FDA.reportPublic FDA data

NDC 44946-1032 - Sodium Fluoride

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
44946-1032
Package NDCs from labels
44946-1032-8
Manufacturer
Sancilio & Company Inc
Effective date
2018-03-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sodium Fluoride - Sancilio & Company IncSancilio & Company Inc2018-03-06DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44946-1032-8Sodium Fluoride50 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44946-1032SODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]51 package rows20180324_01013faa-33e3-48a4-b710-d996fac43b61.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44946-1032-8ML - Milliliter44946-10323caf5222-8075-4f8b-929e-be5157faad6312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7SODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
Fluoride IonACTIVE MOIETYQ80VPU408OSODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXSODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TSODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3SODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHSODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4SODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
WaterINACTIVE INGREDIENT059QF0KO0RSODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
XylitolINACTIVE INGREDIENTVCQ006KQ1ESODIUM FLUORIDE SOLUTION/ DROPS [SANCILIO & COMPANY INC]2

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 77 of 80 · 1,590 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zap APFSODIUM FLUORIDECrosstex International Inc.49ca4fc7-6f1a-47e7-9d0c-d015c9a3c2022022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.537d2b3f-d7e0-49c9-aaac-680f897b63a52022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Sodium Fluoride 5000 ppm FruitSODIUM FLUORIDESheffield Pharmaceuticals LLCa73f72b9-dbcd-4eed-9c20-46a9e8daf8592022-01-19Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PureLife APFSODIUM FLUORIDEPureLife Dental492a4a5b-a94d-4928-b0dd-976bb909c4762022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
PureLife APFSODIUM FLUORIDEPureLife Dental6d3e9f0f-f5e9-44ec-9688-86276d33a8a82022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
PureLife APFSODIUM FLUORIDEPureLife Dental615840e4-c108-4d68-b815-fc95ae75539c2022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
PureLife APFSODIUM FLUORIDEPureLife Dentalc8262117-43e6-4771-93ac-618e0f2c8c412022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
PureLife APFSODIUM FLUORIDEPureLife Dental44b91f76-1b7a-40fc-9c80-e1c915b3d2ca2022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Zap NeutralSODIUM FLUORIDECrosstex International Inc.e1dc8865-a193-44e7-b628-3c4e5d5953182022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.6c1907d6-5b22-40fc-b94e-42af7b5239022022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.fdf5c2e5-9939-448f-99ec-4de513e32fc12022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.c2d3d7f9-00cf-4d85-af51-71f150cd02892022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.080e7f9d-273e-4f3b-bc84-f7c0dd3cf94c2022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.01d48cbb-fbd6-477f-81ce-1e388718a4312022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.b1d799c6-e483-44fd-b07c-94ca2ee239ef2022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Gelato APFSODIUM FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.c33e0e2e-7c68-4908-8bd4-6a3669c8774b2022-01-19WarningsExact identifier
unii: 8ZYQ1474W7
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINTSODIUM FLUORIDEDMG AMERICA, LLCb83c62be-8e9d-4fa2-aa10-d34c88bf23872021-10-01WarningsExact identifier
unii: 8ZYQ1474W7
KOLORZ SIXTY SECOND FLUORIDE FOAM TRIPLE MINTSODIUM FLUORIDEDMG AMERICA, LLC427f25e6-e50a-407a-a6f0-512123e381e42021-10-01WarningsExact identifier
unii: 8ZYQ1474W7
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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