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 42 of 49 · 972 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Brush Buddies Crayola Swirl ANTICAVITY FLUORIDE WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios, Inc. b3006c29-1f7f-4d9f-ab46-5a36df1a0471 2024-12-25 Warnings Exact identifier application number: M021 Listerine Total Care Zero Alcohol Anticavity Fresh Mint SODIUM FLUORIDE Kenvue Brands LLC 4b594a6e-db1d-443b-bfa7-23ee15749f47 2024-12-19 Warnings Exact identifier application number: M021 NewYork-Presbyterian Amenity SODIUM MONOFLUOROPHOSPATE ASP Global, LLc 4b307471-445d-4c51-a499-d074a8172f20 2024-12-17 Warnings Exact identifier application number: M021 Colgate Anticavity SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive (Thailand) Limited - Branch 5bc0b430-6f68-4e52-a1da-de19136eaeac 2024-12-09 Warnings Exact identifier application number: M021 CURODONT REPAIR FLUORIDE PLUS SODIUM FLUORIDE CREDENTIS AG 03ec09f9-4281-9ccb-e063-6294a90aadd8 2024-12-01 Warnings Exact identifier application number: M021 CURODONT PROTECT STANNOUS FLUORIDE CREDENTIS AG 03ec591c-68c3-a380-e063-6394a90a131a 2024-12-01 Warnings Exact identifier application number: M021 ACT Kids Anticavity Fluoride Bubble Gum Blowout SODIUM FLUORIDE Chattem, Inc. 61f3a3e6-645b-4368-b1d5-7de1fc14542e 2024-12-01 Warnings Exact identifier application number: M021 SparkleFresh Flouride Toothpaste SODIUM MONOFLUOROPHOSPHATE Medline Industries, LP 1565528b-89f2-4c97-b294-15b6ebd3f80e 2024-11-26 Warnings Exact identifier application number: M021 Rembrandt Intense Stain SODIUM FLUORIDE Ranir LLC 55dcd063-5661-35aa-e054-00144ff8d46c 2024-11-26 Warnings Exact identifier application number: M021 Firefly Anticavity Fluoride SODIUM FLUORIDE Ranir LLC 9f98913f-6754-4e1c-98cf-b89fe87750f8 2024-11-25 Warnings Exact identifier application number: M021 Colgate Total SF Clean Mint STANNOUS FLUORIDE Colgate-Palmolive Company 88f87f7a-5b2d-47c9-8830-6b88b4ddbb59 2024-11-25 Warnings Exact identifier application number: M021 Firefly Bubble Gum natural fluoride SODIUM FLUORIDE Ranir LLC 0c85d273-3b98-43ea-81ba-c90f70ab72f8 2024-11-25 Warnings Exact identifier application number: M021 Firefly Bubble Gum natural fluoride SODIUM FLUORIDE Ranir LLC 2a882210-49e6-4b9c-a2c6-eaa37b6514c3 2024-11-25 Warnings Exact identifier application number: M021 Pepsodent Complete Care Original SODIUM FLUORIDE Church & Dwight Co., Inc. 3c6931cb-0ec9-41bb-b410-c355573aab57 2024-11-21 Warnings Exact identifier application number: M021 Firefly Strawberry Natural Fluoride SODIUM FLUORIDE Ranir LLC 8ee37955-fe1a-4964-ac29-d1d7dfb694cc 2024-11-21 Warnings Exact identifier application number: M021 Firefly Anticavity Fluoride SODIUM FLUORIDE Ranir LLC abdc7f79-5f87-4307-8ddd-e6281ac67a04 2024-11-20 Warnings Exact identifier application number: M021 AIM Bubble Berry SODIUM FLUORIDE Church & Dwight Co., Inc. c83ccdea-d75f-4084-853e-ed4bab9a12d4 2024-11-20 Warnings Exact identifier application number: M021 AIM TARTAR CONTROL Plus Mouthwash and Whitening SODIUM FLUORIDE Church & Dwight Co., Inc. 1d0fc71c-d28e-4afa-e054-00144ff8d46c 2024-11-20 Warnings Exact identifier application number: M021 Advance White Tartar Control Breath Freshening SODIUM FLUORIDE Church & Dwight Co., Inc. aa8be8f5-ba46-4b1b-afaa-58fddf8f8780 2024-11-20 Warnings Exact identifier application number: M021 Enamel Defense SODIUM FLUORIDE Church & Dwight Co., Inc. 9e8f1ce9-b161-50db-e053-2995a90ad32b 2024-11-20 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 54473-340-01 54473034001 93.5 g in 1 TUBE (54473-340-01) 93.5 g 2022-11-10 0000-00-00 No No Current