FDA.reportPublic FDA data

Colgate Total SF Clean Mint

Product NDC
35000-272
11-digit product format
350000272
Labeler code
35000
Product ID
35000-272_48df3512-91fb-4b5c-a1c8-79b1c5577c75
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 Clean Mint
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
8e79e33c-88d3-afc2-e5a2-c6ad55db0dc0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-272-21Colgate Total SF Clean Mint1 in 1 CARTONPASTE, DENTIFRICE11
35000-272-21Colgate Total SF Clean Mint59 g in 1 TUBEPASTE, DENTIFRICE591
35000-272-25Colgate Total SF Clean Mint24.9 g in 1 TUBEPASTE, DENTIFRICE24.91
35000-272-25Colgate Total SF Clean Mint1 in 1 CARTONPASTE, DENTIFRICE11
35000-272-32Colgate Total SF Clean Mint93 g in 1 TUBEPASTE, DENTIFRICE931
35000-272-32Colgate Total SF Clean Mint1 in 1 CARTONPASTE, DENTIFRICE11
35000-272-47Colgate Total SF Clean Mint1 in 1 CARTONPASTE, DENTIFRICE11
35000-272-47Colgate Total SF Clean Mint144 g in 1 TUBEPASTE, DENTIFRICE1441
35000-272-60Colgate Total SF Clean Mint170 g in 1 TUBEPASTE, DENTIFRICE1701
35000-272-60Colgate Total SF Clean Mint1 in 1 CARTONPASTE, DENTIFRICE11
35000-272-65Colgate Total SF Clean Mint144 g in 1 TUBEPASTE, DENTIFRICE1441
35000-272-65Colgate Total SF Clean Mint2 in 1 CARTONPASTE, DENTIFRICE21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-272COLGATE TOTAL SF CLEAN MINT (STANNOUS FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]1Current NDC, 12 package rows20241019_8e79e33c-88d3-afc2-e5a2-c6ad55db0dc0.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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN8e79e33c-88d3-afc2-e5a2-c6ad55db0dc01
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD8e79e33c-88d3-afc2-e5a2-c6ad55db0dc01
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY8e79e33c-88d3-afc2-e5a2-c6ad55db0dc01
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY8e79e33c-88d3-afc2-e5a2-c6ad55db0dc01
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY8e79e33c-88d3-afc2-e5a2-c6ad55db0dc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-272-21350000272211 TUBE in 1 CARTON (35000-272-21) / 59 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-272-25350000272251 TUBE in 1 CARTON (35000-272-25) / 24.9 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-272-32350000272321 TUBE in 1 CARTON (35000-272-32) / 93 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-272-47350000272471 TUBE in 1 CARTON (35000-272-47) / 144 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-272-60350000272601 TUBE in 1 CARTON (35000-272-60) / 170 g in 1 TUBE1 tube2024-10-18NoNoCurrent
35000-272-65350000272652 TUBE in 1 CARTON (35000-272-65) / 144 g in 1 TUBE2 tube2024-10-18NoNoCurrent