Colgate Total Whitening Charcoal

Product NDC
35000-571
11-digit product format
350000571
Labeler code
35000
Product ID
35000-571_a95051eb-ef65-4886-b899-5fae8e271aaf
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
2020-12-10
Marketing end
2026-12-31
Substance
STANNOUS FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-57135000-571-48DDiscontinued by firm2026-10-15
excluded packagepackage35000-57135000-571-96DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0535000-571-96d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0535000-571-48d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2635000-571-96f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2635000-571-48f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3135000-571-962ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3135000-571-482ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2835000-571-96a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2835000-571-48a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2135000-571-96cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2135000-571-48cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1035000-571-96cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1035000-571-48cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3135000-571-96302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3135000-571-48302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2035000-571-96ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2035000-571-48ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1035000-571-960efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1035000-571-480efc9e666f02…f202fb6c5f17…

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 Whitening Charcoal

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
56434e3d-ba0a-8b42-6c97-0d0055606793Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-571-32Colgate Total Whitening Charcoal1 in 1 CARTONPASTE, DENTIFRICE110
35000-571-32Colgate Total Whitening Charcoal93 g in 1 TUBEPASTE, DENTIFRICE9310
35000-571-48Colgate Total Whitening Charcoal136 g in 1 TUBEPASTE, DENTIFRICE13610
35000-571-48Colgate Total Whitening Charcoal1 in 1 CARTONPASTE, DENTIFRICE110
35000-571-65Colgate Total Whitening Charcoal144 g in 1 TUBEPASTE, DENTIFRICE14410
35000-571-65Colgate Total Whitening Charcoal2 in 1 CARTONPASTE, DENTIFRICE210
35000-571-66Colgate Total Whitening Charcoal144 g in 1 TUBEPASTE, DENTIFRICE14410
35000-571-66Colgate Total Whitening Charcoal1 in 1 CARTONPASTE, DENTIFRICE110
35000-571-96Colgate Total Whitening Charcoal136 g in 1 TUBEPASTE, DENTIFRICE13610
35000-571-96Colgate Total Whitening Charcoal2 in 1 CARTONPASTE, DENTIFRICE210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-571COLGATE TOTAL WHITENING CHARCOAL (STANNOUS FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]10Current NDC, Legacy NDC, 10 package rows20241003_56434e3d-ba0a-8b42-6c97-0d0055606793.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 13 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.ed617c7a-805c-4788-9bce-9b7fead4312d2026-03-31WarningsExact identifier
application number: M021
Colgate Total Enamel StrengthSTANNOUS FLUORIDEColgate-Palmolive Company1f29c893-e7c5-4a0e-941b-c2634d8211472026-03-25WarningsExact identifier
application number: M021
AP-24 WhiteningSODIUM MONOFLUOROPHOSPHATENSE Products, Inc.57e9e68c-41dd-470b-80db-dfaedc0e2a0a2026-03-24WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369c0d44-6375-dcae-e063-6394a90a74d02026-03-24WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369bc785-fb77-a56d-e063-6394a90a2e6b2026-03-24WarningsExact identifier
application number: M021
SensitiveToothpasteANTI SENSITIVETOOTHPASTEHuain Best Trade Co., Ltd.4db239f3-2ad7-3a5b-e063-6294a90a11a72026-03-23WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d6268c7-b273-1bbf-e053-2a91aa0a5d322026-03-17WarningsExact identifier
application number: M021
Natures Promise Childrens Fluoride StrawberrySODIUM MONOFLUOROPHOSPHATEFoodhold U.S.A.81a4e196-8b2d-0745-e053-2991aa0a7de62026-03-16WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae8badf-f960-62fd-e054-00144ff8d46c2026-03-11WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae71258-a8c2-6eb5-e054-00144ff88e882026-03-11WarningsExact identifier
application number: M021
Delta Travel Kit Comfort plusSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.d31e0920-4317-1e0c-e053-2a95a90aebeb2026-03-11WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.eac346d9-d9c1-4417-8193-390c7a0dcc2a2026-03-10Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6caf3f2e-70a2-4530-99fa-f5af7e4c511a2026-03-10WarningsExact identifier
application number: M021
Amerfresh ToothpowderSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD1cacf93e-aa60-4717-87ab-0568a701a4f32026-03-10WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.a51357df-6d55-4030-a5db-42da7ba54a372026-03-09Warnings, Adverse reactionsExact identifier
application number: M021
FluorideFLUORIDE TOOTHPASTEMcKesson4c482e45-0502-a93a-e063-6394a90aa9612026-03-05WarningsExact identifier
application number: M021
Colgate Maximum Cavity Protection Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company0a1389f6-cac9-3d58-0744-c488abb0bbcc2026-03-03WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEAmazon.com Services LLC349eca80-2e0c-409b-af29-3235fdc0695b2026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEAmazon.com Services LLC03735abc-d1be-4ca0-a497-0a5c5f2894022026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.f8036e2e-7541-4922-92b9-0d8319f7b64c2026-03-02Warnings, 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 % ) ToothpastePSN56434e3d-ba0a-8b42-6c97-0d005560679310
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD56434e3d-ba0a-8b42-6c97-0d005560679310
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY56434e3d-ba0a-8b42-6c97-0d005560679310
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY56434e3d-ba0a-8b42-6c97-0d005560679310
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY56434e3d-ba0a-8b42-6c97-0d005560679310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-571-32350000571321 TUBE in 1 CARTON (35000-571-32) / 93 g in 1 TUBE1 tube2021-01-202026-12-31NoNoCurrent
35000-571-48350000571481 TUBE in 1 CARTON (35000-571-48) > 136 g in 1 TUBE1 tube2020-12-100000-00-00NoNoCurrent
35000-571-65350000571652 TUBE in 1 CARTON (35000-571-65) / 144 g in 1 TUBE2 tube2021-12-082026-12-31NoNoCurrent
35000-571-66350000571661 TUBE in 1 CARTON (35000-571-66) / 144 g in 1 TUBE1 tube2021-12-272026-12-31NoNoCurrent
35000-571-96350000571962 TUBE in 1 CARTON (35000-571-96) > 136 g in 1 TUBE2 tube2020-12-110000-00-00NoNoCurrent