FDA.reportPublic FDA data

SprinJene

Product NDC
63404-0910
Requested package NDC
63404-0910-3
11-digit product format
634040910
Labeler code
63404
Product ID
63404-0910_8a4e6021-6529-4cfd-ab1a-0f756a9be87b
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL, 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

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
Fresh Boost
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
891775Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
919f6f51-6c43-4f1c-9bc7-029bf76c0e68Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63404-0910-12025-01-30SprinJene™ Fresh Boost
63404-0910-12025-01-30SprinJene™ Fresh Boost
63404-0910-22025-01-30SprinJene™ Fresh Boost
63404-0910-22025-01-30SprinJene™ Fresh Boost
63404-0910-12023-02-22SprinJene™ Fresh Boost
63404-0910-12023-02-22SprinJene™ Fresh Boost
63404-0910-22023-02-22SprinJene™ Fresh Boost
63404-0910-22023-02-22SprinJene™ Fresh Boost
63404-0910-12020-01-31SprinJene™ Fresh Boost
63404-0910-12020-01-31SprinJene™ Fresh Boost
63404-0910-22020-01-31SprinJene™ Fresh Boost
63404-0910-22020-01-31SprinJene™ Fresh Boost

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63404-0910-1SprinJene Fresh Boost1 in 1 CARTONGEL, DENTIFRICE13
63404-0910-1SprinJene Fresh Boost130 g in 1 TUBEGEL, DENTIFRICE1303
63404-0910-2SprinJene Fresh Boost42 g in 1 TUBEGEL, DENTIFRICE423
63404-0910-2SprinJene Fresh Boost1 in 1 CARTONGEL, DENTIFRICE13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7SPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
Fluoride IonACTIVE MOIETYQ80VPU408OSPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS311SPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDSPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MSPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXSPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
Guizotia Abyssinica Seed OilINACTIVE INGREDIENTQX0GL46299SPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
Hydrated SilicaINACTIVE INGREDIENTY6O7T4G8P9SPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
MicaINACTIVE INGREDIENTV8A1AW0880SPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYSPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JSPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
Sodium PyrophosphateINACTIVE INGREDIENTO352864B8ZSPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
SorbitolINACTIVE INGREDIENT506T60A25RSPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
WaterINACTIVE INGREDIENT059QF0KO0RSPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
Xanthan GumINACTIVE INGREDIENTTTV12P4NEESPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2
Zinc CitrateINACTIVE INGREDIENTK72I3DEX9BSPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63404-0910SPRINJENE FRESH BOOST (SODIUM FLUORIDE) GEL, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3Current NDC, Legacy NDC, 4 package rows20230223_919f6f51-6c43-4f1c-9bc7-029bf76c0e68.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 1 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN919f6f51-6c43-4f1c-9bc7-029bf76c0e683
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD919f6f51-6c43-4f1c-9bc7-029bf76c0e683
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY919f6f51-6c43-4f1c-9bc7-029bf76c0e683
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY919f6f51-6c43-4f1c-9bc7-029bf76c0e683
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY919f6f51-6c43-4f1c-9bc7-029bf76c0e683
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY919f6f51-6c43-4f1c-9bc7-029bf76c0e683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63404-0910-3634040910031 TUBE in 1 CARTON (63404-0910-3) / 75 g in 1 TUBE1 tube2026-01-01NoNoCurrent