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 69 of 80 · 1,590 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Lubricant Eye Drops High Performance 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94ee8310-1c19-dfd4-e053-2a95a90a83562023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Walgreens Redness Relief Eye Drops 15mLGLYCERIN, NAPHAZOLINE HCIWalgreen Company94a0d08a-a6db-1088-e053-2995a90ab4fd2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Lubricant Eye Drops Dry Eye 15mL and twin packPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalgreen Company94f6e1cd-073c-61ca-e053-2a95a90ae7252023-12-20WarningsExact identifier
unii: 6DC9Q167V3
Target Eye Drops Maximum Redness Relief EyeGLYCERIN, NAPHAZOLINE HYDROCHLORIDETarget Corporation1b26cd3b-4a05-4623-b320-01f22b3106ff2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
Kroger High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKrogerd2aa8963-1922-02f3-e053-2a95a90a7d932023-12-20WarningsExact identifier
unii: 6DC9Q167V3
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
Topcare Health Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTopco Assoc LLC9c6284f9-00bb-37b5-e053-2a95a90ae2ee2023-12-20WarningsExact identifier
unii: 6DC9Q167V3
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
Topcare Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDETopco Assoc LLC9c6193a6-d824-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
unii: PDC6A3C0OX
Orajel Complete ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.daebd16f-d278-446d-8b7a-33add5a74fdd2023-12-19WarningsExact identifier
unii: 8ZYQ1474W7
Orajel Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEChurch & Dwight Co., Inc.7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb2023-12-19WarningsExact identifier
unii: 8ZYQ1474W7
NEUTRAMAXX 5000 TCPSODIUM FLUORIDEMassco Dental A Division of Dunagin Pharmaceuticalsf47cb584-eb8a-4297-ba32-5f435e85aacb2023-12-17WarningsExact identifier
unii: 8ZYQ1474W7
ORTHO GUARDSODIUM FLUORIDEMassco Dental A Division of Dunagin Pharmaceuticals8d3e0dd0-b584-413b-adf3-5c2d05ab72dd2023-12-17WarningsExact identifier
unii: 8ZYQ1474W7
NEUTRAMAXX 5000 PLUS TURBOSODIUM FLUORIDEMassco Dental A Division of Dunagin Pharmaceuticals3c7584f1-b652-4d82-99e7-10da0ee242c12023-12-17WarningsExact identifier
unii: 8ZYQ1474W7
NEUTRA MAXX 5000SODIUM FLUORIDEMassco Dental A Division of Dunagin Pharmaceuticalsfcbe6baa-2827-49df-9316-42cc865952032023-12-17WarningsExact identifier
unii: 8ZYQ1474W7
Cleareyes Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINLil' Drug Store Products, Inc.39e4ab2b-ae12-4339-b219-109cf0f7f06a2023-12-15WarningsExact identifier
unii: PDC6A3C0OX
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
unii: PDC6A3C0OX
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.db3a6c68-320b-46b0-83fa-6c29297a84a62023-12-15WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLAlcon Research Ltd14916d2c-a63d-491e-bd91-a61f300af38a2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane LubricantPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.15bc06ec-f3dc-3180-ca1a-106769a770ea2023-12-15WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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