FDA.reportPublic FDA data

COLGATE

Product NDC
35000-959
Requested package NDC
35000-959-64
11-digit product format
350000959
Labeler code
35000
Product ID
35000-959_de36f93f-e70b-4135-ac3c-34557d22bf46
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-20
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-95935000-959-64DDiscontinued by firm2026-08-10

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
COLGATE
Brand name suffix
Baking Soda and Peroxide Whitening Brisk Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
913a2cd6-b6a8-4069-979f-3c696a9bfdf0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-959-10COLGATEBaking Soda and Peroxide Whitening Brisk Mint164 g in 1 TUBEPASTE, DENTIFRICE16410
35000-959-10COLGATEBaking Soda and Peroxide Whitening Brisk Mint1 in 1 CARTONPASTE, DENTIFRICE110
35000-959-35COLGATEBaking Soda and Peroxide Whitening Brisk Mint170 g in 1 TUBEPASTE, DENTIFRICE17010
35000-959-35COLGATEBaking Soda and Peroxide Whitening Brisk Mint3 in 1 CARTONPASTE, DENTIFRICE310
35000-959-46COLGATEBaking Soda and Peroxide Whitening Brisk Mint130 g in 1 TUBEPASTE, DENTIFRICE13010
35000-959-46COLGATEBaking Soda and Peroxide Whitening Brisk Mint1 in 1 CARTONPASTE, DENTIFRICE110
35000-959-48COLGATEBaking Soda and Peroxide Whitening Brisk Mint1 in 1 CARTONPASTE, DENTIFRICE110
35000-959-48COLGATEBaking Soda and Peroxide Whitening Brisk Mint226 g in 1 TUBEPASTE, DENTIFRICE22610
35000-959-57COLGATEBaking Soda and Peroxide Whitening Brisk Mint170 g in 1 TUBEPASTE, DENTIFRICE17010
35000-959-57COLGATEBaking Soda and Peroxide Whitening Brisk Mint2 in 1 CARTONPASTE, DENTIFRICE210
35000-959-58COLGATEBaking Soda and Peroxide Whitening Brisk Mint1 in 1 CARTONPASTE, DENTIFRICE110
35000-959-58COLGATEBaking Soda and Peroxide Whitening Brisk Mint70 g in 1 TUBEPASTE, DENTIFRICE7010
35000-959-59COLGATEBaking Soda and Peroxide Whitening Brisk Mint107 g in 1 TUBEPASTE, DENTIFRICE10710
35000-959-59COLGATEBaking Soda and Peroxide Whitening Brisk Mint1 in 1 CARTONPASTE, DENTIFRICE110
35000-959-60COLGATEBaking Soda and Peroxide Whitening Brisk Mint170 g in 1 TUBEPASTE, DENTIFRICE17010
35000-959-60COLGATEBaking Soda and Peroxide Whitening Brisk Mint1 in 1 CARTONPASTE, DENTIFRICE110
35000-959-64COLGATEBaking Soda and Peroxide Whitening Brisk Mint181 g in 1 TUBEPASTE, DENTIFRICE18110
35000-959-64COLGATEBaking Soda and Peroxide Whitening Brisk Mint1 in 1 CARTONPASTE, DENTIFRICE110
35000-959-69COLGATEBaking Soda and Peroxide Whitening Brisk Mint113 g in 1 TUBEPASTE, DENTIFRICE11310
35000-959-69COLGATEBaking Soda and Peroxide Whitening Brisk Mint1 in 1 CARTONPASTE, DENTIFRICE110
35000-959-75COLGATEBaking Soda and Peroxide Whitening Brisk Mint1 in 1 CARTONPASTE, DENTIFRICE110
35000-959-75COLGATEBaking Soda and Peroxide Whitening Brisk Mint79 g in 1 TUBEPASTE, DENTIFRICE7910
35000-959-82COLGATEBaking Soda and Peroxide Whitening Brisk Mint232 g in 1 TUBEPASTE, DENTIFRICE23210
35000-959-82COLGATEBaking Soda and Peroxide Whitening Brisk Mint1 in 1 CARTONPASTE, DENTIFRICE110
35000-959-92COLGATEBaking Soda and Peroxide Whitening Brisk Mint1 in 1 CARTONPASTE, DENTIFRICE110
35000-959-92COLGATEBaking Soda and Peroxide Whitening Brisk Mint141 g in 1 TUBEPASTE, DENTIFRICE14110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-959COLGATE BAKING SODA AND PEROXIDE WHITENING BRISK MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE PALMOLIVE COMPANY]7Current NDC, Legacy NDC, 26 package rows20241127_913a2cd6-b6a8-4069-979f-3c696a9bfdf0.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 1 of 52 · 1,027 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
Colgate Optic White Stain Fighter With Baking SodaSODIUM FLUORIDEColgate-Palmolive Company8e6113e2-101b-4bde-90e9-6ab32c6ebf5c2026-08-05WarningsExact identifier
application number: M021
TOTAL TP CLEAN MINT PSTSTANNOUS FLUORIDEColgate-Palmolive Company178d4535-fa57-4b53-b1f8-5c591f2ea9e72026-08-05WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PRO SERIESSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd954777-697a-4cc7-8f5f-b2caf357ef952026-08-05WarningsExact identifier
application number: M021
COLGATE MAX FRESH WATERMELON BLASTSODIUM FLUORIDEColgate-Palmolive Company6c391ef3-d625-403c-a4dc-6e2212682ed12026-08-04WarningsExact identifier
application number: M021
COLGATE 2 IN 1 KIDS SP STRAWBERRYSODIUM FLUORIDEColgate-Palmolive Companyd037f65c-3d22-4d2a-a0a9-3dcba2357ebd2026-08-04WarningsExact identifier
application number: M021
Colgate ULTRA BRITE Baking Soda and Peroxide WhiteningSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company2b123d70-4f7d-41b0-b48f-711999e97ee02026-08-04WarningsExact identifier
application number: M021
Rorobell WaWa ToothSODIUM MONOFLUOROPHOSPHATEROROBELL93113481-ad9d-4be0-a7b7-a72c8726127d2026-08-03WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE CHARCOALSODIUM FLUORIDEColgate-Palmolive Company70ed4a93-b68f-4198-b4b7-7cfeb17ba5d22026-07-30WarningsExact identifier
application number: M021
Colgate Optic White CharcoalSODIUM FLUORIDEColgate-Palmolive Company82ac5b9d-19e8-46ac-a195-c7d85f2967d52026-07-30WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc251264ea-20d2-be19-e063-6394a90aa5f62026-07-29WarningsExact identifier
application number: M021
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
application number: M021
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company76df52a3-b24c-4009-8137-fe644dabebf62026-07-29WarningsExact identifier
application number: M021
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Vividly FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf0551acf-c4d6-4d49-ae9c-4aeaeb99a7002026-07-29WarningsExact identifier
application number: M021
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN913a2cd6-b6a8-4069-979f-3c696a9bfdf010
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD913a2cd6-b6a8-4069-979f-3c696a9bfdf010
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY913a2cd6-b6a8-4069-979f-3c696a9bfdf010
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY913a2cd6-b6a8-4069-979f-3c696a9bfdf010
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY913a2cd6-b6a8-4069-979f-3c696a9bfdf010
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY913a2cd6-b6a8-4069-979f-3c696a9bfdf010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-959-64350000959641 TUBE in 1 CARTON (35000-959-64) > 181 g in 1 TUBE1 tube2011-08-200000-00-00NoNoCurrent