FDA.reportPublic FDA data

NDC 44946-1035-8 - 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
Requested NDC
44946-1035-8
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
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

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 24 of 87 · 1,737 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity RinseSODIUM FLUORIDERite Aid Corporationc1a22692-b955-498a-a7c1-1cd7bfd54bda2026-01-30Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Vitamin C SerumVITAMIN CFlexiGo Inc496e7d41-2176-7b0c-e063-6394a90a98f12026-01-28WarningsExact identifier
unii: PQ6CK8PD0R
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Brush Buddies SPIDEY and his AMAZING FRIENDS ANTICAVITY FLUORIDE-Spidey PunchSODIUM FLUORIDEAshtel Studios Inc.023cb63c-52b4-4723-bff6-c25105a53f762026-01-28WarningsExact identifier
unii: 8ZYQ1474W7
Brush Buddies STAR WARS ANTICAVITY FLUORIDE - Saber Strike StrawberrySODIUM FLUORIDEAshtel Studios, Inc.ef4ea4a3-c1ac-447f-a70b-e3a330928cfd2026-01-27WarningsExact identifier
unii: 8ZYQ1474W7
Made by Dentists for Kids Fluoride Anticavity Bamboolicious (Bubblegum)SODIUM FLUORIDEMade by Dentists Inc.f3f6b32d-8e47-4f52-bd9a-20bd51c9d0072026-01-27WarningsExact identifier
unii: 8ZYQ1474W7
Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand GrapeSODIUM FLUORIDEAshtel Studios Inc.6c6d143f-4c2b-4207-bde7-9df8251616a32026-01-27WarningsExact identifier
unii: 8ZYQ1474W7
Brush Buddies TOY STORY ANTICAVITY FLUORIDE - WILD WEST WATERMELONSODIUM FLUORIDEAshtel Studios, Inc.d80d0a87-5d1f-4114-977a-036ffed772052026-01-27WarningsExact identifier
unii: 8ZYQ1474W7
Dialyvite 5000ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUMHillestad Pharmaceuticals USA97791f73-e0c5-45a6-8aed-f456a5466eaf2026-01-27Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Brush Buddies DISNEY FROZEN ANTICAVITY FLUORIDE - Blizzard BerrySODIUM FLUORIDEAshtel Studios, Inc.ac18dd0a-d476-48a7-8493-594a0293b9262026-01-27WarningsExact identifier
unii: 8ZYQ1474W7
DialyviteASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACIDHillestad Pharmaceuticals USA7a5e6dd6-5687-44bb-8964-841961c0e64a2026-01-27Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Brush Buddies Cars ANTICAVITY FLUORIDE - KA-CHOW CHERRYSODIUM FLUORIDEAshtel Studios, Inc.2500e14e-6cf4-4ac4-810f-1ef163c5e4742026-01-27WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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