FDA.reportPublic FDA data

COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINT

Product NDC
35000-917
11-digit product format
350000917
Labeler code
35000
Product ID
35000-917_52af82ce-d7aa-4279-b8c7-877e4b59e090
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-11-16
Substance
SODIUM 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 ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9aaa451d-8827-41b7-9661-bc1a7a69cfc3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-917-60COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINT1 in 1 CARTONPASTE, DENTIFRICE16
35000-917-60COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINT170 g in 1 TUBEPASTE, DENTIFRICE1706
35000-917-71COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINT1 in 1 CARTONPASTE, DENTIFRICE16
35000-917-71COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINT119 g in 1 TUBEPASTE, DENTIFRICE1196

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-917COLGATE ULTRA BRITE ADVANCED WHITENING ALL IN ONE CLEAN MINT (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]2Current NDC, Legacy NDC, 4 package rows20241020_9aaa451d-8827-41b7-9661-bc1a7a69cfc3.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 14 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnticavitySODIUM FLUORIDEOld East Main Co.64f3d92d-f58c-4bc2-8819-f91492221ddb2026-03-02Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.c7b9e9cd-3cf7-4657-83c9-e221e1c359772026-03-02Warnings, Adverse reactionsExact identifier
application number: M021
Instant WhiteningINSTANT WHITENING TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd2807ece8-a1a5-b626-e063-6394a90aac622026-03-02WarningsExact identifier
application number: M021
Coffe Tea Stain Remover ToothCOFFE TEA STAIN REMOVER TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd2845d7af-7a0b-9bc8-e063-6294a90ac8b32026-03-02WarningsExact identifier
application number: M021
Professional whitening toothPROFESSIONAL WHITENING TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd291eba71-14da-fac3-e063-6294a90aa3cc2026-03-02WarningsExact identifier
application number: M021
purple toothPURPLE TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd291f0312-238c-71d5-e063-6294a90a39e12026-03-02WarningsExact identifier
application number: M021
Professional ChoicePROFESSIONAL CHOICE TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd28406739-6a8c-1ce8-e063-6394a90a08f82026-03-02WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.27a98b64-8369-4f3d-b487-d7ce98abc69f2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.390dd1b5-2dd1-4b55-b4b3-e441ada612382026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEThe Kroger Co.5459eeee-adf0-4afe-b190-62d4fa1138062026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEThe Kroger Co.932723b8-9875-4f37-8c11-018c94ae0ae12026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.d0c552d8-44ad-4d95-b3fb-17015f44b3342026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEWalmart Inc.3beb65e4-ae8e-4e51-b9ba-181cbec41eff2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.61669087-0af6-4192-b514-afcfe7d8ba982026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEWalmart Inc.1fd2f3ca-066e-282a-e063-6294a90a05a92026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.af5b93e7-5cce-4e01-8df2-54494d8b29102026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.4590ca97-130c-46b2-9ba0-38f4703ef30a2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD.4ba81636-cdb7-e904-e063-6394a90a8bd52026-02-25WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEFamily Dollar Stores, Inc32a92add-c9db-4733-8e35-613825fdf0812026-02-24Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN9aaa451d-8827-41b7-9661-bc1a7a69cfc36
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD9aaa451d-8827-41b7-9661-bc1a7a69cfc36
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY9aaa451d-8827-41b7-9661-bc1a7a69cfc36
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY9aaa451d-8827-41b7-9661-bc1a7a69cfc36
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY9aaa451d-8827-41b7-9661-bc1a7a69cfc36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-917-60350000917601 TUBE in 1 CARTON (35000-917-60) / 170 g in 1 TUBE1 tube2005-11-160000-00-00NoNoCurrent
35000-917-71350000917711 TUBE in 1 CARTON (35000-917-71) / 119 g in 1 TUBE1 tube2026-03-01NoNoCurrent