FDA.reportPublic FDA data

Care One

Product NDC
41520-415
11-digit product format
415200415
Labeler code
41520
Product ID
41520-415_47e54e5e-4bd7-00ce-e063-6394a90a99e8
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
American Sales
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-01-20
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
.15; 5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage41520-415-098dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage41520-415-09e2bbac7714bc…27bdfed8d636…

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
Care One
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.15 g/100g
POTASSIUM NITRATE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal 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
1b6618ea-6533-41d7-be2c-13bb9e108dc5Available 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-03-105820110 Care One Max Str Sens Mint
2022-03-105820110 Care One Max Str Sens Mint
2020-09-275820110 Care One Max Str Sens Mint
2020-09-275820110 Care One Max Str Sens Mint
2020-09-255820110 Care One Max Str Sens Mint
2020-09-255820110 Care One Max Str Sens Mint
2020-07-225820110 Care One Max Str Sens Mint
2020-07-225820110 Care One Max Str Sens Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-415-02Care OneMaximum Strength113 g in 1 TUBEPASTE, DENTIFRICE1136
41520-415-09Care OneMaximum Strength1 in 1 CARTONPASTE, DENTIFRICE16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
NITRATE IONACTIVE MOIETYT93E9Y2844CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
SORBITOLINACTIVE INGREDIENT506T60A25RCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
WATERINACTIVE INGREDIENT059QF0KO0RCARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-415CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]5Current NDC, Legacy NDC, 2 package rows20250119_1b6618ea-6533-41d7-be2c-13bb9e108dc5.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 23 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.af430cf4-f1b4-4b57-b8e3-87df96d655d32025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.2b089fec-cae3-4dc9-964d-d37f732a2f9f2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.6c137a93-4a34-4849-997f-bd0c572466ef2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.e8aa9709-e8f6-47a6-ab29-1fef2309786b2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.8c55b39c-8231-46a1-92ef-9fb4e3f40c1e2025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.9e82dc54-aeca-457f-b4b9-2f18cc2695382025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.1a8f5964-770a-4d14-a7b6-18b5da9159b02025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722cdf3-7671-eb27-e053-2a95a90a09c42025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d722bf24-ae85-54f6-e053-2995a90a1d352025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721864d-0950-8379-e053-2a95a90a3bcb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalb0e5dc67-da7a-42ac-8657-e8e4da6914be2025-01-16WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.d721ff57-0111-4bbb-e053-2995a90a1a702025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International8129e871-5f31-4138-ae47-f8978fa6287f2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International0301c1bc-db48-4635-97f5-9eaef7ab95792025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalc0c88180-ccdc-4c48-b262-3ec20d4775d42025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent Internationalba011795-6822-4fff-b9c8-5c91cf9972a72025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International1c6d5e87-3fad-4a2c-9e5f-96166d0beaeb2025-01-16WarningsExact identifier
application number: M022
DefendBENZOCAINEMydent International462a5f09-131f-4dfa-a502-547c44e4a4a52025-01-16WarningsExact identifier
application number: M022
BenzocaineTOPICAL ANESTHETICEverpharm LLC2bc57111-0f15-b237-e063-6294a90a44712025-01-15WarningsExact identifier
application number: M022
Kanka Triple ActionBENZOCAINE AND MENTHOL, UNSPECIFIED FORMBlistex Inc.078fcdab-38a1-4a9a-bdd3-e17446591ea82025-01-09WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN1b6618ea-6533-41d7-be2c-13bb9e108dc56
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD1b6618ea-6533-41d7-be2c-13bb9e108dc56
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY1b6618ea-6533-41d7-be2c-13bb9e108dc56
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY1b6618ea-6533-41d7-be2c-13bb9e108dc56
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1b6618ea-6533-41d7-be2c-13bb9e108dc56
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1b6618ea-6533-41d7-be2c-13bb9e108dc56
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY1b6618ea-6533-41d7-be2c-13bb9e108dc56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-415-0241520041502113 g in 1 TUBE113 gHistorical
41520-415-09415200415091 TUBE in 1 CARTON (41520-415-09) / 113 g in 1 TUBE (41520-415-02) 1 tube2012-11-150000-00-00NoNoCurrent