FDA.reportPublic FDA data

Colgate Sensitive plus Whitening

Product NDC
35000-023
11-digit product format
350000023
Labeler code
35000
Product ID
35000-023_a0bc4e50-643e-47cb-a47f-b3978c197387
Type
HUMAN OTC DRUG
Nonproprietary name
POTASSIUM NITRATE and SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-25
Marketing end
2027-12-31
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.1 mg/g; mg/g
NDC exclude flag
No
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 Sensitive plus Whitening

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038929Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2092c747-e025-47a9-9e54-731631d3c831Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-023-34Colgate Sensitive plus Whitening2 in 1 CARTONPASTE, DENTIFRICE28
35000-023-34Colgate Sensitive plus Whitening170 g in 1 TUBEPASTE, DENTIFRICE1708
35000-023-46Colgate Sensitive plus Whitening130 g in 1 TUBEPASTE, DENTIFRICE1308
35000-023-46Colgate Sensitive plus Whitening1 in 1 CARTONPASTE, DENTIFRICE18
35000-023-60Colgate Sensitive plus Whitening1 in 1 CARTONPASTE, DENTIFRICE18
35000-023-60Colgate Sensitive plus Whitening170 g in 1 TUBEPASTE, DENTIFRICE1708

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-023COLGATE SENSITIVE PLUS WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]7Current NDC, Legacy NDC, 6 package rows20240113_2092c747-e025-47a9-9e54-731631d3c831.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 38 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc80182c43-100f-4b15-a07e-819599ab95622023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc19e6426-8f1e-47b3-a3a6-551a5bec6cd92023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1f8431bb-f33c-4fd8-9472-9b59ffb5f18e2023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc1163d248-d648-443e-bed0-ccb7fd26ba632023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc88caabe2-a096-44d0-98d3-afad1935c0122023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Incc1b02a2f-db1f-44f0-a74a-d02c085c5bd72023-12-07WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc39081585-fe6a-4ba1-93f8-d92d26fe75bc2023-12-07WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d7c69357-795c-03d8-e053-2a95a90a03a62023-12-06WarningsExact identifier
application number: M022
Dr. Sheffield Sensitive CareSENSITIVE TOOTH PASTESheffield Pharmaceuticals LLC702a0dec-64cf-4834-8d80-f3d4f0c08a3a2023-11-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCf3bf106c-5320-ced2-e053-2a95a90a71ac2023-11-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b517321-25ed-2676-e063-6294a90ab4c92023-11-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0b51b67c-03ac-5730-e063-6394a90a50602023-11-29WarningsExact identifier
application number: M022
Pearl WhitePOTASSIUM NITRATE, SODIUM FLUORIDEBeyond International Inc.51c79544-9536-5863-e054-00144ff8d46c2023-11-28WarningsExact identifier
application number: M022
UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE AND SODIUM FLUORIDEUniversal Distribution Center LLCfcf59439-7e06-4129-a89f-cdeecdf8d4882023-11-17WarningsExact identifier
application number: M022
PerioRestoreHYDROGEN PEROXIDEDEN-MAT HOLDINGS, LLC.97a07c36-1af8-a636-e053-2a95a90ad6db2023-11-13WarningsExact identifier
application number: M022
Wild Horse 777 OralPHENOLWild Horse 777, Inc.b0b517bb-969f-0c65-e053-2995a90a48b12023-11-10WarningsExact identifier
application number: M022
ORCA Pain Reliever Putty with MentholMENTHOLORCA Products, LLC188cb01a-3d0f-43d9-983e-6475c0c5b06e2023-11-10WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC33fbdbc7-e10d-4181-926f-9b591b5b07e32023-11-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0d2c8c0c-4c72-4400-b3b5-ed578fa351672023-11-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEDegasa, S.A. de C.V.45ac0275-4c68-3897-e054-00144ff8d46c2023-11-05WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN2092c747-e025-47a9-9e54-731631d3c8318
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD2092c747-e025-47a9-9e54-731631d3c8318
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2092c747-e025-47a9-9e54-731631d3c8318
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY2092c747-e025-47a9-9e54-731631d3c8318
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2092c747-e025-47a9-9e54-731631d3c8318
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2092c747-e025-47a9-9e54-731631d3c8318
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY2092c747-e025-47a9-9e54-731631d3c8318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-023-34350000023342 TUBE in 1 CARTON (35000-023-34) / 170 g in 1 TUBE2 tube2019-02-252027-12-31NoNoCurrent
35000-023-46350000023461 TUBE in 1 CARTON (35000-023-46) / 130 g in 1 TUBE1 tube2020-06-152027-12-31NoNoCurrent
35000-023-60350000023601 TUBE in 1 CARTON (35000-023-60) / 170 g in 1 TUBE1 tube2019-02-252027-12-31NoNoCurrent