FDA.reportPublic FDA data

Colgate Total SF Fresh Mint Stripe

Product NDC
35000-273
11-digit product format
350000273
Labeler code
35000
Product ID
35000-273_c5ef7f9f-a552-4762-8d93-d46aa695981d
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 Fresh Mint Stripe
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
657020c7-e85c-4c61-9f62-b50351e4b4e5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-273-32Colgate Total SF Fresh Mint Stripe93 g in 1 TUBEPASTE, DENTIFRICE931
35000-273-32Colgate Total SF Fresh Mint Stripe1 in 1 CARTONPASTE, DENTIFRICE11
35000-273-47Colgate Total SF Fresh Mint Stripe1 in 1 CARTONPASTE, DENTIFRICE11
35000-273-47Colgate Total SF Fresh Mint Stripe144 g in 1 TUBEPASTE, DENTIFRICE1441
35000-273-65Colgate Total SF Fresh Mint Stripe144 g in 1 TUBEPASTE, DENTIFRICE1441
35000-273-65Colgate Total SF Fresh Mint Stripe2 in 1 CARTONPASTE, DENTIFRICE21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-273COLGATE TOTAL SF FRESH MINT STRIPE (STANNOUS FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]1Current NDC, 6 package rows20241019_657020c7-e85c-4c61-9f62-b50351e4b4e5.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 17 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Complete plus Whitening plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company960e0e3e-10e8-7426-e053-2a95a90a5b022026-02-12WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8693fa6d-e9c9-4cb7-bd3d-8ad87a7bb77e2026-02-12WarningsExact identifier
application number: M021
Kids Crest Cavity Protection Sparkle FunSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company126c6f39-0ef7-40ee-b3ba-e56a76739c572026-02-12WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.b2f7490c-e2af-49df-b054-70fb4815f7292026-02-11Warnings, Adverse reactionsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITEDb7d7c41e-f8b6-4e55-8acd-78eb6dda47c52026-02-09WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED48ef2635-7157-4cd7-9f99-967f0143f7f12026-02-09WarningsExact identifier
application number: M021
Made by Dentists For Kids Eyeball Juice (Watermelon)SODIUM FLUORIDEMADE BY DENTISTS INC287887df-64de-4b5d-80e2-146c77c0fa8b2026-02-09WarningsExact identifier
application number: M021
PERIOSCIENCES White Care AO ProSODIUM FLUORIDEPERIOSCIENCES LLC092bdfa3-6267-439e-9320-e51b4805d1a12026-02-09WarningsExact identifier
application number: M021
PERIOSCIENCES HYDRATING AO ProSODIUM MONOFLUOROPHOSPHATEPERIOSCIENCES LLC5e380ca7-3d8e-4d51-a6ff-63c5a6bfe0d32026-02-09WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDERetail Business Services, LLC77c066cf-f064-45d3-9732-4433165ba9ef2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDERetail Business Services, LLCd1c878a9-2151-4986-be09-cbab658cdd312026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDERetail Business Services, LLC542e067a-c134-44c9-b962-f2a2b667b76f2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
Colgate 5g Toothbrush KitSODIUM MONOFLUOROPHOSPHATEWuhan Jinshengyuan Textiles Manufacturing Co., Ltd.4f0fda5e-ef42-42c3-8270-3ba614650ad12026-02-06WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDERetail Business Services, LLC3954edfd-f7f1-4218-9ee2-23f5b3661b4e2026-02-06Warnings, Adverse reactionsExact identifier
application number: M021
TheraBreath Kids Anticavity Oral Rinse BubblegumANTICAVITY ORAL RINSEChurch & Dwight Co., Inc.2770424d-7416-66d4-e063-6394a90ad4b12026-02-06WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity Whitening Plus ScopeSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company463b7820-a5ce-f8b5-e063-6394a90aa0182026-02-05WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEPublix Super Markets, Inc.14494238-872b-49e2-8bf7-df3844a0a6c82026-02-05Warnings, Adverse reactionsExact identifier
application number: M021
HAPEE EXPLOSIVE MENTHOL RED 150SODIUM MONOFLUOROPHOSPHATELAMOIYAN CORPORATION14c14694-6149-40a8-aff2-660d39f7e0c12026-02-05WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEHARRIS TEETERf759e9e4-6de2-4b80-903b-e67c06e362952026-02-04Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEHARRIS TEETER571f7628-fd59-462f-96dd-67aeaa98cff12026-02-04Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN657020c7-e85c-4c61-9f62-b50351e4b4e51
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD657020c7-e85c-4c61-9f62-b50351e4b4e51
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY657020c7-e85c-4c61-9f62-b50351e4b4e51
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY657020c7-e85c-4c61-9f62-b50351e4b4e51
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY657020c7-e85c-4c61-9f62-b50351e4b4e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-273-32350000273321 TUBE in 1 CARTON (35000-273-32) / 93 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-273-47350000273471 TUBE in 1 CARTON (35000-273-47) / 144 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-273-65350000273652 TUBE in 1 CARTON (35000-273-65) / 144 g in 1 TUBE2 tube2024-10-18NoNoCurrent