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 28 of 89 · 1,770 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARU CAVITY PROTECTIONSODIUM FLUORIDEAshtel Studios, Inc.97bd2934-4bff-4fdb-9199-fcdc0f77fada2026-01-13WarningsExact identifier
unii: 8ZYQ1474W7
Colgate Sensitive Enamel HealthPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Companya50d4259-8a79-417e-b381-72c7a8ec04182026-01-13WarningsExact identifier
unii: 8ZYQ1474W7
ACT Anticavity Fluoride CinnamonSODIUM FLUORIDEChattem, Inc.f2952ca5-c1c3-42fc-82a4-08662286be442026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
ACT Anticavity Fluoride Kids Wild WatermelonSODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION)Chattem, Inc.bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a82026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
ACT Kids Anticavity Fluoride Pineapple PunchSODIUM FLUORIDEChattem, Inc.2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b2026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
Botao Kids Strawberry Flavored with FluorideBOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDEPeer Pharm Ltd.48b8d884-5e15-4145-8521-ae9ee482e3922026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
ACT Total Care Anticavity Fluoride Fresh MintSODIUM FLUORIDEChattem, Inc.4ee6a478-afcf-4540-b427-ba08c942ccb32026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
ACT Anticavity Fluoride MintSODIUM FLUORIDEChattem, Inc.e81c83a2-363a-442f-8731-2598a4f4c21e2026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
ACT Total Care Anticavity Fluoride Icy Clean MintSODIUM FLUORIDEChattem, Inc.258b78b4-55e7-410c-90f8-a3e456c025792026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
ACT Total Care Dry Mouth Anticavity MouthSODIUM FLUORIDEChattem, Inc.06684b82-aaa0-4ca6-8d56-4f98662690002026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
ACT Anticavity Fluoride Kids Groovy GrapeSODIUM FLUORIDEChattem, Inc.cd167c0b-2086-4204-b0ac-90df404bd4bb2026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
ACT Total Care Anticavity Fluoride Icy Clean MintSODIUM FLUORIDEChattem, Inc.beded786-bb55-4ba3-82fe-9e9d1b5e29792026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
ACT Kids Pure Protect Anticavity- Simply StrawberrySODIUM FLUORIDEChattem, Inc.2fc80727-57c7-4a33-80e0-ab9f9487390d2026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
ACT Kids Anticavity Fluoride Groovy GrapeSODIUM FLUORIDEChattem, Inc.310a3c11-1c66-4dac-99f4-5fdc15d0f77c2026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
ACT Anticavity Fluoride Kids BubblegumSODIUM FLUORIDEChattem, Inc.fbbccd58-a816-4a93-a658-f28246c11e802026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
ACT Whitening Anticavity Gentle MintSODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION)Chattem, Inc.cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf492026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
ACT Restoring Anticavity Fluoride Cool MintSODIUM FLUORIDEChattem, Inc.ef63e193-5804-4b35-bae7-cad29cf4e8bc2026-01-12WarningsExact identifier
unii: 8ZYQ1474W7
Prime Tooth Care BlueberrySODIUM FLUORIDEPrime Tooth Care LLC86642110-4572-4b8b-88f1-8d25fe05701e2026-01-09WarningsExact identifier
unii: 8ZYQ1474W7
Prime Tooth Care Juicy PeachSODIUM FLUORIDEPrime Tooth Care LLC142f1610-3494-459f-a956-760e82169b872026-01-09WarningsExact identifier
unii: 8ZYQ1474W7
Prime Tooth Care Coconut WhipSODIUM FLUORIDEPrime Tooth Care LLC55e95657-9415-4d9c-ac9b-d021aa14e64d2026-01-09WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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