FDA.reportPublic FDA data

Advance White Extreme Whitening

Product NDC
10237-658
11-digit product format
102370658
Labeler code
10237
Product ID
10237-658_44fa11f4-4ddd-e970-e063-6394a90a307e
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-29
Substance
SODIUM FLUORIDE
Active strength
2.4 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Advance White Extreme Whitening
Brand name suffix
Tartar Control
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2.4 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-658-09Advance White Extreme WhiteningTartar Control1 in 1 CARTONPASTE, DENTIFRICE113
10237-658-09Advance White Extreme WhiteningTartar Control25 g in 1 TUBEPASTE, DENTIFRICE2513
10237-658-12Advance White Extreme WhiteningTartar Control2 in 1 CARTONPASTE, DENTIFRICE213
10237-658-12Advance White Extreme WhiteningTartar Control340 g in 1 TUBEPASTE, DENTIFRICE34013
10237-658-28Advance White Extreme WhiteningTartar Control2 in 1 CARTONPASTE, DENTIFRICE213
10237-658-28Advance White Extreme WhiteningTartar Control2 in 1 PACKAGEPASTE, DENTIFRICE213
10237-658-43Advance White Extreme WhiteningTartar Control121 g in 1 TUBEPASTE, DENTIFRICE12113
10237-658-43Advance White Extreme WhiteningTartar Control1 in 1 CARTONPASTE, DENTIFRICE113
10237-658-46Advance White Extreme WhiteningTartar Control1 in 1 CARTONPASTE, DENTIFRICE113
10237-658-46Advance White Extreme WhiteningTartar Control4 in 1 PACKAGEPASTE, DENTIFRICE413
10237-658-60Advance White Extreme WhiteningTartar Control170 g in 1 TUBEPASTE, DENTIFRICE17013
10237-658-60Advance White Extreme WhiteningTartar Control1 in 1 CARTONPASTE, DENTIFRICE113
10237-658-72Advance White Extreme WhiteningTartar Control204 g in 1 TUBEPASTE, DENTIFRICE20413
10237-658-72Advance White Extreme WhiteningTartar Control1 in 1 CARTONPASTE, DENTIFRICE113

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ADVANCE WHITE EXTREME WHITENING TARTAR CONTROL (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OADVANCE WHITE EXTREME WHITENING TARTAR CONTROL (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
POLOXALENEINACTIVE INGREDIENTV8B3K56SW0ADVANCE WHITE EXTREME WHITENING TARTAR CONTROL (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQADVANCE WHITE EXTREME WHITENING TARTAR CONTROL (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYADVANCE WHITE EXTREME WHITENING TARTAR CONTROL (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ADVANCE WHITE EXTREME WHITENING TARTAR CONTROL (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOADVANCE WHITE EXTREME WHITENING TARTAR CONTROL (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SODIUM LAUROYL SARCOSINATEINACTIVE INGREDIENT632GS99618ADVANCE WHITE EXTREME WHITENING TARTAR CONTROL (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JADVANCE WHITE EXTREME WHITENING TARTAR CONTROL (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SODIUM PERCARBONATEINACTIVE INGREDIENTZ7G82NV92PADVANCE WHITE EXTREME WHITENING TARTAR CONTROL (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZADVANCE WHITE EXTREME WHITENING TARTAR CONTROL (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RADVANCE WHITE EXTREME WHITENING TARTAR CONTROL (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-658ADVANCE WHITE EXTREME WHITENING TARTAR CONTROL (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]12Current NDC, Legacy NDC, 14 package rows20240530_b539264f-e1ff-440b-af76-84266fe2c0a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNb539264f-e1ff-440b-af76-84266fe2c0a213
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDb539264f-e1ff-440b-af76-84266fe2c0a213
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYb539264f-e1ff-440b-af76-84266fe2c0a213
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYb539264f-e1ff-440b-af76-84266fe2c0a213
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYb539264f-e1ff-440b-af76-84266fe2c0a213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-658-09102370658091 TUBE in 1 CARTON (10237-658-09) / 25 g in 1 TUBE1 tube2012-01-290000-00-00NoNoCurrent
10237-658-12102370658122 TUBE in 1 CARTON (10237-658-12) / 340 g in 1 TUBE2 tube2019-09-232024-12-31NoNoCurrent
10237-658-28102370658282 CARTON in 1 PACKAGE (10237-658-28) / 2 TUBE in 1 CARTON / 204 g in 1 TUBE2 carton2024-06-03NoNoCurrent
10237-658-43102370658431 TUBE in 1 CARTON (10237-658-43) / 121 g in 1 TUBE1 tube2012-01-290000-00-00NoNoCurrent
10237-658-46102370658464 CARTON in 1 PACKAGE (10237-658-46) / 1 TUBE in 1 CARTON / 170 g in 1 TUBE4 carton2022-04-26NoNoCurrent
10237-658-60102370658601 TUBE in 1 CARTON (10237-658-60) / 170 g in 1 TUBE1 tube2012-01-290000-00-00NoNoCurrent
10237-658-72102370658721 TUBE in 1 CARTON (10237-658-72) > 204 g in 1 TUBE1 tube2012-01-292024-12-31NoNoCurrent