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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Gum Therapy Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCed6889b6-58db-41cf-e053-2a95a90a7de22024-11-11WarningsExact identifier
application number: M022
Listerine FreshBurst AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC62b5c3ee-01cc-4c4e-9f28-e7dafa7372d82024-11-11WarningsExact identifier
application number: M022
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLCdd3729c2-fd05-4db0-a542-487bb0f9001f2024-11-11WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC9e97e4f8-80c2-44e0-862c-0dfca392a4362024-11-11WarningsExact identifier
application number: M022
Orajel 2X Medicated GelORAL PAIN RELIEVERChurch & Dwight Co., Inc.262be295-4eaf-3136-e063-6294a90a7dcc2024-11-05WarningsExact identifier
application number: M022
BIOTENE Fresh Mint OriginalSODIUM FLUORIDEHaleon US Holdings LLC1101c17f-c848-4cd5-a7cd-679b59dbe1bf2024-11-05WarningsExact identifier
application number: M022
bioteneSODIUM MONOFLUOROPHOSPHATEHaleon US Holdings LLCa47a6502-efb2-4072-9562-cbe293531c2b2024-11-04WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser CherrySODIUM PERBORATE MONOHYDRATEVintage Brands Limiteda0e145c8-6b08-40be-ae4f-5678c4a78b1e2024-10-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33b-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33a-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043a3cb4-f560-0ffd-e063-6394a90a2ff62024-10-29WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser MintSODIUM PERBORATE MONOHYDRATEVintage Brands Limitedbe57ca56-834f-4170-a407-f193484d8b0a2024-10-29WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean MintSODIUM FLUORIDEHaleon US Holdings LLC817c0dad-d109-428e-adb5-3354604acc942024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC1f3d68f6-afd6-42e7-b3e5-210228c8e7de2024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals LLC0dd15227-6603-42ac-9a5f-f2dc49e0382a2024-10-28Warnings, Adverse reactionsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0605d5d6-82bd-415e-b5cb-e273f934a4a72024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCf70fa3fc-cd65-4a80-9efd-129e98fd39982024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief MentholPHENOLChain Drug Consortiumaf661ef0-cdc3-4146-8ae5-59795aa496502024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLChain Drug Consortiuma9cf9829-4b70-44fa-9719-240b65c067242024-10-28WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEPHARMACY VALUE ALLIANCE, LLC85ae80c1-2bc2-4c90-9559-63510d03e7392024-10-28WarningsExact 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