Home NDC 54473-337 Exceed Total Care Sensitive
Product NDC 54473-337
11-digit product format 544730337
Labeler code 54473
Product ID 54473-337_4746b4ab-584f-7572-e063-6394a90a971d
Type HUMAN OTC DRUG
Nonproprietary name Potassium Nitrate and Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route TOPICAL
Labeler Melaleuca, Inc
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-01-08
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength .2272; 4.675 g/93.5g; g/93.5g
NDC exclude flag No
Listing certified through 2026-12-31
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 · 6 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 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 54473-337-04 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 54473-337-04 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 54473-337-04 1332a3947898…d4bfe170f9cd…
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 Exceed Total Care Sensitive
Brand name suffix Spearmint Tooth Polish
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE .2272 g/93.5g SODIUM FLUORIDE 4.675 g/93.5g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RU45X2JN0Z Internal UNII lookup 8ZYQ1474W7 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54473-337-04 Exceed Total Care SensitiveSpearmint Tooth Polish 93.5 g in 1 TUBE PASTE, DENTIFRICE 93.5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54473-337 EXCEED TOTAL CARE SENSITIVE SPEARMINT TOOTH POLISH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [MELALEUCA, INC] 2 Current NDC, Legacy NDC, 1 package rows 20240529_dc620d3f-880f-df05-e053-2995a90a8409.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 48 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE LG H&H CO., LTD. 13910b55-9b5d-af53-e063-6294a90acf5d 2024-03-13 Warnings Exact identifier application number: M021 BIO SPECTRA ATTITUDE SODIUM FLUORIDE 9055-7588 Quebec Inc. DBA Attitude e3bb60f8-2a06-42d6-a182-8c31bb982a2a 2024-03-01 Warnings Exact identifier application number: M021 Maximum Security SODIUM FLUORIDE Bob Barker Company Inc. e29f30ec-72ea-4944-a2c2-b1696d31b639 2024-02-27 Warnings Exact identifier application number: M021 Made by Dentists For Kids Monster Slime Sour Apple SODIUM FLUORIDE MADE BY DENTISTS INC dfddc67c-3626-48c4-8120-bcc6c455d119 2024-02-23 Warnings Exact identifier application number: M021 Orajel Gabbys Dollhouse SODIUM FLUORIDE Church & Dwight Co., Inc. cd47bd1e-44ac-465f-8529-6073ade14706 2024-02-23 Warnings Exact identifier application number: M021 Colgate Kids Maximum Cavity Protection SODIUM FLUORIDE Colgate-Palmolive c44c7a7e-fc3e-a81b-1961-ff89614b678f 2024-02-22 Warnings Exact identifier application number: M021 TheraBreath Fresh Breath Anticavity Mild Mint SODIUM FLUORIDE Church & Dwight Co., Inc. 19ce5324-7d8d-4d70-ad9b-238f7e612eac 2024-02-06 Warnings Exact identifier application number: M021 Nature Mint Anticavity SODIUM MONOFLUOROPHOSPHATE Bob Barker Company Inc. 916891d3-5234-46a8-a492-21a31f36a852 2024-02-02 Warnings Exact identifier application number: M021 Treatment Rinse Mint ANTICARIES DENTAL ALLIANCE HOLDINGS LLC f1255065-b7c3-4eb6-e053-2995a90afcdb 2024-01-31 Warnings Exact identifier application number: M021 Maintenance Rinse Mint ANTICARIES Dental Alliance Holdings LLC f1273510-aa83-3ef9-e053-2a95a90aea27 2024-01-31 Warnings Exact identifier application number: M021 ATOMY PROPOLIS TOOTHPAS TE 50G SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE ATOMY CO., LTD. 98d839e3-a1aa-c83d-e053-2995a90a7e79 2024-01-30 Warnings Exact identifier application number: M021 ATOMY PROPOLIS TOOTHPAS TE 200G SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE ATOMY CO., LTD. 98aebbec-aec0-1478-e053-2a95a90a03ea 2024-01-30 Warnings Exact identifier application number: M021 Toms Childrens Anticavity Mouthwash Silly Strawberry SODIUM FLUORIDE Tom's of Maine, Inc. 998c6f35-20f4-4cb8-bc48-6aa39e61481a 2024-01-18 Warnings Exact identifier application number: M021 Gel-Kam Fruit and Berry STANNOUS FLUORIDE Colgate Oral Pharmaceuticals, Inc. 8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c 2024-01-18 Warnings Exact identifier application number: M021 Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride SODIUM FLUORIDE Colgate Oral Pharmaceuticals, Inc. 9a976ac8-d966-4d94-93da-45652f2d2481 2024-01-12 Warnings Exact identifier application number: M021 Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride SODIUM FLUORIDE Colgate Oral Pharmaceuticals, Inc. 2b4b6f9a-0e31-4891-8721-d1b9a58cca96 2024-01-12 Warnings Exact identifier application number: M021 Colgate MaxFresh with Mini Breath Cool Mint SODIUM FLUORIDE Colgate-Palmolive Company 51abd6bc-7a3d-4b0e-a810-af9e94926438 2024-01-09 Warnings Exact identifier application number: M021 Colgate Enamel Strength Mouthwash SODIUM FLUORIDE Colgate-Palmolive - do not use f0cca38b-c0a3-4788-8cca-727a5684c16b 2024-01-09 Warnings Exact identifier application number: M021 PerCara Oral Health Rinse Fresh Mint CETYLPYRIDINIUM CHLORIDE LEC Custom Products, Inc bd98c654-218b-15ac-e053-2a95a90a75d1 2024-01-01 Warnings Exact identifier application number: M021 PerCara Kids Bubble Gum SODIUM FLUORIDE LEC Custom Products, Inc. be3a7272-acfb-7d14-e053-2995a90a9420 2024-01-01 Warnings Exact identifier application number: M021
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54473-337-04 54473033704 93.5 g in 1 TUBE (54473-337-04) 93.5 g 2022-01-08 0000-00-00 No No Current