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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage10237-65810237-658-72DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 17 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0510237-658-72d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2610237-658-72f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2610237-658-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3110237-658-722ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3110237-658-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2810237-658-72a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2810237-658-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2110237-658-72cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2110237-658-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1010237-658-72cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1010237-658-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3110237-658-72302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3110237-658-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2010237-658-72ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2010237-658-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1010237-658-720efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1010237-658-120efc9e666f02…f202fb6c5f17…

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 · 1,037 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
Anticavity Fluoride RinseSODIUM FLUORIDENice-Pak Products, LLCc71d4064-f938-477b-9346-eb38be65390d2026-08-25Warnings, Adverse reactionsExact identifier
application number: M021
AIM Whitening with Baking SodaSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fd0b4-33ba-5764-e054-00144ff88e882026-08-25WarningsExact identifier
application number: M021
OPTIC WHITE PRO SERIES VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyb1ada157-a9a0-4eec-83a2-6e448d7f12dc2026-08-21WarningsExact identifier
application number: M021
Colgate Max Fresh Clean MintSODIUM FLUORIDEColgate-Palmolive Company7cb85fc4-573b-45d7-a430-f2fd17320c432026-08-21WarningsExact identifier
application number: M021
Therabreath WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.3ba04b55-38f9-76f3-e063-6394a90a3c032026-08-21WarningsExact identifier
application number: M021
Therabreath Deep CleanSTANNOUS FLUORIDEChurch & Dwight Co., Inc.3c372f26-e0c4-0659-e063-6294a90ae9f92026-08-21WarningsExact identifier
application number: M021
TheraBreathPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.4b812a38-f7cb-51c8-e063-6394a90ab82c2026-08-21WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchangeseb95e0ca-a94c-41cb-9f54-6c64ed9a97332026-08-21Warnings, Adverse reactionsExact identifier
application number: M021
Pop On Toothpaste.POP ON TOOTHPASTE.POPONSMILES,LLC4a0edab5-ae36-91b5-e063-6294a90aa6852026-08-21WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES EXPRESS WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company188dc3ac-64c9-438e-858b-846f725c6ea02026-08-21WarningsExact identifier
application number: M021
freshSTART Anticavity fluoride toothpaste.ANTICAVITY FLUORIDE TOOTHPASTEGuangzhou Xinuo Technology Co., Ltd.596432d5-3541-6dff-e063-6294a90a9d422026-08-19WarningsExact identifier
application number: M021
COLGATE 2IN1 WHITENING STAIN LIFTERSSODIUM FLUORIDEColgate-Palmolive Company26f1f873-06b2-45ef-a4b9-32f997642bc72026-08-17WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIES HI WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company8b210b6c-b712-4f14-906c-306922573a262026-08-17WarningsExact identifier
application number: M021
SprinJene NaturalSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corpe64cecc3-0845-4bdf-a449-d78248791ccf2026-08-17WarningsExact identifier
application number: M021
ATOMY ANTICAVITY TOOTHSODIUM MONOFLUOROPHOSPHATEATOMY CO., LTD.592caccc-e3a9-9c66-e063-6394a90a26e32026-08-16WarningsExact identifier
application number: M021
SprinJene Health BoostSODIUM MONOFLUOROPHOSPHATEHealth and Natural Beauty USA Corp9be87bcd-403a-4d7e-8ded-9833249565d12026-08-14WarningsExact identifier
application number: M021
SprinJene Fresh BoostSODIUM FLUORIDEHealth and Natural Beauty USA Corp919f6f51-6c43-4f1c-9bc7-029bf76c0e682026-08-14WarningsExact identifier
application number: M021
SprinJene Natural Sensitivity ReliefSODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATEHealth and Natural Beauty USA Corp32cc5bc2-60c9-4cb4-acde-485ae494aba22026-08-14WarningsExact 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 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