Home NDC 50001-131 LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY
Product NDC 50001-131
11-digit product format 500010131
Labeler code 50001
Product ID 50001-131_acbdcd4b-ada1-4f89-9046-428b73844128
Type HUMAN OTC DRUG
Nonproprietary name POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE
Dosage form PASTE
Route DENTAL
Labeler LEVEL ORAL CARE, LLC
Application part356
Marketing category OTC MONOGRAPH FINAL
Marketing start 2010-08-12
Marketing end 0000-00-00
Substance POTASSIUM NITRATE; SODIUM MONOFLUOROPHOSPHATE
Active strength 5 g/100g; g/100g
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50001-131-50 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50001-131-50 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50001-131-50 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50001-131-50 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50001-131-50 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50001-131-50 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50001-131-50 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50001-131-50 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50001-131-50 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50001-131-50 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50001-131-50 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50001-131-50 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50001-131-50 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50001-131-50 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50001-131-50 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 50001-131-50 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 50001-131-50 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 50001-131-50 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 50001-131-50 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 50001-131-50 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 50001-131-50 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 50001-131-50 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 50001-131-50 LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY 141.7 g in 1 TUBE PASTE 141.7 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded POTASSIUM NITRATE ACTIVE INGREDIENT RU45X2JN0Z LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4 SODIUM MONOFLUOROPHOSPHATE ACTIVE INGREDIENT C810JCZ56Q LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4 FLUORIDE ION ACTIVE MOIETY Q80VPU408O LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4 POTASSIUM CATION ACTIVE MOIETY 295O53K152 LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4 SODIUM PYROPHOSPHATE INACTIVE INGREDIENT O352864B8Z LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4 SORBITOL INACTIVE INGREDIENT 506T60A25R LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50001-131 LEVEL HERBAL MINT FIVE SENSITIVE FORMULA ANTICAVITY (POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE) PASTE [LEVEL ORAL CARE, LLC] 4 Legacy NDC, 1 package rows 20110511_b3012fa7-5200-4607-9bc6-43326ff38dde.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 50001-131-50 50001013150 141.7 g in 1 TUBE 141.7 g Historical