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 78 of 80 · 1,590 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Wentworth Alcohol FreeSODIUM FLUORIDESheffield Pharmaceuticals LLC5ed816ef-20bc-49ac-9202-8fac1edac5792021-03-23Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sodium Fluoride 5000 ppm Dry MouthSODIUM FLUORIDESheffield Pharmaceuticals LLCcbc67f03-55c4-4781-ba37-87c737b602822021-03-02Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, Inc.ab9b07ad-f6b2-4289-bec4-fec58270dc972021-02-20WarningsExact identifier
unii: 8ZYQ1474W7
AvantSODIUM FLUORIDEDharma Research, Inc.4749dce1-c0b9-4737-8a30-85cd58aba21b2021-01-25Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AvantSODIUM FLUORIDEDharma Research, Inc.184bbe52-3909-45f6-b4d0-fe7849fabc1c2021-01-25Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium Fluoride 5000 ppm Enamel ProtectSODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%Sheffield Pharmaceuticals LLC83dfdead-4f71-404e-90ae-dbd6849c7cf12021-01-04Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Ionite APF NeutralSODIUM FLUORIDEDharma Research, inc.ad7a660b-274c-417e-bdf3-1d5addf06ad12020-11-18WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.8ff1b377-0535-4548-a109-f9f1a43b85b72020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.e6c31330-43e0-4d32-af54-ff852af39cab2020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.bc9664df-c4eb-4d29-b1c0-4d4dff6a75e42020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.b8b7f9b8-ff11-4a76-ab36-7822c15e18922020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.e1797adf-4665-4322-a3aa-dd2da9dcd3a82020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.ce34c159-34cd-47c7-937f-743b3309742b2020-11-16WarningsExact identifier
unii: 8ZYQ1474W7
Ionite APFSODIUM FLUORIDEDharma Research, inc.503ca71a-f50c-4406-b925-5b6ac36a92122020-11-15WarningsExact identifier
unii: 8ZYQ1474W7
Ionite RSODIUM FLUORIDEDharma Research, Inc.1009afc7-6e9d-417f-a702-f8a941e084842020-11-06Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Ionite RSODIUM FLUORIDEDharma Research, Inc.0e7b3eb3-3a9e-4a51-b2b5-9f36876fc8a52020-11-06Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Ionite APF FoamSODIUM FLUORIDEDharma Research, inc.d22afac7-45d6-467e-951a-e7c241b9180d2020-10-27WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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