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 29 of 89 · 1,770 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prime Tooth Care Hami MelonSODIUM FLUORIDEPrime Tooth Care LLC0028f88d-a9fe-4cfa-a6c6-168f9689b5f62026-01-09WarningsExact identifier
unii: 8ZYQ1474W7
Prime Tooth Care Mango SmoothieSODIUM FLUORIDEPrime Tooth Care LLC2f2cf851-2edc-4aaf-9083-c37bc58547de2026-01-09WarningsExact identifier
unii: 8ZYQ1474W7
Prime Tooth Care StrawberriesSODIUM FLUORIDEPrime Tooth Care LLC7b4328bd-5d2d-40ca-8322-5e818e1babf92026-01-09WarningsExact identifier
unii: 8ZYQ1474W7
Prime Tooth Care Summer WatermelonSODIUM FLUORIDEPrime Tooth Care LLCb7c731a1-80e7-4571-a568-db0290a720c12026-01-09WarningsExact identifier
unii: 8ZYQ1474W7
Kids Prime Pediatric Dental Group Anticavity for KidsSODIUM FLUORIDEPrime Tooth Care LLC93259174-447d-4f7a-8e55-990eb8da51512026-01-09WarningsExact identifier
unii: 8ZYQ1474W7
Walgreens Sensitive Enamel RepairSODIUM FLUORIDEWalgreens41d6384d-695b-b60b-e063-6394a90aa0b92026-01-09WarningsExact identifier
unii: 8ZYQ1474W7
CVS Health Clinical White Stain ProtectorSODIUM FLUORIDECVS Pharmacy41d5c3a9-abe5-5528-e063-6294a90ada792026-01-09WarningsExact identifier
unii: 8ZYQ1474W7
CVS Health Sensitive Enamel RepairSODIUM FLUORIDECVS41d547b3-2feb-8e83-e063-6294a90ae3cd2026-01-09WarningsExact identifier
unii: 8ZYQ1474W7
Moon Platinum Advanced Whitening AnticavitySODIUM FLUORIDEMoon Oral Care LLCded3a5a6-2883-f3de-e053-2a95a90afb942026-01-09WarningsExact identifier
unii: 8ZYQ1474W7
Moon Whitening AnticavitySODIUM FLUORIDEMoon Oral Care, LLC0bdcad3e-b8e9-bd91-e063-6394a90a666a2026-01-09WarningsExact identifier
unii: 8ZYQ1474W7
Sodium Fluoride GelSODIUM FLUORIDEAvPAKde973f9c-af34-4977-e053-2995a90a54a02026-01-09Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
ST MORIZ SUNCARE BODY SUNSCREEN SPF30SUNCARE BODY SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.48026f09-6d15-8fa6-e063-6294a90a17cb2026-01-09WarningsExact identifier
unii: PDC6A3C0OX
Colgate Sensitive Prevent and RepairPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Companye67410dc-a671-4611-8af1-097be071cd1c2026-01-09WarningsExact identifier
unii: 8ZYQ1474W7
Colgate Sensitive plus WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company2092c747-e025-47a9-9e54-731631d3c8312026-01-09WarningsExact identifier
unii: 8ZYQ1474W7
Pyrogenium Combination 9239PYROGENIUM COMBINATIONProfessional Complementary Health Formulas8b869987-bfd2-4451-a2a8-ce3a92e201f22026-01-08WarningsExact identifier
unii: PQ6CK8PD0R
First Chakra (Root) 7301FIRST CHAKRA (ROOT)Professional Complementary Health Formulas61eb1bbe-6675-4369-b852-18975e6b08c72026-01-08WarningsExact identifier
unii: 8ZYQ1474W7
Amalgam 6003AMALGAMProfessional Complementary Health Formulas1af74f69-a23a-45a2-a20e-92bf8b0ccb222026-01-08WarningsExact identifier
unii: 8ZYQ1474W7
Artificial Sweetener Detox 6034ARTIFICIAL SWEETENER DETOXProfessional Complementary Health Formulas38f2ae0b-2b1f-4b49-934d-fe1556f84d932026-01-08WarningsExact identifier
unii: 96K6UQ3ZD4
C-Balance Liquescence 3022C-BALANCE LIQUESCENCEProfessional Complementary Health Formulase209f9bc-9d85-4ab7-8d41-187b65c548722026-01-08WarningsExact identifier
unii: PQ6CK8PD0R
Brain Enhancement Liquescence 3006BRAIN ENHANCEMENT LIQUESCENCEProfessional Complementary Health Formulas33bb2104-c16a-49e4-b292-69e10c1f16c02026-01-08WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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