Home NDC 63404-0201 SprinJene
Product NDC 63404-0201
11-digit product format 634040201
Labeler code 63404
Product ID 63404-0201_d02d031a-f428-4114-b5f3-8a518ffc08cf
Type HUMAN OTC DRUG
Nonproprietary name Sodium Monofluorophosphate
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Health and Natural Beauty USA Corp
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-02-01
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength 1.5 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
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 · 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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 63404-0201-1 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.
Additional Listing Data#
Finished product Yes
Brand name base SprinJene
Brand name suffix Natural
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE 1.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545626 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 63404-0201-1 SprinJene Natural 99 g in 1 TUBE PASTE, DENTIFRICE 99 1 63404-0201-1 SprinJene Natural 1 in 1 CARTON PASTE, DENTIFRICE 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63404-0201 SPRINJENE NATURAL (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 1 Current NDC, Legacy NDC, 2 package rows 20170201_e64cecc3-0845-4bdf-a449-d78248791ccf.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 8 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Crest Plus Scope plus Whitening Minty Fresh with Mouthwash SODIUM FLUORIDE The Procter & Gamble Manufacturing Company 54ed8e02-3c2f-750c-e063-6394a90a4d33 2026-06-23 Warnings Exact identifier application number: M021 Anticavity Fluoride Rinse SODIUM FLUORIDE H E B c68b0644-685d-4c62-bf5d-3a5bbea3b052 2026-06-22 Warnings, Adverse reactions Exact identifier application number: M021 Tom Whole Care Peppermint fights cavities whitening fresh breath helps fight tartar SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. fdbadaae-eab7-4d9a-acf7-815ca93f877c 2026-06-16 Warnings Exact identifier application number: M021 Natural Fluoride Fresh Mint cavity protection whitening fresh breath SODIUM FLUORIDE Tom's of Maine, Inc. fce5e8b5-34f8-4a45-a662-82c903419809 2026-06-16 Warnings Exact identifier application number: M021 Toms Whole Care Spearmint fights cavities whitening fresh breath helps fight tartar SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. ebb62015-0027-459a-a9cf-56b640f9f456 2026-06-16 Warnings Exact identifier application number: M021 Toms Wicked Fresh Spearmint Ice fresh breath / cavity protection SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. b9962eac-186e-4da2-929d-393f18ed0234 2026-06-16 Warnings Exact identifier application number: M021 Toms Wicked Fresh Cool Peppermint fresh breath / cavity protection SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 1c029b10-29b0-4131-9134-cebfca4328a3 2026-06-16 Warnings Exact identifier application number: M021 Toms Whole Care Cinnamon Clove FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR SODIUM MONOFLUOROPHOSPHATE Tom's of Maine, Inc. 3e7ab39a-989c-4924-af3e-689404912bee 2026-06-16 Warnings Exact identifier application number: M021 Crest Plus Cinnamon plus Whitening SODIUM FLUORIDE The Procter & Gamble Manufacturing Company 53fb780d-3e8b-6747-e063-6294a90a8211 2026-06-11 Warnings Exact identifier application number: M021 Colgate Total SF Whitening STANNOUS FLUORIDE COLGATE PALMOLIVE COMPANY 7f6b6aa8-50da-151b-c448-9e427d37398f 2026-06-11 Warnings Exact identifier application number: M021 Colgate MaxClean with Whitening Smartfoam SODIUM FLUORIDE Colgate-Palmolive Company c712ae6b-eff3-4c54-b1fc-37304758d059 2026-06-11 Warnings Exact identifier application number: M021 Colgate Total Sensitivity Mineral Shield STANNOUS FLUORIDE Colgate-Palmolive Company f065318c-1e2a-c04d-f254-f8127b05a88f 2026-06-10 Warnings Exact identifier application number: M021 Toms Whole Care Mouthwash Fresh Mint SODIUM FLUORIDE Tom's of Maine, Inc. 6875f5c1-853c-43da-8226-c09a5518f9bb 2026-06-10 Warnings Exact identifier application number: M021 Colgate Total SF Fresh Mint Stripe STANNOUS FLUORIDE COLGATE PALMOLIVE COMPANY 657020c7-e85c-4c61-9f62-b50351e4b4e5 2026-06-10 Warnings Exact identifier application number: M021 Optimax Anticavity Fluoride Bubblegum SODIUM MONOFLUOROPHOSPHATE White Glo USA Inc 1adc752b-2ba8-4d8f-b4f1-5741f864255b 2026-06-09 Warnings Exact identifier application number: M021 Kids Crest Cavity Protection Sparkle Fun SODIUM FLUORIDE Procter & Gamble Manufactura, S. de R.L. de C.V. df182c22-bbf1-448d-81e8-35cb431d2afc 2026-06-08 Warnings Exact identifier application number: M021 PEROXICARE SODIUM FLUORIDE Church & Dwight Co., Inc. 55262538-15ce-455c-93b1-bb02b5f81d6b 2026-06-07 Warnings Exact identifier application number: M021 Optimax Anticavity Fluoride Raspberry SODIUM MONOFLUOROPHOSPHATE White Glo USA Inc 57e1d1cb-da58-4cd2-b960-4056e0b0d214 2026-06-05 Warnings Exact identifier application number: M021 3ECARE Dual FormulaWhiteningToothpaste SODIUM FLUORIDE Hangzhou Namei Zhikang Technology Co., Ltd. 533fb7dd-7f84-59c5-e063-6394a90accad 2026-06-02 Warnings Exact identifier application number: M021 3ECARE Dual FormulaToothpastefor sensitiveteeth POTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATE Hangzhou Namei Zhikang Technology Co., Ltd. 533fc83e-a8cf-15c1-e063-6294a90a7b74 2026-06-02 Warnings Exact identifier application number: M021
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63404-0201-1 63404020101 1 TUBE in 1 CARTON (63404-0201-1) / 99 g in 1 TUBE 1 tube 2017-02-01 No No Current