COLGATE

Product NDC
35000-959
Requested package NDC
35000-959-46
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 packagepackage35000-95935000-959-46DDiscontinued by firm2026-09-14

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 · 1,033 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZONSENToothpasteTOOTHPASTEWuhan Zonsen Medical Products Co., Ltd.5613faef-3469-569a-e063-6394a90ac32d2026-09-10WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
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
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact 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
35000-959-46350000959461 TUBE in 1 CARTON (35000-959-46) > 130 g in 1 TUBE1 tube2011-08-200000-00-00NoNoCurrent