FDA.reportPublic FDA data

Enamelon

Product NDC
48783-520
11-digit product format
487830520
Labeler code
48783
Product ID
48783-520_4847e71b-2083-917b-e063-6394a90a2df0
Type
HUMAN OTC DRUG
Nonproprietary name
stannous fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Premier Dental Products Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-01
Substance
STANNOUS FLUORIDE
Active strength
.00454 g/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
Enamelon
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.00454 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416784Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1626375a-f78b-4192-b7f3-ca932acab7fbAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
48783-520-082023-02-01Enamelon Paste
48783-520-432023-02-01Enamelon Paste
48783-520-082023-01-30Enamelon Paste
48783-520-432023-01-30Enamelon Paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48783-520-43Enamelon122 g in 1 TUBEPASTE, DENTIFRICE1227
48783-520-43Enamelon1 in 1 CARTONPASTE, DENTIFRICE17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STANNOUS FLUORIDEACTIVE INGREDIENT3FTR44B32QENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1
CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%)INACTIVE INGREDIENT5216H1HX5FENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1
LAUROYL SARCOSINEINACTIVE INGREDIENTLIJ19P3L6FENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48783-520ENAMELON (STANNOUS FLUORIDE) PASTE, DENTIFRICE [PREMIER DENTAL PRODUCTS COMPANY]6Current NDC, Legacy NDC, 2 package rows20241027_1626375a-f78b-4192-b7f3-ca932acab7fb.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 13 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.ed617c7a-805c-4788-9bce-9b7fead4312d2026-03-31WarningsExact identifier
application number: M021
Colgate Total Enamel StrengthSTANNOUS FLUORIDEColgate-Palmolive Company1f29c893-e7c5-4a0e-941b-c2634d8211472026-03-25WarningsExact identifier
application number: M021
AP-24 WhiteningSODIUM MONOFLUOROPHOSPHATENSE Products, Inc.57e9e68c-41dd-470b-80db-dfaedc0e2a0a2026-03-24WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369c0d44-6375-dcae-e063-6394a90a74d02026-03-24WarningsExact identifier
application number: M021
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369bc785-fb77-a56d-e063-6394a90a2e6b2026-03-24WarningsExact identifier
application number: M021
SensitiveToothpasteANTI SENSITIVETOOTHPASTEHuain Best Trade Co., Ltd.4db239f3-2ad7-3a5b-e063-6294a90a11a72026-03-23WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d6268c7-b273-1bbf-e053-2a91aa0a5d322026-03-17WarningsExact identifier
application number: M021
Natures Promise Childrens Fluoride StrawberrySODIUM MONOFLUOROPHOSPHATEFoodhold U.S.A.81a4e196-8b2d-0745-e053-2991aa0a7de62026-03-16WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae8badf-f960-62fd-e054-00144ff8d46c2026-03-11WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae71258-a8c2-6eb5-e054-00144ff88e882026-03-11WarningsExact identifier
application number: M021
Delta Travel Kit Comfort plusSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.d31e0920-4317-1e0c-e053-2a95a90aebeb2026-03-11WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.eac346d9-d9c1-4417-8193-390c7a0dcc2a2026-03-10Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6caf3f2e-70a2-4530-99fa-f5af7e4c511a2026-03-10WarningsExact identifier
application number: M021
Amerfresh ToothpowderSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD1cacf93e-aa60-4717-87ab-0568a701a4f32026-03-10WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.a51357df-6d55-4030-a5db-42da7ba54a372026-03-09Warnings, Adverse reactionsExact identifier
application number: M021
FluorideFLUORIDE TOOTHPASTEMcKesson4c482e45-0502-a93a-e063-6394a90aa9612026-03-05WarningsExact identifier
application number: M021
Colgate Maximum Cavity Protection Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company0a1389f6-cac9-3d58-0744-c488abb0bbcc2026-03-03WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEAmazon.com Services LLC349eca80-2e0c-409b-af29-3235fdc0695b2026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEAmazon.com Services LLC03735abc-d1be-4ca0-a497-0a5c5f2894022026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.f8036e2e-7541-4922-92b9-0d8319f7b64c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN1626375a-f78b-4192-b7f3-ca932acab7fb7
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD1626375a-f78b-4192-b7f3-ca932acab7fb7
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY1626375a-f78b-4192-b7f3-ca932acab7fb7
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY1626375a-f78b-4192-b7f3-ca932acab7fb7
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY1626375a-f78b-4192-b7f3-ca932acab7fb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48783-520-08487830520081 TUBE in 1 CARTON (48783-520-08) > 21.2 g in 1 TUBE1 tube2014-01-010000-00-00NoNoCurrent
48783-520-43487830520431 TUBE in 1 CARTON (48783-520-43) / 122 g in 1 TUBE1 tube2014-01-010000-00-00NoNoCurrent