FDA.reportPublic FDA data

Tri-Vitamin Drops with Fluoride

Manufacturer
Sancilio & Company Inc
Effective date
2017-12-27
Label type
DIETARY SUPPLEMENT
Version
5
Source
full-release
Hydrated at
2026-06-01 02:48:46

Label at a glance#

ProductTri-Vitamin with Fluoride
Active ingredientVitamin A, Ascorbic Acid, Vitamin D, Sodium Fluoride
Label structure7 sections

Dosage and administration

Use as directed by a physician. Fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. The full dose will be given. It is normal for a small amount to remain in the tip of the dropper. Do not accept if tamper evident box seal is broken or missing.

Label contents#

Full prescribing information#

HEALTH CLAIM SECTION

SHAKE WELL BEFORE USING

DIRECTIONS

HEALTH CLAIM SECTION

Use as directed by a physician.

How to Use:

INDICATIONS & USAGE SECTION

Fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. The full dose will be given. It is normal for a small amount to remain in the tip of the dropper.

Do not accept if tamper evident box seal is broken or missing.

Figure
Figure

STATEMENT OF IDENTITY SECTION

Ingredients

HEALTH CLAIM SECTION

Vitamin A1500 IU
Vitamin C35 mg
Vitamin D400 IU
Fluoride* (as Sodium Fluoride)0.5 mg

* Each 1 mL of Tri-Vitamin Drops contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride (NaF).

Other Ingredients

HEALTH CLAIM SECTION

Glycerin, water, polysorbate 80, sodium hydroxide, propylene glycol, sucralose, fruit flavor, methyl paraben, caramel color, propyl paraben.

Storage

SAFE HANDLING WARNING SECTION

Store in a cool, dry place at room temperature 20°-25°C (68°-77°F) away from heat and sunlight. Store in original container.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222.

Caution

PRECAUTIONS SECTION

Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives) since these may decrease effectiveness.

Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis.

HEALTH CLAIM SECTION

Manufactured by: Sancilio & Co., Inc.
Riviera Beach, FL 33404 USA

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44946-1036-8

SCI
Sancilio &
Company, Inc.
Developing Good Science into Great Medicine

Tri-Vitamin Drops
with Fluoride

VITAMINS A, C, D & FLUORIDE DROPS

NO DYES OR SUGAR
SACCHARIN AND GLUTEN FREE

0.5
mg/mL

1⅔ FL. OZ. (50 mL)

Dispense under a
physician's order†

Dietary
Supplement

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1365984ascorbic acid 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral SolutionSCD5
1365984ascorbic acid 35 MG/ML / cholecalciferol 400 UNT/ML / retinyl palmitate 1500 UNT/ML / sodium fluoride 1.1 MG/ML Oral SolutionSY5
1365984sodium fluoride 1.1 MG (fluoride ion 0.5 MG) / vitamin A palmitate 1500 UNT / vitamin C 35 MG / vitamin D3 0.01 MG (400 UNT) per ML Oral SolutionSY5
1365984vit-C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral SolutionSY5
1365984vitamin C 35 MG/ML / cholecalciferol 0.01 MG/ML / sodium fluoride 1.1 MG/ML / vitamin A palmitate 1500 UNT/ML Oral SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44946-1036-8Tri-Vitamin with Fluoride50 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44946-1036TRI-VITAMIN WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, VITAMIN D, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY INC]51 package rows20171228_3a28cd2e-2766-49a7-a307-e0573c46eb63.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44946-1036-8ML - Milliliter44946-103671041cd3-c9c6-4963-b41d-fdd8339f974d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Ascorbic AcidACTIVE INGREDIENTPQ6CK8PD0R2
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W72
Vitamin AACTIVE INGREDIENT81G40H8B0T2
Vitamin DACTIVE INGREDIENT9VU1KI44GP2
Ascorbic AcidACTIVE MOIETYPQ6CK8PD0R2
Fluoride IonACTIVE MOIETYQ80VPU408O2
Vitamin AACTIVE MOIETY81G40H8B0T2
Vitamin DACTIVE MOIETY9VU1KI44GP2
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T2
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H2
Propylene glycolINACTIVE INGREDIENT6DC9Q167V32
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH2
Sodium hydroxideINACTIVE INGREDIENT55X04QC32I2
SucraloseINACTIVE INGREDIENT96K6UQ3ZD42
WaterINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44946-103644946-1036-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Vitamin A81G40H8B0TACTIB
Ascorbic AcidPQ6CK8PD0RACTIB
Vitamin D9VU1KI44GPACTIB
Sodium Fluoride8ZYQ1474W7ACTIM
GlycerinPDC6A3C0OXIACT
Water059QF0KO0RIACT
Polysorbate 806OZP39ZG8HIACT
Sodium hydroxide55X04QC32IIACT
Propylene glycol6DC9Q167V3IACT
Sucralose96K6UQ3ZD4IACT
MethylparabenA2I8C7HI9TIACT
PropylparabenZ8IX2SC1OHIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 10 · 577 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCAPSULE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IGEL / OPHTHALMIC6 mgExact identifier — unii candidate
174 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4FILM, SOLUBLE / ORAL33 mgExact identifier — unii candidate
22 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ISHAMPOO / TOPICAL3 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ISPRAY / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARYADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IPOWDER, FOR SOLUTION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATUMORADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / NASAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ORAL9 mgExact identifier — unii candidate
174 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
78 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRALESIONAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii candidate
68 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4SOLUTION / ORAL800 mgExact identifier — unii candidate
22 equally ranked IID candidates
SucraloseSUCRALOSE96K6UQ3ZD4TROCHE / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / SUBCUTANEOUS31.45 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IPASTE / DENTAL0.6 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ISPONGE / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PERINEURAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ITABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAVITARYADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32IPOWDER / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium hydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, COATED PELLETS / ORAL0.01 mgExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / ORAL388 mgExact identifier — unii candidate
79 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2b1f573c-eca8-4028-a628-3ae840f53bad3a28cd2e-2766-49a7-a307-e0573c46eb632017-12-27Exact identifier
spl set id: 3a28cd2e-2766-49a7-a307-e0573c46eb63

Reported adverse events (FAERS/openFDA)#

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