FDA.reportPublic FDA data

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 27 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest plus Tartar Protection WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company08776dfc-b07a-3729-e063-6394a90aeeed2026-01-08WarningsExact identifier
application number: M021
Crest Plus Active Fresh plus Whitening ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company17f3b749-01ea-2561-e063-6294a90a5d3b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Deep CleanSODIUM FLUORIDEProcter & Gamble Manfuacturing Company128613c4-c06b-bdf5-e063-6294a90acd342026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Pro RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company13a01190-a6f3-17b3-e063-6294a90a36c22026-01-08WarningsExact identifier
application number: M021
HEB HEBuddyFLUORIDEHEB2c972c65-34aa-4348-b997-c5e65a8845752026-01-08WarningsExact identifier
application number: M021
ARC 2 in 1 Whitening and AnticavitySODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company12634efa-35e3-76d7-e063-6294a90a3de42026-01-08Exact identifier
application number: M021
Crest Plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company15482445-39f3-7e02-e063-6294a90ad1dc2026-01-08WarningsExact identifier
application number: M021
H E B Restore and DefendFLUORIDEHEB56080493-9ab8-4b4f-be5f-7df22dee133f2026-01-08WarningsExact identifier
application number: M021
Crest Plus Cinnamon Expressions plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company151d2a0a-448f-7744-e063-6294a90acd3b2026-01-08WarningsExact identifier
application number: M021
Oral B Mouth Sore Special Care RinseHYDROGEN PEROXIDEThe Procter & Gamble Manufacturing Company22e2dc15-5794-28ed-e063-6394a90a36d32026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Anti-Cavity Max CavitySODIUM FLUORIDEThe Procter & Gamble Manufacturing Company15d70b80-3b25-bc32-e063-6394a90a163e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Bright MintSODIUM FLUORIDEProcter & Gamble Manfuacturing Company1dee0584-0fed-61c6-e063-6394a90adbcd2026-01-08WarningsExact identifier
application number: M021
HEB Gleaming White Arctic MintSODIUM FLUORIDEHEB8248eddb-20a5-7084-e053-2991aa0a16b52026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum Rescue Pro Soothing CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2f10c7ac-eb60-011e-e063-6394a90aca132026-01-08WarningsExact identifier
application number: M021
Crest Deep Cleanse Cavity DefenseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company2e09cb3b-cf59-15b1-e063-6394a90a5c6a2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Maximum Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2eaeddc5-1559-9378-e063-6394a90a4ed72026-01-08WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Dazzling MintSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company2f11e935-1711-5f1a-e063-6294a90af7d82026-01-08Exact identifier
application number: M021
HEB Gleaming White Fresh MintSODIUM FLUORIDEHEB82491c8f-d2c2-2e4a-e053-2a91aa0a572f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Pro Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company338acdf2-548c-0614-e063-6294a90af6352026-01-08Exact identifier
application number: M021
KIDS Crest Advanced Sugar and Bacteria ShieldSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2f371af0-a2d4-25a6-e063-6394a90a923d2026-01-08WarningsExact 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