Colgate Sensitive Enamel Health

Product NDC
35000-130
11-digit product format
350000130
Labeler code
35000
Product ID
35000-130_cd41d876-bc09-44f4-a530-f32f2be25318
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
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 Enamel Health
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
a50d4259-8a79-417e-b381-72c7a8ec0418Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-130-60Colgate Sensitive Enamel Health1 in 1 CARTONPASTE, DENTIFRICE11
35000-130-60Colgate Sensitive Enamel Health170 g in 1 TUBEPASTE, 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 32 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORGANIC PEPPERMINT HERB THROAT DROPSMENTHOLRicola USA Inc.f75c8967-40e6-473a-b403-941354cb0be12024-12-10WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola USA Inc.c56be34d-1dd5-4200-9723-3a73180cb7592024-12-10WarningsExact identifier
application number: M022
Cherry Throat DropsMENTHOLRicola USA Inc.89257ceb-af0f-4516-88f7-6dfdab9e14f42024-12-10WarningsExact identifier
application number: M022
BERRY MEDLEY THROAT DROPSMENTHOLRicola USA Inc.9bfd2ea7-745b-47f8-bd8a-9dbeeaad8b952024-12-10WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola USA Inc.6a81e5c7-834d-44da-853f-8f61032363112024-12-10WarningsExact identifier
application number: M022
SUGAR FREE SWISS CHERRY HERB THROAT DROPSMENTHOLRicola USA Inc.8a24f614-8e21-4ab2-8c0e-6af947911ccd2024-12-10WarningsExact identifier
application number: M022
RICOLA MAX NASAL CARE COOL MENTHOLMENTHOLRicola USA Inc.a2e189a2-65ae-48a9-99ad-8795334082df2024-12-10WarningsExact identifier
application number: M022
COOL RELIEF LEMON FROST ORAL ANESTHETICMENTHOLRicola USA Inc.40c3a80a-a116-4607-bb4a-c89d255ee0762024-12-10WarningsExact identifier
application number: M022
COOL RELIEF ORAL ANESTHETICMENTHOLRicola USA Inc.d66f47a9-35ab-4bf9-8065-c81abcb503f52024-12-10WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola USA Inc.62a631d3-e6d0-4fca-ad0c-7c1b67d2a8272024-12-10WarningsExact identifier
application number: M022
COOL RELIEF ORAL ANESTHETICMENTHOLRicola USA Inc.3f93919f-e63e-470d-9d9a-f6ea3492c23d2024-12-10WarningsExact identifier
application number: M022
Throat Balm Caramel PectinPECTINRicola USA Inc.23cf2ba5-9d4d-409b-ab0e-a1d702f0bb152024-12-10WarningsExact identifier
application number: M022
Cherry Throat DropsMENTHOLRicola USA Inc.4cbf9094-6b50-4bef-bb36-2df6cb868ac72024-12-10WarningsExact identifier
application number: M022
SUCRETS VAPOR CHERRYDYCLONINE HYDROCHLORIDE AND MENTHOLInsight Pharmaceuticals LLC471af502-5b3a-4897-b22d-78859b73a2172024-12-05WarningsExact identifier
application number: M022
Cherry Throat DropsMENTHOLRicola Agbb236392-1f7c-4cb5-ae9a-9cb1c60d133e2024-12-05WarningsExact identifier
application number: M022
RICOLA MAX NASAL CARE COOL MENTHOLMENTHOLRicola Agdfecd10f-adbe-4be7-854d-f9f202fef1452024-12-05WarningsExact identifier
application number: M022
COOL RELIEF ORAL ANESTHETICMENTHOLRicola Ag3698a69f-b5c0-4235-8ef8-71c867f1ac0d2024-12-05WarningsExact identifier
application number: M022
Throat Balm Caramel PectinPECTINRicola Agedbd7a73-8f06-4a1e-a459-3d7a4355fc9b2024-12-05WarningsExact identifier
application number: M022
SUGAR FREE SWISS CHERRY HERB THROAT DROPSMENTHOLRicola Age2a939a5-4447-4707-865c-70de9a0471c62024-12-05WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola Agec6cad6b-9e92-44c9-a470-cf924fb1b6d72024-12-05WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNa50d4259-8a79-417e-b381-72c7a8ec04181
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDa50d4259-8a79-417e-b381-72c7a8ec04181
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYa50d4259-8a79-417e-b381-72c7a8ec04181
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYa50d4259-8a79-417e-b381-72c7a8ec04181
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYa50d4259-8a79-417e-b381-72c7a8ec04181
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYa50d4259-8a79-417e-b381-72c7a8ec04181
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYa50d4259-8a79-417e-b381-72c7a8ec04181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-130-60350000130601 TUBE in 1 CARTON (35000-130-60) / 170 g in 1 TUBE1 tube2026-01-01NoNoCurrent