Home NDC 63404-1116-2 SprinJene
Product NDC 63404-1116
Requested package NDC 63404-1116-2
11-digit product format 634041116
Labeler code 63404
Product ID 63404-1116_b7ffb349-2a06-4ff7-b8bc-0c9975b47c83
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Health and Natural Beauty USA Corp
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-10-10
Substance SODIUM FLUORIDE
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 · 22 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 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…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 White Boost
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 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 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 891775 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 63404-1116-1 SprinJene White Boost 1 in 1 CARTON PASTE, DENTIFRICE 1 3 63404-1116-1 SprinJene White Boost 142 g in 1 TUBE PASTE, DENTIFRICE 142 3 63404-1116-2 SprinJene White Boost 1 in 1 CARTON PASTE, DENTIFRICE 1 3 63404-1116-2 SprinJene White Boost 42 g in 1 TUBE PASTE, DENTIFRICE 42 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Sodium Fluoride ACTIVE INGREDIENT 8ZYQ1474W7 SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Fluoride Ion ACTIVE MOIETY Q80VPU408O SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Carboxymethylcellulose Sodium INACTIVE INGREDIENT K679OBS311 SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Glycerin INACTIVE INGREDIENT PDC6A3C0OX SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Guizotia Abyssinica Seed Oil INACTIVE INGREDIENT QX0GL46299 SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Hydrated Silica INACTIVE INGREDIENT Y6O7T4G8P9 SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Sodium Lauryl Sulfate INACTIVE INGREDIENT 368GB5141J SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Sodium Pyrophosphate INACTIVE INGREDIENT O352864B8Z SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Sorbitol INACTIVE INGREDIENT 506T60A25R SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Water INACTIVE INGREDIENT 059QF0KO0R SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Xanthan Gum INACTIVE INGREDIENT TTV12P4NEE SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Zinc Citrate INACTIVE INGREDIENT K72I3DEX9B SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Zinc Oxide INACTIVE INGREDIENT SOI2LOH54Z SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63404-1116 SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] 3 Current NDC, Legacy NDC, 4 package rows 20150213_8c401bea-0148-46a0-bbb3-80c17f9e8e3e.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 5 of 50 · 995 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63404-1116-2 63404111602 1 TUBE in 1 CARTON (63404-1116-2) / 42 g in 1 TUBE 1 tube 2014-10-10 No No Current