FDA.reportPublic FDA data

NDC 63404-1116-03 - SprinJene White Boost

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63404-1116
Requested NDC
63404-1116-03
Package NDCs from labels
63404-1116-1, 63404-1116-2, 63404-1116-3, 63404-1116-03
Manufacturer
Health and Natural Beauty USA Corp
Effective date
2026-08-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SprinJene White Boost - Health and Natural Beauty USA CorpHealth and Natural Beauty USA Corp2026-08-14HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
63404-1116-1SprinJene™ White Boost
63404-1116-1SprinJene™ White Boost
63404-1116-2SprinJene™ White Boost
63404-1116-2SprinJene™ White Boost

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63404-1116-1SprinJene White Boost1 in 1 CARTONPASTE, DENTIFRICE13
63404-1116-1SprinJene White Boost142 g in 1 TUBEPASTE, DENTIFRICE1423
63404-1116-2SprinJene White Boost1 in 1 CARTONPASTE, DENTIFRICE13
63404-1116-2SprinJene White Boost42 g in 1 TUBEPASTE, DENTIFRICE423

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63404-1116SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3Current NDC, Legacy NDC, 4 package rows20150213_8c401bea-0148-46a0-bbb3-80c17f9e8e3e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3
Fluoride IonACTIVE MOIETYQ80VPU408OSPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS311SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3
GlycerinINACTIVE INGREDIENTPDC6A3C0OXSPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3
Guizotia Abyssinica Seed OilINACTIVE INGREDIENTQX0GL46299SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3
Hydrated SilicaINACTIVE INGREDIENTY6O7T4G8P9SPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYSPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JSPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3
Sodium PyrophosphateINACTIVE INGREDIENTO352864B8ZSPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3
SorbitolINACTIVE INGREDIENT506T60A25RSPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPSPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3
WaterINACTIVE INGREDIENT059QF0KO0RSPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3
Xanthan GumINACTIVE INGREDIENTTTV12P4NEESPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3
Zinc CitrateINACTIVE INGREDIENTK72I3DEX9BSPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3
Zinc OxideINACTIVE INGREDIENTSOI2LOH54ZSPRINJENE WHITE BOOST (SODIUM FLUORIDE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP]3

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 335 · 6,700 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
unii: 8ZYQ1474W7
CrystLCare Regeneration PlusPOTASSIUM NITRATE, SODIUM FLUORIDEGreenMark Biomedical Inc.4f86d0a0-d73e-5605-e063-6394a90adb382026-09-14WarningsExact identifier
unii: 8ZYQ1474W7
Dermaka Infants and Kids Multi Purpose Skin ProtectantZINC OXIDEDermaka Skin Products LLCf84dfd55-db6c-4d75-be67-4d13a139e2092026-09-10WarningsExact identifier
unii: SOI2LOH54Z
Zinc OxideZINC OXIDECVS Pharmacy, Inc.35e67726-4527-4cd7-8e73-30325a32402c2026-09-09Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
TheraTearsCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC17a01236-130f-495b-9f8d-92b6a23b2dc52026-09-09WarningsExact identifier
unii: K679OBS311
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Opalescence Whitening Sensitivity ReliefPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.44e94663-895b-67da-e063-6394a90a5fe62026-09-09WarningsExact identifier
unii: 8ZYQ1474W7
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Opalescence Sensitivity Relief WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.b5176a84-76a3-4ad0-a2e2-4997a12da9a52026-09-09WarningsExact identifier
unii: 8ZYQ1474W7
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
Opal by Opalescence SensitivityPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.5ffc0d14-0290-47bb-90e5-90a25a5acc282026-09-09WarningsExact identifier
unii: 8ZYQ1474W7
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
unii: 8ZYQ1474W7
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
unii: 8ZYQ1474W7
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Colgate Optic White Stain Fighter Sens ReliefSODIUM FLUORIDEColgate-Palmolive Company6ec2fff7-df44-4302-be2d-97946c6cd66a2026-09-08WarningsExact identifier
unii: 8ZYQ1474W7
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
rxcui: 891775
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.