Home NDC 54473-340 Exceed Total Care Sensitive
Product NDC 54473-340
11-digit product format 544730340
Labeler code 54473
Product ID 54473-340_4746c0b9-4fe7-626b-e063-6394a90a3291
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 54473-340-01 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 54473-340-01 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 54473-340-01 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 Peppermint 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 54473-340-01 Exceed Total Care SensitivePeppermint 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 54473-340 EXCEED TOTAL CARE SENSITIVE PEPPERMINT TOOTH POLISH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [MELALEUCA, INC] 2 Current NDC, Legacy NDC, 1 package rows 20240529_ed2179a4-3d19-6481-e053-2995a90ad655.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 30 of 49 · 974 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MIPaste One Perio MIPASTE ONE PERIO GC America Inc. d656b72d-48f8-4425-e053-2995a90ab1f2 2025-12-19 Warnings Exact identifier application number: M021 MIPaste One Kids Blue Raspberry MIPASTE ONE KIDS BLUE RASPBERRY GC America Inc. c07e1058-903b-fd47-e053-2995a90afdab 2025-12-19 Warnings Exact identifier application number: M021 MIPaste Plus Strawberry MIPASTE PLUS STRAWBERRY GC America Inc. d7235ad7-83d7-12e5-e053-2a95a90aaeaf 2025-12-19 Warnings Exact identifier application number: M021 MIPaste One Kids Cotton Candy MIPASTE ONE KIDS COTTON CANDY GC America Inc. c07d6b50-1d67-ea7f-e053-2a95a90afbe4 2025-12-19 Warnings Exact identifier application number: M021 MIPaste One Kids Bubble Gum MIPASTE ONE KIDS BUBBLE GUM GC America Inc. c07c7853-763b-4383-e053-2995a90ab725 2025-12-19 Warnings Exact identifier application number: M021 MIPaste One MIPASTE ONE GC America Inc. d71f8e6e-7005-4b3e-e053-2995a90a6789 2025-12-19 Warnings Exact identifier application number: M021 TheraBreath AM-PM Twin Pack SODIUM FLUORIDE Church & Dwight Co., Inc. 4618e390-9039-a1d0-e063-6294a90ab294 2025-12-16 Warnings Exact identifier application number: M021 Parodontax Gum Strengthen and Protect STANNOUS FLUORIDE Haleon US Holdings LLC 3bb40ceb-841b-4a25-e063-6294a90ab897 2025-12-15 Warnings Exact identifier application number: M021 Sensodyne Pronamel Kids Bubble Mint SODIUM FLUORIDE Haleon US Holdings LLC 41b1e626-e79b-d638-e063-6394a90a1f5b 2025-12-15 Warnings Exact identifier application number: M021 Simple Truth Kids Flouride SODIUM MONOFLUOROPHOSPHATE Kroger Company 82b9db89-d108-3f64-e053-2991aa0aee74 2025-12-15 Warnings Exact identifier application number: M021 Natural Adult Fluoride SODIUM MONOFLUOROPHOSPHATE Kroger a71c537e-39d9-1c3b-e053-2a95a90ac3ec 2025-12-15 Warnings Exact identifier application number: M021 Therabreath Overnight Chamomile Mint SODIUM FLUORIDE Church & Dwight Co., Inc. cc0c533c-145e-4877-b421-1baf3a3a572e 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 188d28f9-a814-0f98-e063-6294a90a106b 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b4cf935-38a6-f4fb-e063-6394a90a4bc0 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 188cddb2-c799-0897-e063-6294a90a5d96 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1ba491f4-2ad2-6e7b-e063-6394a90a9fb7 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 188ac743-3ba8-4da4-e063-6294a90a8f87 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b682604-c563-01f1-e063-6294a90ab0bd 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b110db1-fcc0-377f-e063-6394a90a4d44 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1b74ecc4-a1e6-348f-e063-6294a90a5894 2025-12-11 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 54473-340-01 54473034001 93.5 g in 1 TUBE (54473-340-01) 93.5 g 2022-11-10 0000-00-00 No No Current