FDA.reportPublic FDA data

Essentials Whiten and Strengthen

Product NDC
10237-672
11-digit product format
102370672
Labeler code
10237
Product ID
10237-672_574c33d0-d6f6-187e-e063-6394a90a9bf4
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride 0.24%
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-01
Substance
SODIUM FLUORIDE
Active strength
2.4 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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 packagepackage10237-67210237-672-09DDiscontinued by firm2026-10-05

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 · 10 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

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
Essentials Whiten and Strengthen
Listing expiration
2027-12-31

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
96548550-2cd1-b757-e053-2995a90a15eaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-672-09Essentials Whiten and Strengthen1 in 1 CARTONPASTE, DENTIFRICE14
10237-672-09Essentials Whiten and Strengthen25 g in 1 TUBEPASTE, DENTIFRICE254
10237-672-43Essentials Whiten and Strengthen121 g in 1 TUBEPASTE, DENTIFRICE1214
10237-672-43Essentials Whiten and Strengthen1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-672ESSENTIALS WHITEN AND STRENGTHEN (SODIUM FLUORIDE 0.24%) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]4Current NDC, Legacy NDC, 4 package rows20241027_96548550-2cd1-b757-e053-2995a90a15ea.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 32 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Total Care Kids Anticavity Fluoride Rinse - Berry SplashSODIUM FLUORIDEKenvue Brands LLC28986d7f-3e9a-8dfb-e063-6394a90a731e2025-12-10WarningsExact identifier
application number: M021
Toms of Maine Tropical IslandALUMINUM CHLOROHYDRATEColgate-Palmolive Company0d6c51bc-5391-4533-b4fd-961dc4f363422025-12-10WarningsExact identifier
application number: M021
Business Class KitSODIUM MONOFLUOROPHOSPHATEAmerican Airlines, Inc.483d7aec-34ac-49c5-ac0e-8fba5b4737ae2025-12-09WarningsExact identifier
application number: M021
Colgate Anticavity KitSODIUM MONOFLUOROPHOSPHATEMing Fai Industrial (Shenzhen) Co. Ltd121decce-c364-4060-87da-0c6a6cd484742025-12-08WarningsExact identifier
application number: M021
First Class KitSODIUM MONOFLUOROPHOSPHATEAmerican Airlines, Inc.ba717de8-c3a2-41bf-85a1-aa75f9744d302025-12-08WarningsExact identifier
application number: M021
United Airlines Business Class KitSODIUM MONOFLUOROPHOSPHATEUnited Airlines94c5e9a4-19f3-4590-9da4-313c752612312025-12-08WarningsExact identifier
application number: M021
Dr. Jen SuperPaste Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC5f08d994-e458-42b2-aa39-e84fca3acf482025-12-05WarningsExact identifier
application number: M021
Colgate Anticavity KitSODIUM MONOFLUOROPHOSPHATEMing Fai Industrial (Shenzhen) Co. Ltd86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec2025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC8b28b857-9162-4065-b0a0-571efffe97872025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste OrthoSODIUM FLUORIDEDr Jen Natural, LLC9dd248bf-9488-43cd-a041-e8315a05ce5d2025-12-04WarningsExact identifier
application number: M021
Dr. Jen SuperPaste PerioSODIUM FLUORIDEDr Jen Natural, LLC8c7e6d3a-49d9-4098-9d5e-e9792b3735742025-12-04WarningsExact identifier
application number: M021
Colgate Total Plaque CleanseSTANNOUS FLUORIDEColgate-Palmolive Companyb2980238-5bcb-467f-9e90-a307938632c22025-12-03WarningsExact identifier
application number: M021
Advance White Extreme Whitening Tartar ControlSODIUM FLUORIDEChurch & Dwight Co., Inc.b539264f-e1ff-440b-af76-84266fe2c0a22025-12-02WarningsExact identifier
application number: M021
Sensodyne Pronamel Clinical Enamel Strength Fresh BreathPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC34a1a32e-3017-f018-e063-6394a90a02302025-12-01WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc77e51d6f-c1a2-4650-b3dd-5e4552379e772025-12-01WarningsExact identifier
application number: M021
Freshmint SensitivePOTASSIUM NITRATE AND SODIUM FLUORIDENew World Imports, Incaa2e0864-3325-4acf-a2c5-0eb27eb18baf2025-12-01WarningsExact identifier
application number: m021
PRO-SYSSODIUM FLUORIDE AND POTASSIUM NITRATEBenco Dental4e470ba4-60bb-1815-e063-6294a90abacc2025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDEBenco Dental4e539cb2-bcbd-95fc-e063-6294a90a21212025-12-01WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDONG IL PHARMS CO., LTD.44763bf6-caf3-ec69-e063-6394a90a0ee12025-11-25WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD44765e86-2eb2-6381-e063-6394a90a761f2025-11-25WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN96548550-2cd1-b757-e053-2995a90a15ea4
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD96548550-2cd1-b757-e053-2995a90a15ea4
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY96548550-2cd1-b757-e053-2995a90a15ea4
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY96548550-2cd1-b757-e053-2995a90a15ea4
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY96548550-2cd1-b757-e053-2995a90a15ea4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-672-09102370672091 TUBE in 1 CARTON (10237-672-09) > 25 g in 1 TUBE1 tube2019-12-010000-00-00NoNoCurrent
10237-672-42102370672422 TUBE in 1 CARTON (10237-672-42) / 121 g in 1 TUBE2 tube2026-02-20NoNoCurrent
10237-672-43102370672431 TUBE in 1 CARTON (10237-672-43) / 121 g in 1 TUBE1 tube2019-12-010000-00-00NoNoCurrent
10237-672-44102370672444 CARTON in 1 PACKAGE (10237-672-44) / 1 TUBE in 1 CARTON / 121 g in 1 TUBE4 carton2026-07-03NoNoCurrent