FDA.reportPublic FDA data

Advance White Extreme Whitening

Product NDC
10237-658
Requested package NDC
10237-658-46
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 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
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b539264f-e1ff-440b-af76-84266fe2c0a2Available on FDA.report

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

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 1 of 52 · 1,024 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE CHARCOALSODIUM FLUORIDEColgate-Palmolive Company70ed4a93-b68f-4198-b4b7-7cfeb17ba5d22026-07-30WarningsExact identifier
application number: M021
Colgate Optic White CharcoalSODIUM FLUORIDEColgate-Palmolive Company82ac5b9d-19e8-46ac-a195-c7d85f2967d52026-07-30WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc251264ea-20d2-be19-e063-6394a90aa5f62026-07-29WarningsExact identifier
application number: M021
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
application number: M021
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company76df52a3-b24c-4009-8137-fe644dabebf62026-07-29WarningsExact identifier
application number: M021
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Vividly FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf0551acf-c4d6-4d49-ae9c-4aeaeb99a7002026-07-29WarningsExact identifier
application number: M021
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact identifier
application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company913a2cd6-b6a8-4069-979f-3c696a9bfdf02026-07-24WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PURPLESODIUM FLUORIDEColgate-Palmolive Company16e9b303-fc2a-451a-adc7-dcb10fc0e6f82026-07-23WarningsExact identifier
application number: M021
Orajel Kids SupermanANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.2b47af33-32d4-7c06-e063-6394a90a2f332026-07-23WarningsExact identifier
application number: M021
Sensitive Teeth and GumsPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.935172db-d78f-0c69-e053-2a95a90a0b692026-07-23WarningsExact identifier
application number: M021
Essentials Whiten and StrengthenSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.96548550-2cd1-b757-e053-2995a90a15ea2026-07-23WarningsExact identifier
application number: M021
TP COL OW PurpleSODIUM FLUORIDEColgate-Palmolive Companyea0db59f-f9c0-49a8-9717-69cdf071f6e12026-07-23WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Company00652bb2-090c-4eaa-8fc2-e0be6913a7242026-07-22WarningsExact identifier
application number: M021

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 startSampleExclude flagStatus
10237-658-46102370658464 CARTON in 1 PACKAGE (10237-658-46) / 1 TUBE in 1 CARTON / 170 g in 1 TUBE4 carton2022-04-26NoNoCurrent