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 8 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sore Mouth CleanserHYDROGEN PEROXIDEMeijer, Inc.c9c17224-9304-403a-b6a1-9c8bd94e3d942026-02-19Warnings, Adverse reactionsExact identifier
application number: M022
AQUAFRESH CAVITY PROTECTIONSODIUM FLUORIDEHaleon US Holdings LLC5484999c-8e6f-430d-99a5-6893a24894672026-02-16WarningsExact identifier
application number: M022
AQUAFRESH EXTREME CLEAN WHITENING ACTIONSODIUM FLUORIDEHaleon US Holdings LLCaaff19d9-4ba5-462a-893b-7220feb25d6c2026-02-16WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLWalgreen Co.55807b18-42ed-45a7-845e-fcf7f5d70d042026-02-12Warnings, Adverse reactionsExact identifier
application number: m022
Sore Mouth CleanserHYDROGEN PEROXIDEWalgreen Co.33223589-4ff4-4e4e-96da-6fa2e4d0f1872026-02-12Warnings, Adverse reactionsExact identifier
application number: M022
PERIOSCIENCES SENSITIVE AO ProPOTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATEPERIOSCIENCES LLCacca8964-b575-468c-8b40-514dfbf507782026-02-09WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLRetail Business Services, LLCd46546d0-c6df-431a-8ab0-bc5013c084d72026-02-06Warnings, Adverse reactionsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)e19228e9-6f87-456e-a222-f979a234d5892026-02-06WarningsExact identifier
application number: M022
Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC49d28991-b68f-ba16-e063-6394a90a0b132026-02-02WarningsExact identifier
application number: M022
Sootheez Strawberry LemonadePECTINPrimrose Candy Co.49e2b303-1018-cd13-e063-6394a90ae3002026-02-02WarningsExact identifier
application number: M022
Sootheez Berry LemonadePECTINPrimrose Candy Co.49cee56f-c45f-6c79-e063-6294a90a5f8f2026-02-01WarningsExact identifier
application number: M022
Sore Mouth CleanserHYDROGEN PEROXIDERite Aid Corporation294418aa-640d-42be-ad07-de31da7a7ccc2026-01-30Warnings, Adverse reactionsExact identifier
application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Incaa61ce6f-8336-4071-93b8-549fd22d1ae02026-01-22WarningsExact identifier
application number: M022
Colgate Sensitive Complete ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company866067b9-3dce-492d-ae99-1b807ecd56ff2026-01-22WarningsExact identifier
application number: M022
Family Wellness Pain ReliefBENZOCAINE 20%FAMILY DOLLAR (Family Wellness)92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea2026-01-21WarningsExact identifier
application number: M022
Crest Pro-Health All Day Clean BreathCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company48eaca4c-19c2-2dd2-e063-6394a90a3e082026-01-21WarningsExact identifier
application number: M022
Betadine GarglePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.5f0a3377-1398-2603-c632-f0d214bb88ec2026-01-21WarningsExact identifier
application number: M022
ORAL PAIN RELIEFBENZOCAINEUniversal Distribution Center LLCe276ba37-46fb-4ed9-9ee1-c08a2a89704a2026-01-20WarningsExact identifier
application number: M022
Equate Orasol20% BENZOCAINEWAL-MART STORES INC.08404780-8252-4484-b1c3-8970803f74f82026-01-19WarningsExact identifier
application number: M022
Equate Healthy MouthCPC 0.05% ANTIPLAQUE/ANTI-GINGIVITISWalmart, Inc.1cc1f6fd-67d4-b314-e063-6294a90ab9952026-01-19WarningsExact 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