FDA.reportPublic FDA data

NDC 44946-1035 - Tri-Vitamin with 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
44946-1035
Package NDCs from labels
44946-1035-8
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
Tri-Vitamin with Fluoride - Sancilio & Company IncSancilio & Company Inc2018-03-06DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44946-1035-8Tri-Vitamin with Fluoride50 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS505
44946-1035-8Tri-Vitamin with Fluoride1 in 1 CARTONSOLUTION/ DROPS15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44946-1035TRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]52 package rows20180329_22a4dc9a-4963-4def-a4ac-2c40dbcbeb82.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44946-1035-8ML - Milliliter44946-1035b6f7edd1-4405-4dee-9dee-295d7272ef3e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ascorbic AcidACTIVE INGREDIENTPQ6CK8PD0RTRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7TRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
Vitamin AACTIVE INGREDIENT81G40H8B0TTRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
Vitamin DACTIVE INGREDIENT9VU1KI44GPTRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
Ascorbic AcidACTIVE MOIETYPQ6CK8PD0RTRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
Fluoride IonACTIVE MOIETYQ80VPU408OTRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
Vitamin AACTIVE MOIETY81G40H8B0TTRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
Vitamin DACTIVE MOIETY9VU1KI44GPTRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXTRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TTRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3TRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHTRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
Sodium hydroxideINACTIVE INGREDIENT55X04QC32ITRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4TRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]2
WaterINACTIVE INGREDIENT059QF0KO0RTRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM 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 85 of 89 · 1,770 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inc852de04d-f608-4f7f-b76b-25a29967c0902022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inccec13e9e-2b99-48a1-9833-c49b18c726142022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inc7da82945-3186-40b2-b67e-642bdfa9578a2022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inca481e755-6a82-4634-9aa6-bfc7325ccd2c2022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Incbe046466-234e-4742-9bdb-12a13caa6b472022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Tiger Supply Inc APFSODIUM FLUORIDETiger Supply Inc6631aeb7-d892-41dc-97e3-655a8059734f2022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Zap APFSODIUM FLUORIDECrosstex International Inc.0da6a9de-ad38-4c75-8e88-b68dfc638edc2022-01-20WarningsExact identifier
unii: 8ZYQ1474W7
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

Reported adverse events (FAERS/openFDA)#

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