FDA.reportPublic FDA data

Colgate Total Enamel Strength

Product NDC
35000-284
11-digit product format
350000284
Labeler code
35000
Product ID
35000-284_a40dd736-4209-4c86-897b-8c7b8781b8a9
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-03
Substance
STANNOUS FLUORIDE
Active strength
1.1 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
Colgate Total Enamel Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416784Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f29c893-e7c5-4a0e-941b-c2634d821147Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-284-63Colgate Total Enamel Strength85 g in 1 TUBEPASTE, DENTIFRICE851
35000-284-63Colgate Total Enamel Strength1 in 1 CARTONPASTE, DENTIFRICE11

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 31 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1ba491f4-2ad2-6e7b-e063-6394a90a9fb72025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188ac743-3ba8-4da4-e063-6294a90a8f872025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b682604-c563-01f1-e063-6294a90ab0bd2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b110db1-fcc0-377f-e063-6394a90a4d442025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1b74ecc4-a1e6-348f-e063-6294a90a58942025-12-11Exact identifier
application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b68315c-6afa-3f37-e063-6294a90a14e82025-12-11WarningsExact identifier
application number: M021
ANTICAVITY FLUORIDESODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD295b88e8-c4b5-c0b0-e063-6394a90aca012025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1b74f072-c33b-c6e2-e063-6394a90ab1e62025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1ba4a807-d6d5-04a0-e063-6294a90ae04d2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b617f4a-b56c-9f75-e063-6294a90a7abe2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b9ec370-eadf-92c4-e063-6294a90a90552025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FALVORSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1eb04296-ecb1-3ccc-e063-6294a90a9bda2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b9e7b21-0d34-74ec-e063-6294a90a1f592025-12-11Exact identifier
application number: M021
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN1f29c893-e7c5-4a0e-941b-c2634d8211471
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD1f29c893-e7c5-4a0e-941b-c2634d8211471
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY1f29c893-e7c5-4a0e-941b-c2634d8211471
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY1f29c893-e7c5-4a0e-941b-c2634d8211471
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY1f29c893-e7c5-4a0e-941b-c2634d8211471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-284-63350000284631 TUBE in 1 CARTON (35000-284-63) / 85 g in 1 TUBE1 tube2026-04-03NoNoCurrent