FDA.reportPublic FDA data

Colgate Sensitive Whitening

Product NDC
35000-131
11-digit product format
350000131
Labeler code
35000
Product ID
35000-131_12dc4fbb-69dc-449f-ba17-7c2f3723e726
Type
HUMAN OTC DRUG
Nonproprietary name
POTASSIUM NITRATE and SODIUM FLUORIDE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.1 mg/g; 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 Sensitive Whitening
Listing expiration
2027-12-31

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
3b656928-af58-4ee9-8fb8-360688eb9bf3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-131-34Colgate Sensitive Whitening170 g in 1 TUBEGEL, DENTIFRICE1701
35000-131-34Colgate Sensitive Whitening2 in 1 CARTONGEL, DENTIFRICE21
35000-131-46Colgate Sensitive Whitening1 in 1 CARTONGEL, DENTIFRICE11
35000-131-46Colgate Sensitive Whitening130 g in 1 TUBEGEL, DENTIFRICE1301
35000-131-60Colgate Sensitive Whitening1 in 1 CARTONGEL, DENTIFRICE11
35000-131-60Colgate Sensitive Whitening170 g in 1 TUBEGEL, DENTIFRICE1701

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 20 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Mouth Sore ReliefBENZOCAINEWalgreens253d7ea2-e48e-c7d7-e063-6394a90ae0012025-08-12WarningsExact identifier
application number: M022
Charm Tex FLUORIDE GelSODIUM FLUORIDEYangzhou Hongshengding Chemical Co.,Ltd.897b0102-1c96-4699-908e-a7b7e26cd29f2025-08-08WarningsExact identifier
application number: M022
Meijer Enamel GuardPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer Distribution Inc82bc95be-0a07-3f00-e053-2a91aa0a74382025-08-08WarningsExact identifier
application number: M022
Topco Associates LLC Maximum StrengthFLUORIDETopco Associates LLCac398ff0-0010-4e13-8b89-dc986fd7f9742025-08-08WarningsExact identifier
application number: M022
QUALITY CHOICE SALINEPLUS SOOTHING ALOEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)4ae4e88a-aaa5-4195-bedc-622fd5cd93942025-07-30WarningsExact identifier
application number: M022
Aseptil RojoPHENOLMenper Distributors, Inc.62c96dc1-4698-43c1-8e6d-f4062dc5eea22025-07-22WarningsExact identifier
application number: M022
AnestenkaBENZOCAINEMenper Distributors, Inc00a3f1bc-ddfe-47c6-8221-f48f915135032025-07-22WarningsExact identifier
application number: M022
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
application number: M022
SprinJene Natural Sensitivity and GumPOTASSIUM NITRATEHealth and Natural Beauty USA Corp3cb23e36-0e8c-4172-b4ae-859b58a2739f2025-07-07WarningsExact identifier
application number: M022
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsExact identifier
application number: M022
Sensodyne Pronamel Kids Berry TwistSODIUM FLUORIDEHaleon US Holdings LLC69c07c36-b5e0-420b-ab29-7d10913863222025-07-03WarningsExact identifier
application number: M022
DenTek Instant Pain Relief Maximum StrengthBENZOCAINEDenTek Oral Care, Inc.ae92b76e-815a-4b4c-8128-bd045098caa52025-06-30WarningsExact identifier
application number: M022
Sensodyne Clinical White Stain ProtectorPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC99037e59-53d6-492c-8fce-67641fc8efdd2025-06-25WarningsExact identifier
application number: M022
Iolite-SBENZOCAINEDharma Research, Inc.b3b68914-2adc-4f07-9521-0b18756be5222025-06-14WarningsExact identifier
application number: M022
Red Cross ToothacheEUGENOLThe Mentholatum Company3537e599-65d9-48d6-8a46-d42312f71e842025-06-11WarningsExact identifier
application number: M022
QUALITY CHOICE Sore ThroatPHENOLCHAIN DRUG MARKETING ASSOCIATIONc95ee086-f384-475d-ad0c-75518cb9d2fe2025-06-10WarningsExact identifier
application number: M022
Onral Oral Pain Reliever MouthwashBENZOCAINESyka Pharma Inc.5dd8d933-6f32-4eaf-8eca-9365d7de55a22025-06-03WarningsExact identifier
application number: M022
Orajel Rescue Relief PenORAL PAIN RELIEVERChurch & Dwight Co., Inc.2d68eec5-ae8a-9cdf-e063-6294a90a97992025-06-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC9e1f7462-a052-4db4-bc59-cce437b695d02025-05-20WarningsExact identifier
application number: M022
Saline 1.5 FL OZSALINEALAINA HEALTHCARE PRIVATE LIMITEDf1bdbb25-6943-4828-9ae0-7d9783c18b5f2025-05-19WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN3b656928-af58-4ee9-8fb8-360688eb9bf31
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD3b656928-af58-4ee9-8fb8-360688eb9bf31
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY3b656928-af58-4ee9-8fb8-360688eb9bf31
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY3b656928-af58-4ee9-8fb8-360688eb9bf31
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3b656928-af58-4ee9-8fb8-360688eb9bf31
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3b656928-af58-4ee9-8fb8-360688eb9bf31
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY3b656928-af58-4ee9-8fb8-360688eb9bf31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-131-34350000131342 TUBE in 1 CARTON (35000-131-34) / 170 g in 1 TUBE2 tube2026-01-01NoNoCurrent
35000-131-46350000131461 TUBE in 1 CARTON (35000-131-46) / 130 g in 1 TUBE1 tube2026-01-01NoNoCurrent
35000-131-60350000131601 TUBE in 1 CARTON (35000-131-60) / 170 g in 1 TUBE1 tube2026-01-01NoNoCurrent