Home NDC 41520-415 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 41520-415-09 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 41520-415-09 e2bbac7714bc…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 Ingredient Strength SODIUM FLUORIDE .15 g/100g POTASSIUM NITRATE 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1038929 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41520-415-02 Care OneMaximum Strength 113 g in 1 TUBE PASTE, DENTIFRICE 113 6 41520-415-09 Care OneMaximum Strength 1 in 1 CARTON PASTE, DENTIFRICE 1 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POTASSIUM NITRATE ACTIVE INGREDIENT RU45X2JN0Z CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES] 1 SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES] 1 FLUORIDE ION ACTIVE MOIETY Q80VPU408O CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES] 1 NITRATE ION ACTIVE MOIETY T93E9Y2844 CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES] 1 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES] 1 SODIUM PHOSPHATE, TRIBASIC INACTIVE INGREDIENT A752Q30A6X CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41520-415 CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES] 5 Current NDC, Legacy NDC, 2 package rows 20250119_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 14 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41520-415-02 41520041502 113 g in 1 TUBE 113 g Historical 41520-415-09 41520041509 1 TUBE in 1 CARTON (41520-415-09) / 113 g in 1 TUBE (41520-415-02) 1 tube 2012-11-15 0000-00-00 No No Current