Colgate Total SF Whitening

Product NDC
35000-274
11-digit product format
350000274
Labeler code
35000
Product ID
35000-274_78273a66-b594-45cd-9bb6-ef1635ba153a
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
2024-10-18
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 SF Whitening
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
7f6b6aa8-50da-151b-c448-9e427d37398fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-274-14Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE11
35000-274-14Colgate Total SF Whitening39.6 g in 1 TUBEPASTE, DENTIFRICE39.61
35000-274-21Colgate Total SF Whitening59 g in 1 TUBEPASTE, DENTIFRICE591
35000-274-21Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE11
35000-274-25Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE11
35000-274-25Colgate Total SF Whitening24.9 g in 1 TUBEPASTE, DENTIFRICE24.91
35000-274-32Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE11
35000-274-32Colgate Total SF Whitening93 g in 1 TUBEPASTE, DENTIFRICE931
35000-274-47Colgate Total SF Whitening144 g in 1 TUBEPASTE, DENTIFRICE1441
35000-274-47Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE11
35000-274-60Colgate Total SF Whitening1 in 1 CARTONPASTE, DENTIFRICE11
35000-274-60Colgate Total SF Whitening170 g in 1 TUBEPASTE, DENTIFRICE1701
35000-274-65Colgate Total SF Whitening2 in 1 CARTONPASTE, DENTIFRICE21
35000-274-65Colgate Total SF Whitening144 g in 1 TUBEPASTE, DENTIFRICE1441

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-274COLGATE TOTAL SF WHITENING (STANNOUS FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]1Current NDC, 14 package rows20241019_7f6b6aa8-50da-151b-c448-9e427d37398f.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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN7f6b6aa8-50da-151b-c448-9e427d37398f1
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD7f6b6aa8-50da-151b-c448-9e427d37398f1
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY7f6b6aa8-50da-151b-c448-9e427d37398f1
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY7f6b6aa8-50da-151b-c448-9e427d37398f1
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY7f6b6aa8-50da-151b-c448-9e427d37398f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-274-14350000274141 TUBE in 1 CARTON (35000-274-14) / 39.6 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-274-21350000274211 TUBE in 1 CARTON (35000-274-21) / 59 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-274-25350000274251 TUBE in 1 CARTON (35000-274-25) / 24.9 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-274-32350000274321 TUBE in 1 CARTON (35000-274-32) / 93 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-274-47350000274471 TUBE in 1 CARTON (35000-274-47) / 144 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-274-60350000274601 TUBE in 1 CARTON (35000-274-60) / 170 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-274-65350000274652 TUBE in 1 CARTON (35000-274-65) / 144 g in 1 TUBE2 tube2024-10-18NoNoCurrent