FDA.reportPublic FDA data

Multivitamin Drops with Fluoride

Manufacturer
Sancilio & Company, Inc.
Effective date
2018-03-08
Label type
DIETARY SUPPLEMENT
Version
3
Source
full-release
Hydrated at
2026-06-01 02:48:53

Label at a glance#

ProductMultivitamin Drops with Fluoride
Active ingredientVitamin A, Ascorbic Acid, Cholecalciferol, Tocopherol, Thiamine, Riboflavin, Niacinamide, Pyridoxine, Cyanocobalamin, Sodium Fluoride
Label structure7 sections

Dosage and administration

Use as directed by a physician.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Supplement Facts
Serving Size: 1 mL
Servings Per Container: 50
Amount per serving% Daily Value*
Percent Daily Value (%DV) based on a 2,000 calorie diet.
Vitamin A1,500 IU60
Vitamin C35 mg88
Vitamin D400 IU100
Vitamin E5 IU50
Thiamine0.5 mg71
Riboflavin0.6 mg75
Niacin8 mg89
Vitamin B60.4 mg57
Vitamin B122 mcg67
Fluoride (as Sodium Fluoride)0.5 mg†

* Daily Value for children 6 months to 4 years old.

† Daily Value not established.

Ingredients: Purified Water, Glycerin, Propylene Glycol, Ascorbic Acid, Polysorbate 80, Niacinamide, Sodium Hydroxide, D-alpha-Tocopheryl Acetate, Sucralose, Natural Grape Flavor, Methyl Paraben, Caramel Color, Vitamin A Palmitate, Riboflavin Sodium Phosphate, Sodium Fluoride, Sodium Benzoate, Thiamine HCl, Sulfuric Acid, Cholecalciferol, Pyridoxine HCl, Ferrous Sulfate Monohydrate, Cyanocobalamin.

WARNING

WARNINGS SECTION

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

SHAKE WELL BEFORE USING

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Use as directed by a physician.

How to Use

HEALTH CLAIM 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.

Storage

HEALTH CLAIM SECTION

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

HEALTH CLAIM SECTION

Manufactured by:
Sancilio & Company, Inc.
3874 Fiscal Court
Riviera Beach, FL 33404
(800)SCI-8711

REV 3/21/17

Made in the USA

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

44946-2006-8

Multivitamin Drops
with Fluoride

*Each 1 mL provides 0.5 mg Fluoride

NO DYES OR SUGAR
SACCHARIN AND GLUTEN FREE

0.5*
mg/mL

1⅔ FL. OZ. (50 mL)

Dietary
Supplement

Dispense under a
physician's order

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
1234482ascorbic acid 35 MG/ML / cholecalciferol 400 UNT/ML / niacin 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / thiamine 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSCD3
1234482ascorbic acid 35 MG / cholecalciferol 400 UNT / niacin 8 MG / riboflavin 0.6 MG / sodium fluoride 0.55 MG (fluoride 0.25 MG) / thiamine 0.5 MG / vitamin A 1500 UNT / vitamin B 12 2 MCG / vitamin B6 0.4 MG / vitamin E 5 UNT per ML Oral SolutionSY3
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY3
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY3
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY3
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY3
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY3
1234482vit-C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY3
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY3
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / nicotinic acid 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY3
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY3
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vit-B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY3
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vit-B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY3
1234482vitamin C 35 MG/ML / cholecalciferol 400 UNT/ML / vitamin B3 8 MG/ML / riboflavin 0.6 MG/ML / sodium fluoride 0.55 MG/ML / vitamin B1 0.5 MG/ML / vitamin A 1500 UNT/ML / vitamin B12 0.002 MG/ML / vitamin B6 0.4 MG/ML / vitamin E 5 UNT/ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310
VITAMIN A Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44946-2006-8Multivitamin Drops with Fluoride50 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44946-2006MULTIVITAMIN DROPS WITH FLUORIDE (VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, CYANOCOBALAMIN, AND SODIUM FLUORIDE) SOLUTION/ DROPS [SANCILIO & COMPANY, INC.]31 package rows20180324_841737bf-06d1-40c5-b2c8-7e0940a2cd71.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44946-2006-8ML - Milliliter44946-20063ebf1f3c-9ce7-409c-8408-c61215c2c39312017-06-15

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44946-200644946-2006-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
Vitamin A81G40H8B0TACTIB
Ascorbic AcidPQ6CK8PD0RACTIB
Cholecalciferol1C6V77QF41ACTIB
TocopherolR0ZB2556P8ACTIB
ThiamineX66NSO3N35ACTIB
RiboflavinTLM2976OFRACTIB
Niacinamide25X51I8RD4ACTIB
PyridoxineKV2JZ1BI6ZACTIB
CyanocobalaminP6YC3EG204ACTIB
Sodium Fluoride8ZYQ1474W7ACTIM
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Propylene Glycol6DC9Q167V3IACT
Polysorbate 806OZP39ZG8HIACT
Sodium Hydroxide55X04QC32IIACT
Sucralose96K6UQ3ZD4IACT
MethylparabenA2I8C7HI9TIACT
CaramelT9D99G2B1RIACT
Sodium BenzoateOJ245FE5EUIACT
Sulfuric AcidO40UQP6WCFIACT
Ferrous Sulfate, DriedRIB00980VWIACT

Source Document#

Source XML

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
4f5621a2-bf92-48c2-ad7c-ff0da68909e3841737bf-06d1-40c5-b2c8-7e0940a2cd712018-03-08WarningsExact identifier
spl set id: 841737bf-06d1-40c5-b2c8-7e0940a2cd71

Reported adverse events (FAERS/openFDA)#

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