Home NDC 63404-1984 SprinJene Natural
Product NDC 63404-1984
11-digit product format 634041984
Labeler code 63404
Product ID 63404-1984_4e23f203-d473-4e73-ab56-d9270e4c49e9
Type HUMAN OTC DRUG
Nonproprietary name Potassium Nitrate
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Health and Natural Beauty USA Corp
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-20
Substance POTASSIUM NITRATE
Active strength 50 mg/g
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 · 26 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 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63404-1984-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63404-1984-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63404-1984-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63404-1984-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63404-1984-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63404-1984-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63404-1984-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63404-1984-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63404-1984-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63404-1984-1 557ba5c1ecfa…9c80585c8c6e…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 63404-1984-1 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 63404-1984-1 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 63404-1984-1 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 SprinJene Natural
Brand name suffix Sensitivity and Gum
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 50 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 312544 Internal RxNorm 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 63404-1984-1 SprinJene Natural Sensitivity and Gum 142 g in 1 TUBE PASTE, DENTIFRICE 142 2 63404-1984-1 SprinJene Natural Sensitivity and Gum 1 in 1 CARTON PASTE, DENTIFRICE 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63404-1984 SPRINJENE NATURAL SENSITIVITY AND GUM (POTASSIUM NITRATE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 1 Current NDC, Legacy NDC, 2 package rows 20210220_3cb23e36-0e8c-4172-b4ae-859b58a2739f.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 34 of 40 · 782 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Orajel 2X Medicated Gel ORAL PAIN RELIEVER Church & Dwight Co., Inc. 262be295-4eaf-3136-e063-6294a90a7dcc 2024-11-05 Warnings Exact identifier application number: M022 BIOTENE Fresh Mint Original SODIUM FLUORIDE Haleon US Holdings LLC 1101c17f-c848-4cd5-a7cd-679b59dbe1bf 2024-11-05 Warnings Exact identifier application number: M022 biotene SODIUM MONOFLUOROPHOSPHATE Haleon US Holdings LLC a47a6502-efb2-4072-9562-cbe293531c2b 2024-11-04 Warnings Exact identifier application number: M022 Amosan Oral Wound Cleanser Cherry SODIUM PERBORATE MONOHYDRATE Vintage Brands Limited a0e145c8-6b08-40be-ae4f-5678c4a78b1e 2024-10-30 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043bfbc3-c33b-78b7-e063-6294a90a1a5a 2024-10-29 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043bfbc3-c33a-78b7-e063-6294a90a1a5a 2024-10-29 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043a3cb4-f560-0ffd-e063-6394a90a2ff6 2024-10-29 Warnings Exact identifier application number: M022 Amosan Oral Wound Cleanser Mint SODIUM PERBORATE MONOHYDRATE Vintage Brands Limited be57ca56-834f-4170-a407-f193484d8b0a 2024-10-29 Warnings Exact identifier application number: M022 SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint SODIUM FLUORIDE Haleon US Holdings LLC 817c0dad-d109-428e-adb5-3354604acc94 2024-10-28 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 1f3d68f6-afd6-42e7-b3e5-210228c8e7de 2024-10-28 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals LLC 0dd15227-6603-42ac-9a5f-f2dc49e0382a 2024-10-28 Warnings, Adverse reactions Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 0605d5d6-82bd-415e-b5cb-e273f934a4a7 2024-10-28 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Liquid BENZOCAINE Beutlich Pharmaceuticals, LLC f70fa3fc-cd65-4a80-9efd-129e98fd3998 2024-10-28 Warnings Exact identifier application number: M022 Sore Throat Relief Menthol PHENOL Chain Drug Consortium af661ef0-cdc3-4146-8ae5-59795aa49650 2024-10-28 Warnings Exact identifier application number: M022 Sore Throat Relief Cherry Flavor PHENOL Chain Drug Consortium a9cf9829-4b70-44fa-9719-240b65c06724 2024-10-28 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE PHARMACY VALUE ALLIANCE, LLC 85ae80c1-2bc2-4c90-9559-63510d03e739 2024-10-28 Warnings Exact identifier application number: M022 Chloraspetic MENTHOL AND BENZOCAINE Prestige Brands Holdings, Inc. 2b1808b2-2574-4ab8-a762-5733251848ce 2024-10-25 Warnings Exact identifier application number: M022 Chloraseptic Warming Sore Throat PHENOL Prestige Brands Holdings, Inc. a197fab2-70ce-4a6c-9add-29d7368a75c5 2024-10-25 Warnings Exact identifier application number: M022 Gly-Oxide CARBAMIDE PEROXIDE Medtech Products Inc. 086a0b82-e947-41c9-89e7-ba06483960c9 2024-10-25 Warnings Exact identifier application number: M022 CHLORASEPTIC MENTHOL AND BENZOCAINE Prestige Brands Holdings, Inc. d500f423-b9f2-4d98-8f2a-8bab7c05737c 2024-10-25 Warnings Exact identifier application number: M022
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 63404-1984-1 63404198401 1 TUBE in 1 CARTON (63404-1984-1) / 142 g in 1 TUBE 1 tube 2021-02-20 0000-00-00 No No Current