Home NDC 63404-1108-2 SprinJene
Product NDC 63404-1108
Requested package NDC 63404-1108-2
11-digit product format 634041108
Labeler code 63404
Product ID 63404-1108_2c7c212f-b7da-47a0-bbfb-73fd530e252a
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 2016-07-01
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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 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 Health Boost
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 63404-1108-1 SprinJene Health Boost 142 g in 1 TUBE PASTE, DENTIFRICE 142 3 63404-1108-1 SprinJene Health Boost 1 in 1 CARTON PASTE, DENTIFRICE 1 3 63404-1108-2 SprinJene Health Boost 42 g in 1 TUBE PASTE, DENTIFRICE 42 3 63404-1108-2 SprinJene Health Boost 1 in 1 CARTON PASTE, DENTIFRICE 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63404-1108 SPRINJENE HEALTH BOOST (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Current NDC, Legacy NDC, 4 package rows 20230223_9be87bcd-403a-4d7e-8ded-9833249565d1.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 31 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 1b68315c-6afa-3f37-e063-6294a90a14e8 2025-12-11 Warnings Exact identifier application number: M021 ANTICAVITY FLUORIDE SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 295b88e8-c4b5-c0b0-e063-6394a90aca01 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1b74f072-c33b-c6e2-e063-6394a90ab1e6 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1ba4a807-d6d5-04a0-e063-6294a90ae04d 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b617f4a-b56c-9f75-e063-6294a90a7abe 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 1b9ec370-eadf-92c4-e063-6294a90a9055 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FALVOR SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1eb04296-ecb1-3ccc-e063-6294a90a9bda 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b9e7b21-0d34-74ec-e063-6294a90a1f59 2025-12-11 Exact identifier application number: M021 Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash SODIUM FLUORIDE Kenvue Brands LLC 28986d7f-3e9a-8dfb-e063-6394a90a731e 2025-12-10 Warnings Exact identifier application number: M021 Toms of Maine Tropical Island ALUMINUM CHLOROHYDRATE Colgate-Palmolive Company 0d6c51bc-5391-4533-b4fd-961dc4f36342 2025-12-10 Warnings Exact identifier application number: M021 Business Class Kit SODIUM MONOFLUOROPHOSPHATE American Airlines, Inc. 483d7aec-34ac-49c5-ac0e-8fba5b4737ae 2025-12-09 Warnings Exact identifier application number: M021 Colgate Anticavity Kit SODIUM MONOFLUOROPHOSPHATE Ming Fai Industrial (Shenzhen) Co. Ltd 121decce-c364-4060-87da-0c6a6cd48474 2025-12-08 Warnings Exact identifier application number: M021 First Class Kit SODIUM MONOFLUOROPHOSPHATE American Airlines, Inc. ba717de8-c3a2-41bf-85a1-aa75f9744d30 2025-12-08 Warnings Exact identifier application number: M021 United Airlines Business Class Kit SODIUM MONOFLUOROPHOSPHATE United Airlines 94c5e9a4-19f3-4590-9da4-313c75261231 2025-12-08 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Nano-Hydroxyapatite SODIUM FLUORIDE Dr Jen Natural, LLC 5f08d994-e458-42b2-aa39-e84fca3acf48 2025-12-05 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 63404-1108-2 63404110802 1 TUBE in 1 CARTON (63404-1108-2) / 42 g in 1 TUBE 1 tube 2016-07-01 No No Current