FDA.reportPublic FDA data

AQUAFRESH

Product NDC
0135-0234
11-digit product format
001350234
Labeler code
0135
Product ID
0135-0234_4af3766f-39a7-abd8-e063-6294a90ad4a7
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-03-25
Substance
SODIUM FLUORIDE
Active strength
1.13 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
EXTREME CLEAN WHITENING ACTION
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.13 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1044547Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aaff19d9-4ba5-462a-893b-7220feb25d6cAvailable on FDA.report

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

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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7AQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
FLUORIDE IONACTIVE MOIETYQ80VPU408OAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9AQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
POTASSIUM PYROPHOSPHATEINACTIVE INGREDIENTB9W4019H5GAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
SODIUM TRIPOLYPHOSPHATEINACTIVE INGREDIENT5HK03SA80JAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
SORBITOLINACTIVE INGREDIENT506T60A25RAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
WATERINACTIVE INGREDIENT059QF0KO0RAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BAQUAFRESH TARTAR CONTROL WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN FRESHENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X ENAMEL (SODIUM FLUORIDE) PASTE AQUAFRESH ADVANCED 2X WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH PURE BREATH ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN REVITALIZING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH WHITENING MULTI ACTION (SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0234AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]22Current NDC, Legacy NDC, 6 package rows20240125_aaff19d9-4ba5-462a-893b-7220feb25d6c.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 9 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wintergreen PeppermintPOTASSIUM NITRATE, SODIUM FLUORIDETwice Twice LLC7b7beec2-e070-4102-a2a4-68c332fc9fb32026-01-19WarningsExact identifier
application number: M022
GuruNanda SensitivePOTASSIUM NITRATEGURUNANDA, LLC3ef0d3d4-fd42-0181-e063-6394a90af09c2026-01-19WarningsExact identifier
application number: M022
Up and Up AntisepticCETYLPYRIDINIUM CHLORIDETarget Corporation386ee9f9-598e-ad00-e063-6394a90aeb462026-01-19WarningsExact identifier
application number: M022
Colgate Sensitive Complete ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company4a8f1d2f-b326-46d2-8914-d65ccc409edf2026-01-18WarningsExact identifier
application number: M022
Colgate Sensitive WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company3b656928-af58-4ee9-8fb8-360688eb9bf32026-01-13WarningsExact identifier
application number: M022
Colgate Sensitive Enamel HealthPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Companya50d4259-8a79-417e-b381-72c7a8ec04182026-01-13WarningsExact identifier
application number: M022
Walgreens Sensitive Enamel RepairSODIUM FLUORIDEWalgreens41d6384d-695b-b60b-e063-6394a90aa0b92026-01-09WarningsExact identifier
application number: M022
HyVee Throat Drops Lemon MintMENTHOLHY-VEE, INC47f738cc-7968-cc07-e063-6294a90af7ab2026-01-09WarningsExact identifier
application number: M022
CVS Health Clinical White Stain ProtectorSODIUM FLUORIDECVS Pharmacy41d5c3a9-abe5-5528-e063-6294a90ada792026-01-09WarningsExact identifier
application number: M022
CVS Health Sensitive Enamel RepairSODIUM FLUORIDECVS41d547b3-2feb-8e83-e063-6294a90ae3cd2026-01-09WarningsExact identifier
application number: M022
Moon Platinum Advanced Whitening AnticavitySODIUM FLUORIDEMoon Oral Care LLCded3a5a6-2883-f3de-e053-2a95a90afb942026-01-09WarningsExact identifier
application number: M022
Moon Whitening AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0bdcad3e-b8e9-bd91-e063-6394a90a666a2026-01-09WarningsExact identifier
application number: M022
Colgate Sensitive Prevent and RepairPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Companye67410dc-a671-4611-8af1-097be071cd1c2026-01-09WarningsExact identifier
application number: M022
Colgate Sensitive plus WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company2092c747-e025-47a9-9e54-731631d3c8312026-01-09WarningsExact identifier
application number: M022
Dentemp Canker CoverCANKER COVERDOC Brands2e7fbf9d-553c-c7bf-e063-6294a90a5f792026-01-08WarningsExact identifier
application number: M022
HyVee Throat Drops Lemon MintMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.47e2650f-4f50-8d85-e063-6394a90a1ddc2026-01-08WarningsExact identifier
application number: M022
Dentemp Canker CoverCANKER COVERDOC Brands2b4b22e9-a03b-fb8f-e063-6394a90a87472026-01-08WarningsExact identifier
application number: M022
Crest 3D White AdvancedSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Companyf3aa9a59-b4d4-05d9-e053-2995a90a0aea2026-01-08Exact identifier
application number: M022
Oral B Plaque Defense Special Care Oral RinseCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd503fad5-a378-0e60-e053-2a95a90abe652026-01-08WarningsExact identifier
application number: M022
Scope All Day CPC Antigingivitis/Antiplaque Mouthwash All DayCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Companyd5f69341-b659-c74a-e053-2a95a90a317e2026-01-08WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044547sodium fluoride 0.25 % ToothpastePSNaaff19d9-4ba5-462a-893b-7220feb25d6c23
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCDaaff19d9-4ba5-462a-893b-7220feb25d6c23
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSYaaff19d9-4ba5-462a-893b-7220feb25d6c23
1044547sodium fluoride 0.25 % ToothpasteSYaaff19d9-4ba5-462a-893b-7220feb25d6c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0234-06001350234061 TUBE in 1 CARTON (0135-0234-06) / 158.7 g in 1 TUBE1 tube2011-03-250000-00-00NoNoCurrent
0135-0234-08001350234082 TUBE in 1 CARTON (0135-0234-08) / 158.7 g in 1 TUBE2 tube2011-03-250000-00-00NoNoCurrent
0135-0234-09001350234093 TUBE in 1 CARTON (0135-0234-09) / 158.8 g in 1 TUBE3 tube2021-02-28NoNoCurrent