AIM

Product NDC
10237-630
Requested package NDC
10237-630-45
11-digit product format
102370630
Labeler code
10237
Product ID
10237-630_5593d974-6d63-d952-e063-6394a90af155
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-11-10
Substance
SODIUM FLUORIDE
Active strength
2.4 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
AIM
Brand name suffix
Cavity Protection with Whitening
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
a8c742e1-ee61-4593-b8f5-b9e586d39dfcAvailable on FDA.report

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7AIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311AIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9AIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2
MICAINACTIVE INGREDIENTV8A1AW0880AIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2
PEG-32 STEARATEINACTIVE INGREDIENT33GX5WQC0MAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RAIM CAVITY PROTECTION WITH WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2

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 48 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.13910b55-9b5d-af53-e063-6294a90acf5d2024-03-13WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitudee3bb60f8-2a06-42d6-a182-8c31bb982a2a2024-03-01WarningsExact identifier
application number: M021
Maximum SecuritySODIUM FLUORIDEBob Barker Company Inc.e29f30ec-72ea-4944-a2c2-b1696d31b6392024-02-27WarningsExact identifier
application number: M021
Made by Dentists For Kids Monster Slime Sour AppleSODIUM FLUORIDEMADE BY DENTISTS INCdfddc67c-3626-48c4-8120-bcc6c455d1192024-02-23WarningsExact identifier
application number: M021
Orajel Gabbys DollhouseSODIUM FLUORIDEChurch & Dwight Co., Inc.cd47bd1e-44ac-465f-8529-6073ade147062024-02-23WarningsExact identifier
application number: M021
Colgate Kids Maximum Cavity ProtectionSODIUM FLUORIDEColgate-Palmolivec44c7a7e-fc3e-a81b-1961-ff89614b678f2024-02-22WarningsExact identifier
application number: M021
TheraBreath Fresh Breath Anticavity Mild MintSODIUM FLUORIDEChurch & Dwight Co., Inc.19ce5324-7d8d-4d70-ad9b-238f7e612eac2024-02-06WarningsExact identifier
application number: M021
Nature Mint AnticavitySODIUM MONOFLUOROPHOSPHATEBob Barker Company Inc.916891d3-5234-46a8-a492-21a31f36a8522024-02-02WarningsExact identifier
application number: M021
Treatment Rinse MintANTICARIESDENTAL ALLIANCE HOLDINGS LLCf1255065-b7c3-4eb6-e053-2995a90afcdb2024-01-31WarningsExact identifier
application number: M021
Maintenance Rinse MintANTICARIESDental Alliance Holdings LLCf1273510-aa83-3ef9-e053-2a95a90aea272024-01-31WarningsExact identifier
application number: M021
ATOMY PROPOLIS TOOTHPAS TE 50GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98d839e3-a1aa-c83d-e053-2995a90a7e792024-01-30WarningsExact identifier
application number: M021
ATOMY PROPOLIS TOOTHPAS TE 200GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98aebbec-aec0-1478-e053-2a95a90a03ea2024-01-30WarningsExact identifier
application number: M021
Toms Childrens Anticavity Mouthwash Silly StrawberrySODIUM FLUORIDETom's of Maine, Inc.998c6f35-20f4-4cb8-bc48-6aa39e61481a2024-01-18WarningsExact identifier
application number: M021
Gel-Kam Fruit and BerrySTANNOUS FLUORIDEColgate Oral Pharmaceuticals, Inc.8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c2024-01-18WarningsExact identifier
application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.9a976ac8-d966-4d94-93da-45652f2d24812024-01-12WarningsExact identifier
application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint FluorideSODIUM FLUORIDEColgate Oral Pharmaceuticals, Inc.2b4b6f9a-0e31-4891-8721-d1b9a58cca962024-01-12WarningsExact identifier
application number: M021
Colgate MaxFresh with Mini Breath Cool MintSODIUM FLUORIDEColgate-Palmolive Company51abd6bc-7a3d-4b0e-a810-af9e949264382024-01-09WarningsExact identifier
application number: M021
Colgate Enamel Strength MouthwashSODIUM FLUORIDEColgate-Palmolive - do not usef0cca38b-c0a3-4788-8cca-727a5684c16b2024-01-09WarningsExact identifier
application number: M021
PerCara Oral Health Rinse Fresh MintCETYLPYRIDINIUM CHLORIDELEC Custom Products, Incbd98c654-218b-15ac-e053-2a95a90a75d12024-01-01WarningsExact identifier
application number: M021
PerCara Kids Bubble GumSODIUM FLUORIDELEC Custom Products, Inc.be3a7272-acfb-7d14-e053-2995a90a94202024-01-01WarningsExact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-630-45102370630451 TUBE in 1 CARTON (10237-630-45) / 127 g in 1 TUBE1 tube2026-07-01NoNoCurrent