodium fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-02-17
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.1 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
AQUAFRESH
Brand name suffix
SENSITIVE MAXIMUM STRENGTH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038929Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
76adbccb-0812-4407-a6fc-a57e6f144fbbAvailable on FDA.report

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 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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZAQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
FLUORIDE IONACTIVE MOIETYQ80VPU408OAQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
NITRATE IONACTIVE MOIETYT93E9Y2844AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IAQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
SORBITOLINACTIVE INGREDIENT506T60A25RAQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
WATERINACTIVE INGREDIENT059QF0KO0RAQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]5

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

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 37 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENSODYNE Rapid ReliefSTANNOUS FLUORIDEHaleon US Holdings LLCf9589e7c-c5ca-4465-8d37-47ad6c69249f2024-03-06WarningsExact identifier
application number: M022
SENSODYNE Repair and Protect Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLC34260c69-d829-46c0-b12a-5136ee073ba12024-03-06WarningsExact identifier
application number: M022
AQUAFRESH SENSITIVE MAXIMUM STRENGTHPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC76adbccb-0812-4407-a6fc-a57e6f144fbb2024-03-05WarningsExact identifier
application number: M022
ndc (product): 0135-0605
SENSODYNE Advanced WhiteningPOTASSIUM NITRATEHaleon US Holdings LLCa06e2549-3c4e-4818-b53e-1dea6828219f2024-03-04WarningsExact identifier
application number: M022
Sensodyne Extra Whitening Cool MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCc977f2c4-e0f3-44d2-aa7a-845f0583af3e2024-03-04WarningsExact identifier
application number: M022
Sensodyne Natural whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC911ac7e4-2b92-43d5-af0b-b5f741b088fb2024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Healthy WhitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCaca38560-2fd7-47be-9e93-2abc3214e8562024-03-04WarningsExact identifier
application number: M022
Sensodyne Nourish Gently SoothingPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC5403ab67-532c-4bdf-9b06-07b1866f37f12024-03-04WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Active Shield Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCe8684615-f544-4871-b935-0a0f93639d7d2024-03-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Fresh MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC3dfa6827-3aae-4f19-93f6-2ded2faf2ddd2024-03-04WarningsExact identifier
application number: M022
Made by Dentists Sensitive and Whitening Fresh MintPOTASSIUM NITRATE, SODIUM FLUORIDEMADE BY DENTISTS INC0d379c26-69ff-4666-9ad5-7618f0bd139f2024-02-27WarningsExact identifier
application number: M022
Polident ProPartialSTANNOUS FLUORIDEHaleon US Holdings LLC557eeb32-64f4-41e8-ada4-91bd39ae29202024-02-07WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Daily ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCedffce4d-108b-4ffd-9adf-e12cb42ffddd2024-01-24WarningsExact identifier
application number: M022
Peppermint TwistFLUORIDECaldwell Health LLC4b28cdd1-0dba-42f5-a9e8-06d9e75b23962024-01-17WarningsExact identifier
application number: M022
The Natural Dentist Groovy GrapeFLUORIDECaldwell Consumer Health LLC087abbed-1f58-4b45-a76b-a950fa81c18c2024-01-16WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINPharma Nobis, LLCe42fccc2-1b4f-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M022
Sunmark Benzoin Compound TinctureBENZOIN RESINStrategic Sourcing Services LLC0c96d810-83dc-47d3-9a75-63a79feaad0a2023-12-19WarningsExact identifier
application number: M022
Benzoin TinctureBENZOIN RESINHumco Holding Group, Inc.b33b5896-673b-498c-8a58-76ece8552f7a2023-12-15WarningsExact identifier
application number: M022
Povidone IodinePOVIDONE IODINE ORAL RINSE 0.5%Humco Holding Group, Inc.b83dbdd1-ff63-caf8-e053-2a95a90a57642023-12-15WarningsExact identifier
application number: M022
Moon Whitening Gel AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0c556a29-a697-3a66-e063-6394a90abfee2023-12-12WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN76adbccb-0812-4407-a6fc-a57e6f144fbb13
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD76adbccb-0812-4407-a6fc-a57e6f144fbb13
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY76adbccb-0812-4407-a6fc-a57e6f144fbb13
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY76adbccb-0812-4407-a6fc-a57e6f144fbb13
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY76adbccb-0812-4407-a6fc-a57e6f144fbb13
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY76adbccb-0812-4407-a6fc-a57e6f144fbb13
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY76adbccb-0812-4407-a6fc-a57e6f144fbb13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0605-01001350605011 TUBE in 1 CARTON (0135-0605-01) / 158.8 g in 1 TUBE1 tube2017-02-170000-00-00NoNoCurrent