FDA.reportPublic FDA data

Colgate Sensitive Complete Protection

Product NDC
35000-132
11-digit product format
350000132
Labeler code
35000
Product ID
35000-132_8554afd0-1aff-4b1f-8fc8-49b0b9aad95e
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
2018-11-13
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 Complete Protection
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
866067b9-3dce-492d-ae99-1b807ecd56ffAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-132-21Colgate Sensitive Complete Protection59 g in 1 TUBEPASTE, DENTIFRICE591
35000-132-21Colgate Sensitive Complete Protection1 in 1 CARTONPASTE, DENTIFRICE11
35000-132-34Colgate Sensitive Complete Protection170 g in 1 TUBEPASTE, DENTIFRICE1701
35000-132-34Colgate Sensitive Complete Protection2 in 1 CARTONPASTE, DENTIFRICE21
35000-132-60Colgate Sensitive Complete Protection1 in 1 CARTONPASTE, DENTIFRICE11
35000-132-60Colgate Sensitive Complete Protection170 g in 1 TUBEPASTE, DENTIFRICE1701
35000-132-78Colgate Sensitive Complete Protection1 in 1 CARTONPASTE, DENTIFRICE11
35000-132-78Colgate Sensitive Complete Protection22 g in 1 TUBEPASTE, DENTIFRICE221

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 39 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oral Pain ReliefBENZOCAINEGERI-CARE PHARMACEUTICAL CORPd294a39e-55f4-272d-e053-2995a90ab7f72023-10-31WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.e10c45e6-d37f-4650-b3e5-07719cc0ea492023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.886d949b-8db1-499c-a277-174f8bc29f342023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.fc8194af-2e77-4ad1-ae75-461dce3ed6042023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.baf7d184-07ed-4491-a1fc-9a377b4b01102023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.033034af-c86c-4dbf-90eb-009c117024c62023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.658ada18-2334-4b4e-b08e-702fa127aa142023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.cad932e5-8d7f-4f20-b1c2-febd328152f02023-10-11WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.2c9519ab-320d-49da-9deb-97a6168fb0882023-10-10WarningsExact identifier
application number: M022
IolineBENZOCAINEDharma Research, Inc.b862c974-c024-42c3-986e-b65069437c7b2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.651ea978-081d-4c59-b177-6049a69d94152023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.db763237-2910-45b9-be72-da092edc951b2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.34316f93-10b4-41cc-8654-625283f0044c2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.142a8824-657e-492a-8e5a-b15eb73383c92023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.414cbec9-94e2-4bca-908b-1e79f8db0b272023-10-10WarningsExact identifier
application number: M022
Sore throat cherryPHENOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)de634cf1-ed39-4d8a-8855-006c69b7aee92023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN866067b9-3dce-492d-ae99-1b807ecd56ff1
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD866067b9-3dce-492d-ae99-1b807ecd56ff1
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY866067b9-3dce-492d-ae99-1b807ecd56ff1
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY866067b9-3dce-492d-ae99-1b807ecd56ff1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY866067b9-3dce-492d-ae99-1b807ecd56ff1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY866067b9-3dce-492d-ae99-1b807ecd56ff1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY866067b9-3dce-492d-ae99-1b807ecd56ff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-132-21350000132211 TUBE in 1 CARTON (35000-132-21) / 59 g in 1 TUBE1 tube2026-01-18NoNoCurrent
35000-132-34350000132342 TUBE in 1 CARTON (35000-132-34) / 170 g in 1 TUBE2 tube2026-01-18NoNoCurrent
35000-132-60350000132601 TUBE in 1 CARTON (35000-132-60) / 170 g in 1 TUBE1 tube2026-01-18NoNoCurrent
35000-132-78350000132781 TUBE in 1 CARTON (35000-132-78) / 22 g in 1 TUBE1 tube2026-01-18NoNoCurrent