FDA.reportPublic FDA data

Enamelon Preventive Treatment

Product NDC
48783-500
11-digit product format
487830500
Labeler code
48783
Product ID
48783-500_4847e624-6a03-7e43-e063-6394a90a5045
Type
HUMAN OTC DRUG
Nonproprietary name
stannous fluoride
Dosage form
GEL
Route
DENTAL
Labeler
Premier Dental Products Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-01
Substance
STANNOUS FLUORIDE
Active strength
.004 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 Preventive Treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.004 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
237847Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
04c3f178-7905-404d-9ac2-67c453287ddfAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48783-500-402023-02-01C16284748780-1f386c64a-0636-0266-e053-dadaa90a7c1aEnamelon Gel
48783-500-402023-01-30C16284748780-1f386c64a-0636-0266-e053-dadaa90a7c1aEnamelon Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48783-500-40Enamelon Preventive Treatment113 g in 1 TUBEGEL1138
48783-500-40Enamelon Preventive Treatment1 in 1 CARTONGEL18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STANNOUS FLUORIDEACTIVE INGREDIENT3FTR44B32QENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9ENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]2
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505ENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]2
CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%)INACTIVE INGREDIENT5216H1HX5FENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]2
LAUROYL SARCOSINEINACTIVE INGREDIENTLIJ19P3L6FENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]2
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4ENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48783-500ENAMELON PREVENTIVE TREATMENT (STANNOUS FLUORIDE) GEL [PREMIER DENTAL PRODUCTS COMPANY]7Current NDC, Legacy NDC, 2 package rows20241027_04c3f178-7905-404d-9ac2-67c453287ddf.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 24 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro Health Sensitive and Enamel ShieldSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb48b15c-f821-e5cd-e053-6294a90ac64c2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Luminous PurpleSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyfbfcd837-4d88-5f82-e053-6394a90afbf62026-01-08WarningsExact identifier
application number: M021
Crest Pro Health with a Touch of ScopeSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb572b41-36cd-55d7-e053-6394a90a71c82026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Whitening GelSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyfb5b1e94-bed6-8486-e053-6294a90a3a842026-01-08WarningsExact identifier
application number: M021
Crest 3D White Ultra Vivid MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companycba96ef0-0519-059f-e053-2a95a90a43ad2026-01-08WarningsExact identifier
application number: M021
Crest 4in1SODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyce545406-3c4f-1ba7-e053-2a95a90a91ac2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd218ddc0-1d5f-f39b-e053-2995a90a96ed2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Antibacterial ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd58bc842-2687-e52d-e053-2995a90a54332026-01-08WarningsExact identifier
application number: M021
Scope Stay StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd65b3153-2026-a8c0-e053-2a95a90a31d62026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Whitening CharcoalSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd6f68485-b92f-41c7-e053-2995a90a4fe52026-01-08WarningsExact identifier
application number: M021
KIDS Crest Advanced Enamel Plus Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd837ecde-249a-7868-e053-2a95a90a56ae2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Whitening Intensive CleaningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd6fa4187-a651-647b-e053-2995a90a85672026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Gum ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd7729dde-c828-34e6-e053-2a95a90a5ee62026-01-08WarningsExact identifier
application number: M021
Crest Densify Daily WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd811306f-4994-7a5a-e053-2995a90adf162026-01-08WarningsExact identifier
application number: M021
Crest Densify Daily ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd810d4e5-ba66-efe1-e053-2995a90abfc02026-01-08WarningsExact identifier
application number: M021
Crest Braces Care Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd823cba4-c4cf-7d7a-e053-2995a90a01f02026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Sensitive ReliefSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd7730674-7513-52cf-e053-2995a90ab32c2026-01-08WarningsExact identifier
application number: M021
Kids Crest Bubblegum FlavorSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company26a7a892-5da4-4749-bbb6-566efab7d7492026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Plus ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8c91095d-88c0-4d22-a79a-7d0f0d05302b2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Advanced Deep Clean MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd774295f-8ebd-9877-e053-2a95a90a9a0e2026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237847stannous fluoride 0.4 % Oral GelPSN04c3f178-7905-404d-9ac2-67c453287ddf8
237847stannous fluoride 0.004 MG/MG Oral GelSCD04c3f178-7905-404d-9ac2-67c453287ddf8
237847stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral GelSY04c3f178-7905-404d-9ac2-67c453287ddf8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48783-500-40487830500401 TUBE in 1 CARTON (48783-500-40) / 113 g in 1 TUBE1 tube2014-01-010000-00-00NoNoCurrent